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Analysis EO
Apr 16, 2020
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Analysis EO
Apr 16, 2020

First Come, First Cured: Chinese Drugmakers Race for COVID-19 Solutions

As the pandemic further ravages this world, global medical researchers and developers are trying to save people from fear and pain. According to the WHO (World Health Organization), three candidate vaccines are already being tested on humans, with the other 67 candidates at the pre-clinical stage. Among the three quick actors, China’s CanSino Bio has moved along the furthest, into Phase II, followed by Inovio Pharmaceuticals and Moderna at Phase I.  CanSino Biologics announced on April 9 the initiation of a Phase II clinical trial on human bodies in a joint effort with the Academy of Military Medical Sciences. It claimed to have obtained periodic achievements in Phase I clinical trial for the Recombinant Novel Coronavirus Disease Vaccine (Adenovirus Type 5 Vector, or the ‘Ad5-nCoV’), in a joint effort with Academy of Military Medical Sciences.  The Phase I trial started from March 16 and gave preliminary safety data based on 108 samples aged between 18 and 60. The second study is designed for a more profound objective, to evaluate the immunogenicity for Adenovirus Vector in healthy adults over 18, and on a larger sample group of 500 people. As disclosed on ChiCTR (Chinese Clinical Trial Registry), blood and urine are collected at Phase II, instead of serum and PBMC (Peripheral Blood Mononuclear Cell) at Phase I. Future test participants will be recruited in a randomized and blinded method for experimental vaccines.  Like it or not, most vaccines take more than a few months to reach the public’s hands, or between five years and 15 years to go perfect. As stated by Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease in the US expects, a vaccine takes 18 months to go public. As shown on the WHO, the pre-licensure studies assess three mandatory clinical trial phases before the vaccine introduction and monitor acute undesirable reactions with over one in 10,000 vaccines. More Chinese names on the WHO list Financially supported by the Ministry of Science and Technology, the biotechnology CanSino Bio will conduct this ‘randomized, double-blinded, placebo-controlled’ clinical trial in three hospitals in Wuhan, the epicenter.  The Tianjin-based generic manufacturer previously developed the first-ever Asian vaccine against the Ebola virus early in 2014  (Ad5-EBOV)  and was approved for national stockpile and emergency use in 2017. Since being listed on the Hong Kong public market in March in 2019, the company has been eyeing another IPO in China’s Star Market this year, seeking a sufficient bankroll for scaling up vaccine research and production.   The WHO’s approved candidate list mentions that other Chinese biotechnologies are also running in the race of developing vaccines, while most are at the pre-clinical stage.  Fosun Pharma (2196: HKSE), in collaboration with BioNTech and Pfizer, is working on the vaccine based on micro RNA at the pre-clinical stage. Innovax (2680: HKSE), together with Xiamen University and GSK, is researching a vaccine in the type of truncated S (spike) proteins. Beijing CC-Pharming and iBio, Inc (IBIO: NYSE) are working together on the subunit protein-based vaccine by leveraging CC-Pharming’s 25 R&D experience in Middle East Respiratory Syndrome (MERS-CoV) and iBio’s FastPharming System  for fast plant-based biopharmaceutical production. Sinovac Biotech (SVA: Nasdaq), known as the first company with approved SARS vaccine trials on humans back in 2004, headed into this meaningful project immediately. It is also the only Chinese company seeking an inactivated vaccine solution. What is behind these names is the ever-expanding vaccine market in China. The vaccine market size is projected to grow at a compound annual growth rate of 11.88% going forward. Private vaccine business expects to serve as the primary market driving force, considering that two vaccine-related scandals in 2016 and 2018 have left confidence stains on the public vaccine system. Drugs for current unmet needs The vaccine is about precaution strategy – how to prevent diseases for the non-infected people, while therapeutic drugs are for infected patients. Unfortunately, there is no special treatment for this deadly pathogen yet. WHO initiated an international clinical trial called ‘Solidarity’ to test and find an effective solution. This global initiative, involving over 90 countries, provides four options: Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon beta-1a; and Chloroquine or Hydroxychloroquine. As reported, these drugs have been tested in many Wuhan-based hospitals since the outbreak. Although it is still too early to talk about a specific drug for COVID-19, a treatment for the pathogen-associated complication is within sight. Empirical research into severe COVID-19 cases points out that the cytokine release syndrome (CRS) is one of the major reasons for the fatality of the new coronavirus. University College London’s article in the Lancet also mentioned the positive correlation between the severity of the cases and the occurrence of the cytokine storm. There is a nearly 20% chance that the attacked immune system overwhelmingly fights against the virus in a ‘suicidal’ manner, resulting in an overall systematic dysfunction.  I-Mab Biopharma (IMAB: Nasdaq), a Chinese biotech company, is currently focusing on developing medical solutions to contain this immuno-overreaction. Understanding the unmet needs for treating CRS on the anti-epidemic frontline, the team initiated studies into TJM2, an antibody to prevent overreaction of the immune cells and stem further circulatory collapse and organic degeneration. This Shanghai-based firm just went to list on the Nasdaq stock exchange this January. From 2016, the young biotech has exclusively studied innovative drugs for oncological and autoimmune disorders. Though no drug has been introduced to the market yet, it has won the favor of long-term investors by its dedication in drug innovation, indicated by 12 promising pipelines and CNY 426 million R&D expenses in 2018, or 86.5% of total expenses. Undoubtedly, there is a robust correlation between R&D expenses and the value of a tech-driven company. China’s Star Market sets 15% as the alert benchmark for evaluating candidate companies’ IPO status quo. The total pharmaceutical R&D spending by Chinese companies is projected to outnumber that of US peers in 2023, reaching USD 50 billion. Reaping the reward of the policy reform and early investment It is notorious that in old days a new drug could take decades to complete the approval process, leaving a lag of between six and eight years compared to other countries. Since 2015, the China Food and Drug Administration (CFDA) has issued several policies to facilitate the drug innovation, proposing a fast-track approval procedure for clinical trials. A direct result is that the new drug approval process in 2018 is shortened to a little over three years, compared to the average 12 years in the US.   The year 2019 witnessed a more profound reform with laws on vaccine management and drug management. A total of 56 new drugs were approved last year by CFDA, outnumbering 48 newly licensed medicines in the US. Another driver is the increasing capital activities. There is a clear upward trend of investment in China’s healthcare industry, including both VC/PE investors and secondary market watchers. In 2018, the capital injection flowing into the China life-science industry reached a new high record of USD 17.3 billion in a total of 696 investment deals. Among all these targets, the drug business segment was the winner portfolio for VC institutions, representing 44% of the total investment amount, followed by the Internet healthcare segment of 29%. As for the public market in China’s healthcare industry, the year 2018 was also a milestone in terms of IPO activities. There is a Chinese saying that an old man lost his horse but eventually gained good fortune,   similar to a blessing in disguise. While there is no ending in sight for this turbulent global situation for now, with the extreme phase of the Chinese outbreak under control, it seems that first experience with the unknown virus has brought Chinese scientists precious time to study. If treatments or vaccines are rushed to market or testing without proper preparation however, they may still finish up the race as losers.

