Deals and Financings

Shenzhen's Chi-Next Exchange rejected the latest IPO proposal from BGI, China's giant genomic sequencing company (see story). The problem? Insufficient documentation, according to a report from ChinaMoneyNetwork.com. In December 2015, BGI submitted an application to IPO two of its merged divisions: BGI Dx (pre-natal genomic testing) and BGI Tech (contract sequencing). The company hoped to raise $260 million at a valuation of $3 billion. 

TaiGen Biotech (TWO: 4157) formed a $102 million JV with YiChang HEC ChangJiang Pharma (HK: 1558) to develop a dual-drug, oral direct-acting antiviral treatment for chronic hepatitis C (see story). Each company will contribute their clinical stage antivirals to the Taiwan-China JV, a first cross-straits JV according to the companies. TaiGen will put in China rights to furaprevir (TG-2349) for a 49% stake in the JV. HEC will transfer China rights for yimitasvir (DAG-181), plus an undisclosed amount of cash, to the JV for 51% ownership. 

Decheng Capital, a Shanghai-San Francisco life science investor, led a $12 million Series A investment in Cirina (see story). Cirina is a two-year old South San Francisco company developing blood-plasma tests for early detection of cancer. The company is based on the work of co-founder Dennis Lo, DM, DPhil, a plasma nucleic acid scientist who discovered the presence of fetal DNA in a pregnant mother’s blood-plasma. Cirina has now named Maneesh Jain, PhD, as CEO and is filling out its leadership team. 

DiaCarta, a San Francisco-Nanjing molecular diagnostics company, received a $300,000 grant from the National Cancer Institute to validate its RadTox QuantiDNATM product as a test for monitoring radiation response in cancer patients (see story). Currently, no reliable methodology exists for assessing a patient's response to radiotherapy. The QuantiDNATM will be used to monitor circulating free DNA (cfDNA), a patented DNA biomarker, directly from patient plasma during radiation therapy. In 2014, DiaCarta raised $8 million in a Series A Round funding from BVCF (BioVeda China). 

Medbanks, a Beijing oncology big data company, announced a strategic partnership with IMS Health (see story). In the collaboration, the two companies will establish and commercialize Medbanks' oncology-focused clinical database in China. Medbanks explained that cancer care, because of its complex and personalized nature, would be well served with a high-quality, structured clinical database, directed toward a China population. The information will guide clinical decision as well as research into novel drugs, improving outcomes. 

Fosun Pharma (SHA: 600196; HK: 02196) has acquired China rights to an anti-MET monoclonal antibody developed by Kolltan Pharma, a clinical stage New Haven, Connecticut biotech (see story). In preclinical studies, KTN0216 is being tested against neuroblastoma, a form of brain cancer. Kolltan expects KTN0216 will prove to be effective against HGF-dependent and MET-amplified tumors. According to Kolltan's website, KTN0216 is about to begin IND-enabling studies. Financial details of the agreement were not disclosed. 

Xbrane Biopharma, a Swedish company, signed a non-binding term sheet with an unnamed China pharma for China distribution of Spherotide, a long-acting generic form of Decapeptyl®, a cancer drug (see story). The unnamed China pharma will pay $1.9 million on signing and make three additional milestone payments to bring the total to $7.6 million. Xbrane describes the China pharma as a large company that is active in all sectors of China's pharma market. Xbrane will manufacture the drug, but the China company will be responsible for all clinical trials. Launch is expected in 2021. 

Company News

Merck KGaA (XE: MRK) of Germany officially opened its new $189 million China pharmaceutical plant in Nantong and announced another $89 million investment in a nearby Life Science center (see story). The Nantong facility will produce drugs for China's Essential Drug List while the new Life Science Center will manufacture high-purity inorganic salts, cell culture media products as well as ready-to-use media for drug discovery and production. Merck said the plants will help transform Merck from an importing company to a local China pharma. 

Trials and Approvals

Pfizer (NYSE: PFE) received CFDA approval to market Prevenar 13®, a pneumococcal 13-valent conjugate vaccine, in China (see story). The vaccine immunizes children (six weeks to 15 months) against invasive diseases (bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by 13 serotypes of pneumonia. In April 2015, the CFDA refused to approve an update of Pfizer's marketing application for an earlier form of the vaccine, Prevenar 7, the only vaccine Pfizer marketed in China. In response, Pfizer closed its China commercial vaccine operation, laying off 200 workers. 

Suzhou Alphamab will start a China Phase I trial for KN015, a biologic treatment for infertility (see story). It is the first of Alphamab's novel biologic/biosimilar programs to reach the clinic. KN015 is a long-acting human follicle-stimulating hormone (FSH), used as part of an assisted reproductive therapy to develop multiple follicles in women. Unlike other currently available programs, KN015 is expected to require only a single injection, rather than daily injections, because of its enhanced half-life. 

Government and Regulatory

Starting in January 2017, the CFDA will begin accepting priority review applications for medical devices, a parallel effort to the priority reviews established for new drugs (see story). To qualify, the medical device must offer a significant advance in terms of clinical practice or be derived from a National Science and Technology Major Project or National Key Research and Development Plan. The priority pathway is open to Class III domestically manufactured devices and Class II or III imported devices. 

Disclosure: none.