BGI Genomics

Nucleic Acid Testing Accelerates, BGI Genomics Shares up 92.95% This Year

BGI Genomics Benefits from Overseas Epidemic, Buying Financial Services with Cash While Raising CNY 500 million in debt

BGI Genomics's BRCA1/2 Gene Mutation Detection Kit Passes Approval for Innovative Medical Devices by SFDA

BGI Genomics to Repurchase Shares with CNY 300 to 600 million

BGI Genomics saw its stock price fell 3.3% to CNY 101.44 dramatically.

Announcement of BGI Genomics on the change of medical device registration certificate of the wholly-owned subsidiary.

Chinese self-developed kits are constantly making breakthroughs and quickly winning orders from multiple countries

BGI: a head-on battle with novel coronavirus at an anti-virus outpost

BGI Genomics: Chinese Diagnostics Outs to ‘Western Sea’

On March 2, BGI announced that the Danish Medicines Agency authorized its wholly Danish-owned and -based subsidiary (BGI Europe A/S) with a Free Sales Certificate. The subsidiary can trade freely for two years across the European Economic Area (EEA), and other countries that recognize CE (Conformité Européene) mark – if without Mutual Recognition Agreements (MRA). This approval grants a two-year permit for its diagnostics business in over 31 countries in Europe.  The Shenzhen-based biotechnology became the first Chinese biotechnology company to receive the Free Sales Certificate (FSC), especially amid the current situation of coronavirus. Specifically, BGI’s Denmark-based subsidiary can provide 19-nCoV diagnostic kits, along with technical support and clinical experiences, to medical institutions and research labs tagged with EU standards. The target product, real-time fluorescent RT-PCR kit for detecting 2019-nCoV, has become the primary diagnostic device across China, helping to ease the pressure on medical services. In the shadow of the continued spread of coronavirus, the situation in Europe escalated in the past week. As of March 4, the most severely affected European country – Italy – reported a total of 2502 infected cases, followed by its neighboring France (212 cases) and Germany (196 cases). The European health ministers raised the threat level to critical, faced with insufficient medical facilities and burgeoning infection rates. Beyond Europe, what worries international communities is the potential catastrophic outbreak in Africa and other developing countries with nascent medical infrastructures. The rising tension over the coronavirus in Europe and Africa indicates an urgent and tremendous need for medical supplies for doctors in the frontline. Fast, effective diagnosis is the core step in identifying infected cases and taking proper measures accordingly. “At this time, there are no reports of significant supply issues regarding medicines or medical equipment as a result of the virus outbreak,” the Danish Medicines Agency stated on February 24, “however, it is possible that such supply issues may arise at a later date.” The European Free Sales Certificate (FSC) is an approval document issued by any EU Competent Authorities (CAs) for exporting to other markets outside of the European Economic Area – mostly some African and South American countries, such as Egypt, Saudi Arabia, Tukey, Brazil, Thailand, India and Nigeria. This certificate is only open for EU-based companies, including manufactures, EU-located representatives, and OEM producers (original equipment manufacturer).  BGI Europe A/S plays a role in sales, procurement and financing, as part of BGI Genomics’ international strategy. Unlike other overseas affiliates (the Netherlands, the US, Canada, Australia, and Japan), it is the only direct-invested subsidiary, acting with the parent’s full will and wholly merged into the group’s report. Earlier in February, BGI’s detection kit was certified with the CE mark, indicating its free sales in the EU zone. Now with the Certificate, the packages have smoother access to a tremendous market. Since the outbreak of the coronavirus, BGI Genomics has raced to develop and improve the detection technique, with the fluorescent RT-PCR (reverse transcription-polymerase chain reaction) kits and auto-detection Huo-Yan labs, as introduced in a previous EqualOcean analysis. The Shenzhen-based bio-company also donated some kits to satisfy Japan’s urgent need. Becoming the flagship medical supplier in the epidemic has positively impacted BGI’s performance. After selling shares on the public market in 2017, BGI faced a drop in net income the following year due to substantial R&D investment. Crowned by the EU-granted CE mark and Free Sales Certificate, the company saw a 7.6% price jump when opening its announcement day (March 2).