Analysis
Jan 23, 2020 · 36Kr
Analysis EO
Jan 16, 2020
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Analysis EO
Jan 16, 2020

Chinese Immuno-Oncology Firm I-Mab's IPO Lands on NASDAQ

Chinese antibody developer I-Mab Biopharma's (IMAB) long-anticipated IPO lands on NASDAQ on 16 January, in a move to bankroll its ongoing oncological drug pipelines following the successful landing of USD 100 million. The company is the first Chinese biotech company to do so in around two years, as most of the companies from the mainland have forayed into the Hong Kong Stock Exchange, thanks to the updated regulatory approval process at the Fragrant Harbour's bourse. The IPO date is pregnant with meaning, in the sense that it is just after JPMorgan's healthcare event in SF – healthcare private equity heavyweights have whispered for the entire week on what they think may be a lucrative deal to take. Prior to its initial public offering, the cancer drug developer has issued over USD 300 million worth of shares to a plethora of venture capitalists and private equity arms of pharmaceutical behemoths, including Wuxi Apptec's (SH: 603259) venture capital arm and Ally Bridge Group, a new amendment onto the company's IPO filing revealed. The company's primary market investors, Caesar Pro Holdings Limited, Wuxi Biologics, and Hongkong Tigermed, overvalued the company in its Series C-1 by offering USD 16.1 per ADS in the fall of 2019, the amendment has also revealed. The firm is expecting to price its shares within a price range of USD 12 to USD 15 by offering 7.4 million in ADS to the public. The company sees its novel or "highly differentiated" drugs TJ202, TJ107, enoblituzumab, and TJ101, as the four anchor assets in its China Portfolio, and planning to support them by the windfall of the public funds. China is one of the flag-carriers of cancer immunotherapy and the number of active drugs in development grew 91% between 2017-2019. I-Mab will be representing China's IO advancements in the US, and EqualOcean will keep watching this firm: as we have been doing from the get-go.. 

Analysis
Jan 7, 2020 · EO Company
Analysis EO
Nov 12, 2019
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Analysis EO
Nov 12, 2019

Biotech in China: Oasis in the Desert?

