Deals and Financings
Shanghai Fosun Pharma (HK: 02196: SHA: 600196) announced it will seek a Hong Kong IPO for Shanghai Henlius Biotech, its monoclonal antibody JV subsidiary. At the same time, the company will withdraw its application for a listing on China's Third Board, the National Equities Exchange and Quotations System. Founded in 2010, Henlius is a joint venture between Fosun Pharma and US-based Henlius; Fosun owns 60% of the JV. The company was established to develop mAb biosimilar drugs, bio-betters and novel mAbs.
GO Therapeutics of Cambridge, Mass., signed a $195 million licensing deal with Roche (SWX: ROG) (OTCQX:RHHBY) to develop antibodies for cancer. One year ago, Shenzhen Salubris (SHZ: 2294) made a $5 million investment in GO, acquiring China rights to GO's future products as part of the deal. GO uses advances in glycobiology to develop cancer drugs that it hopes will prove to be more potent and less toxic. The pre-clinical company develops cancer-specific antibodies that can be used as antibody-drug conjugates, bispecific T-cell engagers and immune-based cell therapies.
Aohua Endoscopy Co., a Shanghai endoscopy device maker, raised $44 million in a D round led by Lyfe Capital, a Shanghai healthcare-focused PE firm, and joined by existing investors Legend and Qiming. The company said the capital will be used to develop a new generation of endoscopic systems and build a global service network. Founded in 1994, Aohua's sales network reaches more than 80 countries in the world.
HiFiBiO Therapeutics, a US-France-China biopharma, will collaborate with Kite Pharma, a division of Gilead Sciences (NASDAQ:GILD), to develop technology that supports the discovery of neoantigen-reactive T cell receptors (TCRs) to treat various cancers. Kite will pay HiFiBiO $10 million upfront, plus unspecified milestones. In addition, Kite will have an exclusive option to license HiFiBiO's platform to screen T cell repertoires and to identify useful TCRs. HiFiBiO has facilities in Cambridge, Mass., Paris and Hangzhou.
Cellular Biomedicine (NASDAQ:CBMG) has been granted a Patent License for a next-gen neoantigen-reactive tumor infiltrating lymphocyte (TIL) technology from the National Cancer Institute of the US. The License gives CBMG non-exclusive, sub-licensable global rights to develop, manufacture and commercialize TIL technology. Financial details were not disclosed, nor did CMBG explain why the technology is "next-gen." Headquartered in Silicon Valley, CBMG has operations in Shanghai and Beijing, where it develops immunotherapies for cancer and stem cell treatments for degenerative diseases.
Ping An Good Doctor (HK: 1833) will partner with China Resources Sanjiu, joining Good Doctor's internet platform with CR Sanjiu's portfolio of OTC and prescription TCM products. Good Doctor includes an internet hospital, an in-house medical team and millions of users. It will promote CR Sanjiu's products, as well as create user profiles to help manage chronic diseases over the internet, and applying its big data capability to create new models of "internet + Chinese medicine healthcare" in China.
PharmaBlock Sciences (SZE: 300725) of Nanjing, a CDMO, has acquired a GMP compliant manufacturing facility in China from Porton Pharma (SZE: 300363). The facility, a three-year-old, 1.5 million square foot plant located in Shangyu, Zhejiang Province, will provide preclinical-, clinical- and commercial-stage manufacturing of intermediates for PharmaBlock clients. It is PharmaBlock's second manufacturing plant. At the new site, PharmaBlock plans to build an additional API manufacturing plant, with construction beginning this year. The purchase price was not disclosed.
Trials and Approvals
CANbridge Pharma of Beijing has filed a New Drug Application in China for Nerlynx (neratinib) as an adjuvant treatment in patients with early-stage HER2-positive breast cancer, following adjuvant Herceptin therapy. China's National Medical Products Administration (NMPA) has accepted the filing. CANbridge in-licensed Greater China rights to Nerlynx from Puma Biotech (NYSE:PBYI) in January 2018. In the US, Nerlynx was approved for the same indication in July 2017. CANbridge also intends to test Nerlynx in patients with HER2-positive gastric cancer. If approved, Nerlynx would be the third imported drug to be approved in China without a clinical trial.
Innovent Biologics of Suzhou reported that its IND application for IBI-188, a fully human anti-CD47 mAb drug candidate, has been approved to start US clinical trials in patients with advanced malignancies and lymphomas. Last month, China approved clinical trials for the same candidate. The candidate is Innovent's second molecule approved for US trials. The other, also an immunotherapy, is an anti-PD-1 antibody. Innovent is the first Chinese biopharma to be granted clinical trial approval for an anti-CD47 immunotherapy from the US FDA.
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