Weekly Top 5 in China (0310-0316)

Natera and BGI Genomics Announced Partnership to Commercialize Molecular Diagnostics in China

The molecular diagnostics markets in China are rapidly growing, which driven by the rising incidence of cancer and infectious diseases. Natera, Inc., a global leader in cell-free DNA genetic testing, and BGI Genomics Co., Ltd., the largest cell-free DNA clinical testing laboratory in China, announced a $50 million partnership to commercialize Natera’s Signatera™ minimal residual disease (MRD) test in China, and to develop reproductive health tests in select markets, using DNBseq™ NGS technology platform, BGI’s proprietary sequencing technology.

As soon as Natera and BGI Genomics received China’s regulatory approval for the use of Signatera test on DNBseq™ technology platform, Signatera MRD and molecular monitoring test will be offered in China. This partnership will accelerate Natera’s entry into the large and growing oncology market.

About BGI

BGI Genomics is an independent division of BGI Group; the goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry’s broadest array of leading technologies. BGI Genomics also offers a wide portfolio of genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare.

About Natera

Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of diseases worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in California. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including the biopharmaceutical companies, and genetic laboratories through its cloud-based software platform.

Grifols Acquires $1.9 Billion Stake in Shanghai RAAS

In China, with supplies limited by strict rules governing blood donation, the demand for human serum albumin, a blood-plasma derivative used to treat liver diseases is rising. China is one of the fastest growing markets for plasma products and an important market for nucleic acid test (NAT) technology.

Grifols, a Spanish multinational pharmaceutical and chemical manufacturer, acquired 26.2% stake in Shanghai RAAS, one of China’s largest blood plasma companies, for $1.9 billion. This contract will make Grifols the second largest shareholder in RAAS. As part of the agreement, Shanghai RAAS will become exclusive distributor of Grifols’ plasma-based and diagnostic products in China, including Grifols’ NAT systems used to screen plasma donors for HIV and HCV. Under the strategic alliance agreement, the two companies will manufacture, market and develop plasma products and transfusion diagnostic solutions for China’s market.

About Grifols

Grifols, founded in 1940 and is headquartered in Barcelona, Spain, is a specialty pharmaceutical company, which develops, manufactures, and distributes biological medicines on plasma derived proteins internationally. The company operates through five segments: Bioscience, Diagnostic, Hospital, Bio Supplies, and Others. The company serves hospitals and clinics, group purchasing organizations, governments, and other distributors through sales representatives, marketing partners, and third-party distributors.

Ambrx and BeiGene Collaborate to Develop Next-Generation Biologics

Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of innovative protein therapeutics, and BeiGene, Ltd., a commercial stage biopharmaceutical company focused on developing and commercializing innovative immuno-oncology drugs for the treatment of cancer, have announced a global research and development collaboration.

Ambrx’s proprietary Genetic Code platforms enable site-specific modification of proteins to create potentially best-in-class innovative protein drugs. The core of this technology is the efficient incorporation of non-natural amino acids into proteins in both E. Coli (ReCODETM) and CHO cells (EuCODETM).

The collaboration leverages Ambrx’s clinically validated drug discovery technology platforms with BeiGene’s expertise and resources to pursue the development and commercialization of next-generation biologics drugs.
Under the terms of the agreement, Ambrx will receive a payment of $10 million to fund the initial discovery, research activities and additional upfront payments of up to $19 million if BeiGene elects to initiate additional programs.

Ambrx is eligible to receive potential development, regulatory, and sales-based milestone payments up to a total of $446 million, in addition to royalties on future global sales. BeiGene will have worldwide rights to develop and commercialize all drug products resulting from the collaboration.

About Ambrx

Ambrx Inc. is a clinical stage biopharmaceutical company using an expanded genetic code to create first- and/or best-in-class biotherapeutics, including antibody drug conjugates (ADC), immunomodulating proteins, bispecific antibodies and other therapeutic proteins with improved pharmacologic properties.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States, Australia and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer.

Novo Nordisk Launches Innovation Platform

According to the annual government work report released in the National People’s Congress earlier this month, outpatient medicines for treating high blood pressure and diabetes has become reimbursable items under the medical insurance scheme.

Novo Nordisk, one of the world’s largest maker of diabetes drugs, announced the launch of an innovation platform called INNOVO. INNOVO is expected to accelerate the transformation of scientific research into innovative drug discovery and development. Novo Nordisk will accordingly join hands with Chinese local academic institutions, bio-tech startups and incubators, to build an open, integrated, efficient and collaborative research and development ecosystem. Novo Nordisk plans to incubate three to five mature projects through the program, aiming to result in new drug pipelines in the next three to five years.

About Novo Nordisk

Novo Nordisk is a healthcare company, founded in 1925 and headquartered in Bagsvaerd, Denmark. The company engages in the development, manufacture, and marketing of pharmaceutical products worldwide. It operates in two segments, Diabetes Care and Obesity, and Biopharmaceuticals. The Diabetes Care and Obesity segment provides products in the areas of insulins, GLP-1 and related delivery systems, oral anti-diabetic products, obesity, and other chronic diseases. The Biopharmaceuticals segment offers products in the areas of haemophilia, growth disorders, and hormone replacement therapy.

Nanjing King-Friend’s Anticoagulant Medication Enters the UK market

Enoxaparin sodium injection is mainly used for the treatment of anticoagulant, antithrombotic and other symptoms, and the prevention and treatment of thrombosis or embolic diseases, such as myocardial infarction, thrombophlebitis, pulmonary embolism, etc.

Nanjing King-Friend (NKF) Biochemical Pharmaceutical Co., Ltd., one of the earliest pharmaceutical companies engaged in the extraction and purification of heparin and the development of heparin-based mucopolysaccharide structure, recently received a marketing approval (MA) for enoxaparin sodium injection issued by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. A total of five specifications were approved.

The application for the injection in the EU is a DCP (DeCentralized Procedure) process, which has now completed the technical review and entered the issuance process for the listing approval of each applicant country. NKF said that enoxaparin sodium injection was approved by the major European countries, indicating that the company has been qualified to sell the drug in the EU market. The European registered agent for enoxaparin injection is Venipharm SAS, which plans to begin commercial sales in the EU countries in the second half of 2019, and is expected to have a positive impact on NKF.

About Nanjing King-Friend

Nanjing King-Friend (NKF) Biochemical Pharmaceutical Co., Ltd. is located in Nanjing, China, and was founded in 2000. NKF is one of the earliest pharmaceutical companies engaged in the extraction and purification of heparin and the development of heparin-based mucopolysaccharide structure. NKF has been producing heparin products for more than 20 years.

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GeneOnline