The world's second-largest market for the pharmaceutical industry and biotech is currently reaping the fruits of the result-driven regulation reforms and cutting edge technologies to provide healthcare for its 1.4 billion citizens. Besides the macro drivers, such as changing demographics and enriching the middle-class, the Chinese biotech industry was further fostered by the regulatory overhaul and outstanding developments in particular areas such as immuno-oncology and deep learning-driven techniques. Regulatory rejuvenation from top to toe The China Food and Drug Administration (CFDA), now under the National Medical Products Administration (NMPA), had intended to transform the Chinese pharmaceutical industry by introducing a series of regulations, and it partially succeeded. Since early 2016, Chinese regulators have been updating the overall drug registration and related policies to create a well-working domestic pharmaceutical industry, as well as to provide cheaper drugs and medicine for the public.  First, the regulators freed the drug developers from the lengthy procedures in the approval course, accelerating the entire process of approval. 774 applicants benefited from the regulatory update in 2018, McKinsey found. Secondly, a set of regulatory updates facilitated multinational novel drug developers' drug distribution procedures in China, making operational deployment in the mainland even easier for pharmaceutical multinationals. Thirdly, drug developing licensing procedures have been eased for third party drug developers and Contract Research Organizations (CROs), creating a brand-new development channel for CROs in China. Last but not least, the regulators announced that they'd include high-priced, novel and innovative drugs into the reimbursement lists, creating a massive wave of R&D investment into these therapies: namely, genomics, immunotherapy, and other cutting-edge therapeutics.  Private Equity investors' foray into Chinese biotech startups In fact, the optimistic atmosphere had started long before the specific regulatory updates, with a couple of visionary plans introduced by the central government, namely, 'Made in China 2025' and 'Healthy China 2030'. The regulatory overhaul was the final move that put the pieces together in China's biotech and pharmaceutical industry. China's once generic-dominated drug development scene is transforming; it is becoming feasible for novel drug developers to shape the industry. On both the supply and demand sides, the Chinese pharmaceutical industry will stay as one of the critical pillars of the primary market investment drivers in China, and ultimately its contribution to public markets is expected to be consolidated. The growth-stage vanguards of China's biotech field There has been an outstanding increase in immunotherapy, antibodies, and genomics focused companies in China. The country has a high incidence of malignant tumors, with nearly 4 million new cancer cases diagnosed each year. Thereby, immunotherapy and oncology companies that are developing innovative solutions for cancer have mushroomed in the mainland. The trend is fostered by the regulators. The approval of Nivolumab in China in June 2018 for treating non‐small cell lung cancer (NSCLC) in adult patients made available the first immune checkpoint inhibitor in China. One month later, the NMPA granted Merck's Keytruda (pembrolizumab) approval in combination with pemetrexed and platinum chemotherapy to treat patients with metastatic NSCLC. Numerous start-ups scaled their businesses, meanwhile. I-Mab Biopharma, a Shanghai-based clinical-stage Immuno oncology provider, filed for a much-anticipated IPO with the US Securities and Exchange Commission at the end of October 2019, aiming to raise up to USD 100 million. The firm is focused on developing new therapeutics for cancer by immunotherapy. Shanghai Cell Therapy Group, another prospective startup, is a developer of precision medicine through cell therapy. Established in 2000, the company is offering cancer diagnosis and treatment, and services that include cell production, cell cryopreservation, genetic testing, and cell-related products. The company has raised more than CNY 2 billion in total, led by Legend Capital, Haier Capital and China Industrial Asset Management. What's next? Human resources in life sciences and R&D accumulation are the essential assets of biotech companies. There was a massive divergence before the year 2000 in the annual number of biotechnology patents granted between the US and China. From 2007-2012, the number of biotechnology research publications from Chinese institutions increased year-to-year by an average of 20 percent and realized a catching-up trend. Finally, in 2012, Chinese publications outnumbered those of in the US. Meanwhile, the Chinese central government had initiated a talent cultivation plan called 'Thousand Talents Programme' to bring about the necessary talent pool in life sciences and other strategic areas in 2008, by utilizing foreign talents in the mainland. On the other hand, 352,000 Chinese students have studied life sciences in the US as of 2017. Most of them are studied chemistry and engineering, UBS found.  There is no silver bullet for Chinese in their arduous journey to create a competitive biotech and pharmaceutical industry. Still, the industry will be gradually leveraging its standards up to higher than those of contenders as its research environment is saturated. And this is a long-term-only transformation.

News
Oct 15, 2019 · PR_Newswire
News EO
Sep 19, 2019
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News EO
Sep 19, 2019

