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News Jun 21, 2019 04:25 pm EqualOcean

Jacobiopharma inhibitors make significant progress

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Nov 12, 2019 06:02 pm ·

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.

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Oct 19, 2019 02:10 pm ·

'The Great Globalization Forward' Continues in CRO Scene: dMed Secures New Round

So far, 2019 was a lucrative year for the third party researchers in the pharmaceutical industry of China. On October 16, yet another Chinese Contract Research Organization (CRO), dMed Biopharmaceutical (缔脉生物), announced the completion of a nearly USD 50 million Series B financing, led by healthcare-focused investor Vivo Capital (维梧资本). Legend Capital (君联资本), Lilly Asia Ventures (礼来亚洲基金) and the company's former investor Qiming Venture Partners (启明创投) joined in this round as well. The company claimed to improve its research facilities and its global capacity in clinical development and product registration using the new capital injection.  This round was not the first time that the Shanghai-based CRO ramped up its globalization efforts. The company had previously announced a partnership with a Manhattan-based CRO, Target Health, to help Western and Chinese biopharma and medical device companies capitalize on the rapid internationalization of clinical trials between the US and China. But why globalization matters for Chinese CROs? China Food and Drug Administration (CFDA), now under the National Medical Products Administration (NMPA) has made substantial changes in drug developing and distribution policies over the last three years. At the end of 2017, NMPA drafted a series of regulations, easing multinational drug developers' clinical trial applications in the mainland; and in the September of 2018, the Chinese regulators further facilitated the import of clinical data for the multinational drug developers into the mainland, bringing about new landing possibilities for the foreign novel drugmakers in Chinese market.  In 2018, global spending on pharmaceutical research and development was around USD 172 billion and set to be over USD 204 billion by the end of 2024. Globally, USD 37 billion flew into CROs in 2018 with a growth rate of around 8%. USD 9.6  billion was spent in CRO related operations in China in 2018, Forward reported. Qiming Venture, a Chinese TMT and Healthcare focused PE investment firm, extended its healthcare portfolio with another CRO by this investment. The VC had an extensive healthcare portfolio covering emerging companies from the biopharmaceutical industry, from the EO500 member novel drugmaker Jacobio (加科思) to the Tencent's new generation clinic WeDoctor (微医). The VC claims to have invested in nearly 90 start-ups in the healthcare sector, mainly focusing on the "AI-related smart 'healthcare industry', making Qiming VC one of the most assertive healthcare investors of China.

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Sep 19, 2019 02:11 pm ·

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. 

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May 15, 2019 02:34 pm ·

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.

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