BGI deploys coronavirus diagnostic labs in Wuhan

Intel and Lenovo join forces with BGI to accelerate genome analysis of the new Coronavirus

COVID-19 Nucleic Acid Detection Kit Receives EU Free Sale Certificate

Restarting Office Hour: BGI Genomics Helps China Resume Work

As the disease outbreak is being stabilized, many companies are recovering daily operations and production nationwide. BGI Genomics (300676: SH), as the manufacturer of Covid-19 diagnostic kits, not only offers a free test service for its employees before allowing them to return to the office but also provides a one-stop Covid-19 examination plan for enterprises. Since its diagnostic products were approved by the National Medical Products Administration (NMPA), the Shenzhen-based bio-company completed 215 thousand coronavirus tests as of February 24. As the authorized institution for detecting this virus, BGI Genomics helped facilitate the upgrading of the diagnostic process from the initial 16 hours to three hours, by its real-time fluorescent RT-PCR (reverse transcription-polymerase chain reaction) technology In the race of diagnostics distribution To detect the virus, the nucleic diagnosis, compared to protein diagnosis, can be developed within a shorter time at a lower cost. This nuclei-based method first extracts the RNA from the patient sample, and lets it go through RT-PCR before enlarging and signaling the virus information attached to the sample. BGI’s one-stop checkup plan for business introduces two sampling methods: on-door sampling service and self-sampling, both non-invasive and no-blood. On its WeChat account, it published a short video to explain the detailed procedure in the case of self-sampling within just five steps. According to Nature Biotechnology, there are 13 selected diagnostic tests for Covid-19 across China, U.S. and Europe (mostly Germany), with 10 available listed below . These test developers include national research labs and commercial entities at different stage, with six from China’s mainland and Hong Kong region. Compared to the mature application of assays in China, kit providers in the U.S. are either applying for the FDA’s approval (such as Novacyt Primerdesign), or only for research use (Biomeme or Thermo Fisher Scientific) Huo-Yan Laboratory: the key to diagnosis Huo-Yan Laboratory is a diagnosis lab named after the Golden Eyes of Sun Wukong (from ancient Chinese literature, the Journey to the West). In the frontline of the epidemic, it plays a crucial role in discerning suspect cases, aligning with other strategic establishments, such as Leishenshan (Thunder God Mountain) and Huoshenshan (Fire God Mountain) hospitals and mobile cabin hospitals. This laboratory is equipped with BGI’s automatic machine for sample preparation, which can complete the extraction task without manual work within one hour. Since the launch on February 5, Huo-Yan Laboratory (Hubei) has received a provincial-level total of 57 thousand patient’s samples as of February 24.  From the central city of the outbreak, Wuhan, BGI has deployed such labs in the other five capitals and taken full charge of sample examination. So far, BGI has been examining over 50 thousand case samples per day if counting all these labs; it can raise daily capacity to 80 thousand. Medical assurance: a new demand at scale As it comes to the end of the extended Spring Festival vacation, an increasing number of employees are busy returning to their work city. But it does not mean that the whole of society has surpassed the tension stage.  On February 19, an employee at DangDang, the once-public e-commerce based in Beijing, was diagnosed positive for Covid-19 and other 66 colleagues asked to do home-quarantine. More similar cases occurred after the workers resumed regular office schedules without a strict examination in advance. According to the national guidelines on orderly recovering production, the manufacturing industry is prioritized due to its wide supply chain and substantial economic influences. As of 21 February, China reached an overall 70% resumption rate in manufacturing. With such a tremendous amount of population movement, all cities urge enterprises to take as many precautions as possible to prevent potential virus-carriers from spreading the illness.  BGI, as the first recognized kit provider by the Chinese FDA (Food and Drug Administration), is actively taking this niche market by providing diagnosis services in a flexible form. The value created is more than a test result of employees with credit from a third-party, but also facilitates resuming regular daily operation and gaining time advantages on a strategic phase. Cross-border assistance Since the approval of the kits, this biotech has started to produce the nucleic kits at full capacity for immediate use. The first batch of 100 thousand kits was sent to the most severe area, Hubei Province, followed by 200 thousand to outbound. On February 20, BGI Genomics, together with Mammoth Foundation, sent loads of diagnostic kits to Japan’s National Institute of Infectious Disease. Since the RT-PCT kits are handy and efficient on the frontline, the company has supplied to over 26 countries and regions.  Since the outbreak, the market witnessed BGI’s share price soar to a history-high CNY 90.73 on February 5, at a two-day growth of 3.75% before a 15% slump to CNY 76.77 later. Now the share is priced at CNY 82.85 as of today, showing signs of a move upward.

Brief report on 2019 annual performance

Test results in 3 hours! BGI develops new coronavirus kit