A Wave of Fresh Price Cuts Hits China’s Generic Drugs Scene

Jiangsu Public Resource Trading Platform -a regulatory bureau responsible for the public biddings- issued a statement on September 4th, adjusting the prices of 10 new generic medicines. The adjustment marked yet another major price cut by the Chinese regulators following the "4+7" reform, a rule issued by the National Medical Products Administration (NMPA) at the end of 2018 which changed the rules of the game in China’s biopharmaceutical industry. The term 4+7 refers to the 11 cities that the pilot program has been initiated in, was set to stimulate the decentralized tender system for the generic drugs by awarding the contract to the lowest bidder – i.e., the pharmaceutical manufacturers with the lowest bidding prices get the rights of distribution of selected medicines in these 11 Chinese cities. The list includes, among others, Beijing, Shanghai, Shenzhen and Guangzhou. Since its inception, the bulk-buy policy has caused a freefall of up to 90% for some of these medicines’ prices, creating a panicked atmosphere in the markets. What’s more, The Chinese pharmaceutical industry is on the brink of another price cut wave, according to iyiou.com, the sister publication of EqualOcean. The new regulatory landscape has also affected multinational companies, mostly positively. The number of foreign drug applications submitted in China from 2016 to 2017 surged threefold from 13 to 37, reported Pharmaceutical Technology. In 2018, NMPA upgraded another policy, accepting overseas clinical trial data for applications in the mainland. The new policy would even affect online pharmacies in the sense that they need to negotiate more with novel drug producers, of which a significant number are foreign enterprises. Tiger Global backed Chinese B2B pharmaceutical trading platform Yaoshibang (药师帮) represents one of those companies that would presumably update its marketing approach in the near future.  As NMPA continuously ramps up its efforts to push down generic medicine prices, China’s biopharma field will bring about new paradigms, urging generic drug producers to upgrade their operating models, leaning towards producing more novel drugs. In future, China may create its own competitive novel drug developers. Beijing-based Jacobio (加科思), and I-Mab Biopharma (天境生物), a biotech startup from Shanghai that was said to go public soon, are the examples of China’s prospective novel drug developers in the near future. 

News EO
Sep 8, 2019
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News EO
Sep 8, 2019

Healthcare Industry Maintains Agility as China's PE Scene Cools Down

The healthcare industry led PE transactions for the second quarter of 2019 in China, with around CNY 18.8 billion in transactions in total. Even as Chinese primary market investments have lost their upward trend since 2016, the healthcare industry remains an exceptional field that has retained its attractiveness for many investors. Healthcare was followed by the Information Technology (IT) and Internet fields, with CNY 17.3 and 11.5 billion, respectively. Healthcare PE also boasted the highest average transactions for the same period, PEdaily reported.  Chinese healthcare PE analysts refer to the industry as the “Evergreen Industry” (长青行业). However, the viability of this statement may be even beyond China: Global healthcare PE activity rose to record levels yet again in 2018. The total disclosed value of deals reached USD 63.1 billion, the highest recorded since 2006, and the deal count grew to 316 from 265 in 2017, according to Bain & Company. During the first half of 2019, investor attention was drawn towards Chinese healthcare services with a medical aesthetic company's IPO submission in the US, So-Young Int. (SY: NASDAQ). There are several more firms from China's health scene that are rumoured to be considering filing in the US.  Shanghai-based drug developer, I-Mab Biopharma, and Medical AI developer Yitu Technology are two other companies that said to be preparing to file in the US; neither company explicitly rejected the speculations.  During the first half of 2019, JD.com Inc. (NASDAQ: JD) subsidiary raised over USD 1 billion from CPE China Fund and CICC Capital in its Series A financing round, marking one of the largest transactions of the period.  Changing demographics and continuously reforming social policies are bringing about a feasible ground to cultivate new fields within healthcare services. China is catching up in several businesses with the world leaders, that are the European countries and the US in healthcare.  "China’s Medicare or Healthcare Insurance sector is simply primitive and inefficient, which will be regulated by the government for better. We are closely following and actively engaging in those data-driven healthcare insurance companies to seize this very critical industry. It is critical because the rest of the Healthcare industry is tied to Medicare." said Sun Wei, partner of a Shanghai-based healthcare private equity.  Viable fundamental macro indicators one side, relatively higher returns on the other: China's healthcare private equity players are operating in an optimistic atmosphere amidst global uneasiness of capital markets.

News EO
Aug 7, 2019
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News EO
Aug 7, 2019

Biotech Startup Huadao Raises CNY 100 Mn to Develop CAR-T

NKY Medical Holdings Ltd (300109: SZ) injected CNY 100 million into a Biotech startup in Shanghai, titled Huadao Bio-Medicine (华道生物), in a move to forge ahead in the CAR-T development race. CAR-T, yet another technique in utilizing cell therapy for cancer, is regarded as one of the most sophisticated therapies in cancer and has attracted significant PE/VC investment since 2018, in China.  Huadao, a latecomer for China's immuno-oncology field, was established in September 2017 under the motto "Affordable cell therapy for China's middle class," and received its Series A financings from New Horizon Capital (新天域资本) and Oceanpine Capital (海松医疗基金). Indeed, several others trying to conquer the same field in China. I-Mab Biopharma (天境生物), a Shanghai-based biopharmaceutical startup, which was rumoured to go public in 2019, has been one of the most assertive privately-held immuno-oncology firms in China. Over three rounds, the company has raised USD 370 million as of August 2019; and is seeking up to $40 million in private funding round, Bloomberg speculated.  However, China is lagging in the development of CAR-T. Biopharma projects from Europe, Israel and the USA are dominating the scene since the beginning of 2013. Between 2013 and 2015, the public market has shown its interest in advanced therapeutics stocks, in which most of them are developing CAR-T: the companies have raised over USD 1 billion in their IPOs, the report revealed.  The investor, NKY Medical, is a publicly-traded chemical producer on the Shenzhen bourse and it is operating in numerous arms, including biopharma. Its share price dropped around 5% after the latest trade and exchange rate disputes. Huadao claimed to create China's first fully-independent CAR- T Industrial transformation and production technology platform with entirely-owned intellectual properties. Indeed, the company is targeting an area where there is vast room to improve within the mainland.

