Deals and Financings

SinoMab Bioscience, a Hong Kong clinical-stage antibody company, reported its filing for a Hong Kong IPO has been accepted by the Exchange (see story). Founded in 2001 by Dr. Shawn Leung, the company has two mAbs in clinical development against targets for autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus,) and cancer (non-Hodgkin’s lymphoma). It has another four mAbs in pre-clinical development. SinoMab claims particular expertise in hybridization technology for mAbs. Headquartered in Hong Kong, SinoMab has additional facilities in Shenzhen, Hainan and Suzhou.

I-Mab Biopharma, a Shanghai oncology company, in-licensed greater China rights to a novel immunotherapy developed by MacroGenics (NSDQ: MGNX) of Maryland (see story). The candidate, enoblituzumab, is an investigational B7-H3 antibody. A member of the family of B7 immune regulator proteins, B7-H3 is expressed by several types of tumors. I-Mab agreed to a $150 million package of upfront and milestone payments, plus royalties. It will lead greater China trials of the candidate and also participate in MacroGenics global tests, currently testing enoblituzumab in patients with head and neck cancer.

Miaoshou Doctor, an online/offline healthcare company headquartered in Beijing, completed a $72.8 million Series C+ financing round, led by Starquest Capital and including Sequoia Capital China along with other investors (see story). Although the round was completed in January, it is now known that the round was priced at a better than $1 billion Unicorn valuation for Miaoshou. The company offers a chain of offline pharmacies, online links between doctors and patients, online healthcare consultation and O2O services. In the previous C round one year ago, Miaoshou raised $79.3 million, led by Tencent.

Shanghai Fosun Pharma (SHA: 600196; HK: 2196) paid $36 million to buy an older GlaxoSmithKline (NYSE: GSK) drug making facility in Suzhou, along with non-exclusive rights to manufacture lamivudine, a GSK treatment for hepatitis B/HIV (see story). Last week, GSK officially opened a new $95 million Singapore facility that uses an enzyme-based continuous manufacturing process. The process is less expensive and more friendly to the environment than traditional chemical synthesis. Initially, GSK's new facility will produce Daprodustat, an oral treatment for anemia associated with chronic kidney disease.

Company News

Novartis (NYSE: NVS) expects to submit 50 new drug applications in China between 2019 and 2023 -- ten per year -- according to John Tsai, head of global drug development and chief medical officer for Novartis (see story). The new drugs will target major diseases in China, he said, as he praised China's greatly speeded up regulatory reviews, which now offer timelines similar to the US and EU. "In light of the governmental regulatory reforms, we are working to have every pivotal drug development program include China from the beginning by default," said Tsai.

Gilead Sciences (NSDQ: GILD) signed a strategic cooperation agreement with Chengdu Hi-tech Zone to develop a Western China Operation Center at the Chengdu park (see story). Gilead is known for developing drugs for difficult-to-treat infections, especially HIV/AIDS and hepatitis C. Its first China approval came in 2017 for the hepatitis C treatment Solvadi. In China, Gilead opened a Shanghai commercial office in 2016. Currently, Gilead is conducting clinical trials of sofosbuvir/velpatasvir, the company's single-tablet treatment for HCV, at sites across China.

Trials and Approvals

CStone Pharma (HK: 2616) of Suzhou has dosed the first patient in a China clinical trial of avapritinib as a treatment for gastrointestinal stromal tumors (GIST) (see story). One year ago, CStone acquired China rights to the candidate from Blueprint Medicines of Boston in a three-drug deal worth up to $386 million. CStone is conducting a Phase I/III bridging trial that will be part of Blueprint's global Phase III trial of avapritinib as a third/fourth line treatment for GIST, compared to Bayer's Stivarga®.

BeiGene (NSDQ: BGNE; HKEX: 06160) of Beijing has been granted priority review by the NMPA for tislelizumab, the company's PD-1 immunotherapy, as a treatment for urothelial carcinoma (UC), the most common form of bladder cancer (see story). It is the second indication to receive priority review. In November 2018, the NMPA agreed to review the candidate under priority rules for relapsed/refractory (R/R) classic Hodgkin’s lymphoma (cHL). BeiGene said it is testing tislelizumab in 13 pivotal or potentially registration-enabling trials.

Disclosure: none.