Shanghai Industrial Investment, a state-owned conglomerate, plans to launch a $7.3 billion equity fund for China biopharma investments (see story). The company plans to begin raising $1.5 billion in January for the fund's first tranche. Few details about the fund are available; its existence is known only because Jun Zhou, CEO and chairman of Shanghai Industrial, announced the fund at the ninth State-Owned Assets Summit in Shanghai. Shanghai Industrial Holding (HK: 363), the parent organization, is majority owned by the Shanghai Municipal Government.  

Shanghai Junshi Biosciences (HK: 1877) rose 22% in its first trading session on the Hong Kong Exchange following its $394 million IPO (see story). Last week, Junshi announced its lead drug candidate, Tuoyi (toripalimab), an anti-PD-1 molecule, was approved by China's NMPA as a second-line treatment for melanoma. It is the first domestic PD-1 approved in China. Junshi has 13 products in development, five of them clinical stage. The IPO was completed at a nearly $2 billion valuation, and the company now has a market capitalization of $2.4 billion.  

Crystal Pharmatech, a Suzhou-New Jersey materials science CRO that focuses on solid state information for APIs and formulations, raised $14.5 million in venture capital (see story). The CRO develops crystallization processes for drug manufacturing. Three years ago, Crystal completed a $10 million A round. Founded in 2010, Crystal, which has business relationships with over 300 pharmas, is headquartered in Suzhou'sBioBay Park, with business offices and a lab in New Jersey.  

Venus Medtech, a Hangzhou medical device maker, closed its merger with Keystone Heart, a private Israeli-US company that makes TriGuard 3™, a cerebral embolic protection device (see story). In 2017, Venus acquired China rights to use the TriGuard to protect against cerebral embolisms during use of Venus' own transaortic valve replacement product, the first TAVR approved in China. The Keystone device is designed to protect all brain regions in patients undergoing cardiac procedures. Terms of the agreement were not disclosed.  

Government and Regulatory 

FibroGen (Nasdaq: FGEN), a US-China novel drug company, and AstraZeneca (NYSE: AZN) announced China approval of their partnered drug for anemia, the first time an international novel drug was approved initially in China (see story). Roxadustat is a first-in-class product approved for patients with chronic kidney disease who are on dialysis. Roxadustat was approved under China priority rules that allow rolling submissions and promise a ruling six months after the submissions are complete. The approval marks a significant step toward meeting China's goal of streamlining drug approvals for novel drugs.  

Trials and Approvals 

Innovent Biologics (HK: 01801) and Eli Lilly (NYSE: LLY) announced their co-developed PD-1 immunotherapy was approved in China as a third-line treatment for patients with classical Hodgkin's lymphoma (see story). Tyvyt® (sintilimab) is the second China-developed anti-PD-1 mAb to be awarded marketing authorization, following Junshi's Tuoyi last week. In 2015, Innovent formed a $1 billion partnership with Lilly for multiple drug candidates including three anti-PD-1 based bispecific antibodies. Tyvyt is the first approval from that portfolio.  

Bio-Thera, a Guangzhou clinical-stage biopharma, filed a China IND for its anti-Trop2 antibody drug conjugate, BAT8003 (see story). Bio-Thera intends to test the ADC as a treatment for Trop2-positive cancers, including triple-negative breast cancer and gastric cancer. Bio-Thera is developing a pipeline of innovative therapies, including immunotherapies, along with biosimilars for China use. At the moment, the company has three biosimilars and one ADC in late-stage trials, plus four candidates in early clinical-stage development.  

Xynomic, a clinical stage Delaware-Shanghai pharma, has filed three China INDs for its lead candidate, abexinostat, a novel HDAC inhibitor (see story). The potentially pivotal trials will test abexinostat, a China Category 1 drug, against renal cell carcinoma and lymphoma. Abexinostat is already in a global Phase III trial, paired with pazopanib, as a first- or second-line therapy for metastatic renal cell carcinoma. Xynonic is an in-licensing company that is developing drugs for China and the US.