Analysis EO
May 15, 2019
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Analysis EO
May 15, 2019

4 Chinese Immunotherapy Companies to Keeps Tabs On in 2019

Biopharmaceutical company NextCure's IPO at NASDAQ on May 7th yet again attracted investors' attention to the immunotherapy products. The consensus has already been held by the National Academy of Medicine (NAM) towards the efficacy of cancer immunotherapy. Four Chinese pharmaceuticals are developing auspicious cancer immunotherapy drugs to provide a recipe for the unmet needs of China's healthcare market.  Although the treatment process possesses several complications, it works. Lung cancer is the leading cause of the cancer-related mortality in China, with non-small cell lung type of cancer (NSCLC) accounting for over 85% of all cases. NAM provides evidence-based recommendations to help clinicians integrate immune checkpoint inhibitors into the treatment plan for patients with NSCLC.  EqualOcean picked four companies that are providing cutting-edge solutions in China's rising healthcare industry: I-Mab Bio (天境生物), Jacobio (加科思), YuceBio (裕策生物) and Shanghai Cell Therapy Group (上海细胞治疗集团). These pharma groups operate in several areas of cancer treatment, including immunotherapy. Some of these four companies have already launched their FDA approved clinical stage products, like Jacobio; and all of them are furiously growing.  What Pushes the Interest in Immuno-oncology (IO)?  Compared to traditional surgery, chemotherapy, radiotherapy and other means; immuno-oncology has relatively fewer side effects and has shown strong efficacy in curing malignant diseases, particularly melanoma. EqualOcean foresees significant improvements in cancer treatment via several methods of IO. "The global cancer-immunotherapy market is expected to grow rapidly with a rising CAGR of 14.6% during the forecast period of 2016 to 2024." forecasts Transperancy Market Research.  The shortcomings of the conventional treatments together with ceaselessly increasing cancer diagnosis rates further attracted the attention to immunotherapy. While radiotherapy and chemotherapy target malignant cells via radiation and various chemicals, they are bringing about several side-effects.  Distinctively, immunotherapy strengthens patients' immune system to eliminate the cancerous cells. The main therapies used include checkpoint inhibitors and CAR-T cell therapy. CAR-T cell therapy aims to transform human T-cells in order for them to recognize tumour antigens and stimulate the immune system to remove cancer cells. Relevant research has entered the commercial market and its efficacy has been postulated several times. Immune Checkpoint Inhibitors of Immunotherapy Checkpoint inhibitors are a type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help to keep immune responses in check and can keep T cells strong enough to destroy the cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells. In short, this therapy aims to help the patient's warrior cells to eliminate the cancerous cells.  What is significant about this type of immunotherapy is that it provides new solutions to fight against lung cancer.  "Lung cancer is the leading cause of cancer-related mortality worldwide, with non-small cell lung cancer (NSCLC) accounting for over 85% of all cases. Until recently, chemotherapy – characterized by some benefit but only rare durable responses – was the only treatment option for patients with NSCLC whose tumors lacked targetable mutations. By contrast, immune checkpoint inhibitors have demonstrated distinctly durable responses and represent the advent of a new treatment approach for patients with NSCLC," states the article published on Journal for ImmunoTherapy of Cancer The article postulates that more than 85% of all lung cancer cases can be considered to advised immune checkpoint inhibitors therapy; if the prerequisite conditions are satisfied for immunotherapy. I-Mab Biopharma I-Mab is a biopharmaceutical company with a focus on biologics in the therapeutic areas of immuno-oncology and immuno-inflammation. Its independently developed CD47 targeted human monoclonal antibody TJC4 was approved by the US Food and Drug Administration (FDA) for clinical research. On 29 November 2018, I-Mab and TRACON Pharmaceuticals announced strategic partnerships for multiple immuno-oncology programs.  The R&D team is led by Zang Jingwu (臧敬五), a venerable biopharmaceutical scientist that has published papers as the first author on The Lancet. Under his leadership, I-Mab is developing biologics in immune-oncology and autoimmune areas. They have accumulated four rounds of financing since its incubation in 2016, receiving more than USD 380 million. It has also acquired Tasgen (天视珍生物) in March 2017, which is a company focusing on autoimmune diseases. I-Mab Biopharma is backed by wealthy investors like Hillhouse Capital (高瓴资本) and CDH Hund (鼎晖资本), with a history of extensively investing in healthcare companies. Bloomberg speculated that the company is to target up to USD 500 million in IPO and scheduled its initial public offering to presumably in the first half of 2019. YuceBio YuceBio is a biotech company focusing on cancer immunotherapy and assistive cancer diagnosis detection systems.  Founded in 2015 in Shenzhen, the company is the first biotech concentrating in immunotherapy R&D on gene detection and big data. YuceBio’s “Ladder for Cancer Moonshot” project aims to build a collective gene database for R&D purpose and will apply AI and big data techs to analyze collected genetic and clinical data to gain a deeper understanding of the relationship between genotype and immunity and the mechanism of the immune system in cancer treatment. (Read more) IDG capital partner Yang Fei (杨飞), who has invested in several of well-known companies such as Tencent, Baidu, Ctrip, believes that Yuce Bio will continue to strengthen its leading position in the field of cancer immunotherapy in China. The IDG medical team has been paying attention to the development of tumour immunotherapy. Led by IDG, YuceBio completed several hundred millions of B round financing in 2018 October, strengthening its leading place in tumour immunology. Jacobio Jacobio's antineoplastic drug JAB-3068’s clinical trial plan is under CFDA’s review, though the plan has already been approved by the US FDA in January 2018. Jacobio has also gained the support of the science and technology fund in the development zone of Beijing. Following the state-support, it has attracted many private capitals to follow up the company. "Benefiting by comprehensive support provided by the development zone, the company's development progress is much faster than expected. At present, the main clinical research JAB-3068 is progressing smoothly in China and the United States." Wang Yinxiang (王印祥), the chairman of Jacobio, stated. Shanghai Cell Therapy Group SCTG is a high-tech company aiming to provide diagnosis and treatment services through precision medicine technics. SHCTG have hospitals, R&D centres, clinical immunotherapy centres and a cell bank in Shanghai. The ecosystem drives SCTG with a strong backup and elevates the efficiency in R&D progress, which is the core power of SCTG. Founded in 2011, SCTG has completed three funding series at a total value of CNY 1.24 billion (USD 182 million), in which Legend Capital(君联资本) led the Series B, and followed in recent series C funding. Nonetheless, Chinese companies are still lagging behind in terms of immunotherapy development capacity compare to EU countries and the United States.  However, China's suitable immunotherapy application ground and its technically capable companies that are providing readily available solutions for China's bleeding wound, cancer, present an overall opportunity for the investors and, more importantly, patients.  Unfortunately, immunotherapy is not a silver bullet in cancer treatment since it still presents several side effects along with its limited efficacy in particular common cases. In spite of the challenges, the high unit price of immunotherapy drugs becomes an important engine to support the revenue stream of pharmaceutical enterprises within the cancer treatment market. Supported by the government, and scalable market capacity in China;  Chinese immunotherapy companies are expected to grow and provide very far-reaching benefits to the Chinese patients and their investors. Although their long-term hurdling will be challenging, they will find a market and the support from the third parties, as long as the scientists advocate immunotherapy.

News EO
May 8, 2019
report
News EO
May 8, 2019

I-Mab Tailors its Immunotherapy Products for China

Immunotherapy returned to the public with a positive attitude because of the attention and recognition of the Nobel Prize for Medicine in 2018; its public perspective in China was deeply influenced by the WEI Zexi (魏则西) incident. Immunotherapy, as its name implies, is the treatment of cancer by activating the original ability of T cells and the immune system to fight against cancer cells. Currently, the main therapies include immunological checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines. CAR-T cell therapy can transform human T cells to recognize tumour antigens and stimulate the immune system to remove cancer cells. Relevant research has entered the commercial market and its effectiveness has been constantly excavated.  As immunotherapy popularized and matures, I-Mab Biopharma (天境生物) thrives its business and moves closer to its IPO. I-Mab-Biopharma is a biopharmaceutical research and development company located in Shanghai, focusing on tumour treatment and autoimmune diseases. (Find more on the 2019 Technology Trends Report in China) Founded in 2016, I-Mab is valued at around half a billion USD from its latest series C financing of USD 220 million in June 2018. I-Mab has entered several R&D collaborations with clinical research institutes for developing novel immunotherapy. The company is at the dawn of its IPO. Other sizable and innovative Chinese startups are Shanghai Cell Therapy Group (上海细胞治疗集团  ) with USD 74 million and Jacobio Pharma (加科思 ) with USD 55 million total fundings. However, I-Mab is the biggest and the most immunotherapy focused company amongst them. The company's unique value proposition is its China tailored immunotherapy portfolio which will be commercialized after 2021.  China is the second biggest immunotherapy contributor globally by the number of institutional initiative; however, the country's cancer problem is much more severe than what is provided as a solution. I-Mab wants to position itself within this landscape.

News EO
Apr 8, 2019
News EO
Apr 8, 2019

I-Mab, Biodextris, BWH, and Nhwa Come into Immuno Collaboration

  Source from PR Newswire, Biodextris, Brigham and Women’s Hospital (BWH), I-Mab (天境生物), Jiangsu Nhwa Pharmaceutical (江苏恩华药业, Nhwa Pharma) signed the collaborative research agreement in Boston MA, U.S. on April 5th, 2019. The collaboration aims to develop a novel immuno-stimulatory therapy for neurological disorders. The cross-border collaboration includes two clinical research institutes, BWH and I-Mab, and two pharmaceutical companies, Biodextris and Nhwa Pharma. Researchers and clinicians at the Ann Romney Center for Neurologic Diseases at BWH will take the responsibility of biomarkers’ discoveries and validations, preclinical research, and early clinical studies. Biodextris, a Canada-based pharmaceutical company, will be responsible for CMC (chemistry, manufacturing, and controls) process for the novel therapy. Nhwa and I-Mab will provide financial, technical, regulatory, and other business support for the R&D, and even potential further commercialization. I-Mab is a biopharmaceutical startup founded in 2016, which was valued at USD 1.1 billion from its latest series C financing of USD 220 million in June 2018. I-Mab has entered several R&B collaborations with clinical research institutes for developing novel immunotherapy. The collaboration will study and use nasal immune modulator as an approach to treat certain neurologic disorders. Each party in the collaboration will use its advantages to accelerate the R&D process. BWH, a clinical research institute with a profound reputation and years of accumulated clinical research experience, will take the lead for research and analysis. Biodextris and Nhwa are experienced pharmaceutical manufacturers headquartered in Canada and China respectively. Nhwa is well-known in China for its CMC for neurologic therapeutics production and it is a Shenzhen Stock Exchange listed company. Yet, the lead of the research is BWH, and I-Mab plays a supportive role in the R&D process. BWH is a clinical research institute and able to conduct clinical trials relying on its solid foundation of research abilities and years of clinical trial experience, while I-Mab lacks the experience on this side. Though collaborated with several pharmaceutical companies and hospitals, I-Mab is still a young incomer in the healthcare area waiting to build its own reputation. The cross-border collaboration helps to lower the R&D costs and accelerated the process whether in clinical research status or potential commercialization stage. With experienced contractors’ participation, the new therapy’s materials have better support and can simultaneously approve for FDA and CFDA’s review when there is any progress.

Analysis EO
Jan 29, 2019
Analysis EO
Jan 29, 2019

I-Mab Biopharma's New CD47 Targeted Monoclonal Antibody Approved by FDA

Jan 29, 2019, /EqualOcean/ - I-Mab-Biopharma (天境生物), a biopharmaceutical research and development company located in Shanghai, focusing on tumor treatment and autoimmune diseases, announced its independently developed CD47 targeted human monoclonal antibody TJC4 was approved by the US Food and Drug Administration (FDA) for clinical research on January 25, 2019 (US Eastern Standard Time). TJC4 is the third drug approved by the FDA for clinical research within one month of application. The company claimed unlike other known CD47 targeted antibodies, TJC4 has a unique paratope, which is also called as a binding site, that binds itself to red blood cells to a minimum extent, also does not cause cell condensation, and no anemia symptoms occur during toxicology experiments using cynomolgus monkeys as samples. In addition, the antibody appears to be effective in both monotherapy and combination therapy in animal models of hematologic malignancies and solid tumor malignancies. Dr. SHEN Huaqiong (申华琼), president of I-Mab Biopharma's R&D center said: "US FDA's approval for clinical research of TJC4 has significant meaning for further global research and development of I-Mab Biopharma's drug candidate." He also stated that "We believe TJC4's safety feature reflected in toxicology studies is a key advantage against other CD47 targeted antibodies also under development globally. TJC4 also unveils the possible optimizations in future tumor treatments.” I-Mab Biopharma received 4 rounds of financing after its incubation since 2016, receiving more than USD 380,000,000 altogether. It also took Tasgen (天视珍生物) in March 2017, which is a company focusing on autoimmune diseases previously. According to ITJUZI.com, the company was backed by big investors like Hillhouse Capital (高瓴资本) and CDH Hund (鼎晖资本), who had history of extensively investing on healthcare companies in the past. More efforts to be made after approval Following the approval of the clinical trial, I-Mab Biopharma will fully launch the 1/1b clinical trial to assess the safety and explore the dosage, as well as to observe the effectiveness of TJC4 antibodies in patients with solid and lymphoma tumors in both monotherapy and combination therapy. This phase of research typically would last for several months, in which normally 20 to 100 healthy volunteers or people with the condition will be involved. About 70% of the drug candidates undergoing these research would be able to move to the next phase of the clinical trial. It is expected that by the second quarter of 2019, I-Mab Biopharma will be able to launch several clinical trial sites in the United States. According to FDA's regulations, in order to launch the selling of the drugs developed, pharmaceutical companies need to fill a marketing application after the clinical trial ends, in which the drug developer must have "adequate data" from two large, controlled clinical trials. So that, opening more clinical trial sites would help the company to get more accurate data; multiple trials would also reveal more possible issues in terms of side effects and adverse reactions of the drug being examined, which aids the company to react prior to the final FDA review to prevent and improve the drug's effectiveness.   The "Trial" has just begun This is indeed an important step for I-Mab Biopharma to bring innovative drugs of high potential to patients around the world, nevertheless, this is also only the third step of the entire FDA drug approval phase, which includes 5 steps altogether. Except the last step, Post-market safety monitoring, the clinical research as well as the 4th step of FDA Review together could last for more than 4 years. The FDA Review stage alone needs 6-10 months for them to conduct complicated reviews and examine the report based on the developer's trial data. FDA sometimes also requires the developer to address questions based on trial data or even requires additional studies. This is not an easy journey to go through. After all, only 6.93% of all the drug candidates under review by FDA can end up in the market eventually. A market full of beginners According to PMGroup's research, CD47 is recognized as a hot research area by many Chinese biopharmaceutical companies recently, there are only a few CD47 developing programs under initial testing stages outside of China. ThermoFisher Scientific and abcam are offering a series of antibodies including monoclonal and polyclonal ones, but all are still for research use only. Also, Stanford University spinout Forty Seven leads in the R&D of CD47-targeting antibody and has already attracted attention from pharmaceutical giants like Merck KGaA and Roche, but still under clinical trial, and it may still need quite a few years for it to be seen in pharmacies. Apart from these, some biopharmaceutical companies are also developing CD47-targeting antibodies but are still at very initial stages, including Canada's Trillium Therapeutics, US biotechs Arch Oncology, Aurigene, and Synthon of the Netherlands. What's worthwhile to be mentioned is Innovent (信达生物制药), a Chinese competitor for I-Mab Biopharma, who went to IPO in October last year; Its CD47-targeting antibodies were approved by FDA in the same month, and also claimed to have stronger receptor blocking ability than other antibodies under scrutinization against CD47. This claim somewhat resembles the ones made by I-Mab Biopharma. Studies have also suggested that blocking of CD47 can send some tumor cells into programmed cell death, therefore, to secure the healthy cells from infected tumor cells seem to be extremely important for tumor treatment. Not only these two companies, but many other biopharmaceutical companies in the future will also pay much attention on this field. The blocking ability of antibodies will also go through a series of upgrade and improvement, which requires continuous R&D for biopharmaceutical companies. In a word, the battle between biopharmaceutical companies in finding the best monoclonal antibodies in cancer treatment is still at its infancy, and the ultimate cure for cancer still awaits far ahead.  

News EO
Dec 5, 2018
News EO
Dec 5, 2018

I-Mab and TRACON Become Strategic Partners for Immuno-Oncology Programs

I-Mab and TRACON Become Strategic Partners for Immuno-Oncology Programs On 29 November 2018, I-Mab Biopharma (I-Mab) and TRACON Pharmaceuticals announced strategic partnerships for multiple immuno-oncology programs. I-Mab, founded in 2016, is a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases. I-Mab R&D team is led by ZANG Jingwu (臧敬五), a venerable biopharmaceutical scientist that has published papers as the first author on Science and Lancet. Under his leading, I-Mab is under developing biologics in immune-oncology and autoimmune areas. After raising USD 220 million in series C, I-Mab is well-recognized by the capital market. By far, 30% of the global medicine costs is generated in Asia, and the percentage will increase corresponding to regional healthcare service development. According to WHO’s prediction, the oncological therapy market size will reach USD 150 billion in 2020, which is 40% more than the data in 2015. The increased size is essentially contributed by the ascending number of cancer patients in China and India. In China, 4 million patients will be diagnosed with cancer annually. The uprising demand for cancer therapy pushes the R&D progress of biopharmaceutics companies. TRACON and I-Mab’s cooperation follows the market trend and with funding from both sides, the immuno-oncology programs seem to be a win-win for both China and the US’s tumor patients and biopharmaceutics industry. Biopharmaceutics are among the most sophisticated achievements in modern science. The complex and huge structure of drugs invented with improvements in lowered side effects and high efficacy. One of I-Mab’s series B’s investor, Tasly Pharma(天士力) is a Chinese pharmaceutical company listed in Hongkong Exchange with a market value of nearly USD 2 billion. Indeed, China’s pharmaceutical market size is expanding. The investment in new drug R&D increases and is yet to satisfy the market. The sophistication of biopharmaceuticals costs accordingly, and the torsion between drug price and drug costs never goes easy. The demand of affordability is a paradox to for move biopharma from the scientific front line into the business mainstream.

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