Deals and Financings

HiFiBiO Therapeutics, a Boston, France and Hangzhou company that develops therapeutic immune modulators, closed a $67 Million Series C financing round led by new investor IDG Capital (see story). The company discovers novel drug candidates for cancer and autoimmune disorders using its proprietary single-B-cell screening and analysis platform. In May 2018, HiFiBiO completed a $38 million B round, which like the present financing, included predominantly China investors.

Beijing Huimei Healthcare closed a $30 million series C round funding led by Qiming Venture Partners to continue developing its AI-based Clinical Decision Support System (CDSS) (see story). CDSS offers support for medical diagnosis, combining natural language processing (NLP), deep learning and other AI-based technologies for diagnoses and clinical data management. Founded in 2015, Huimei is partnered with the US-based Mayo Clinic as a vehicle to bring medical best practices to China. Hillhouse and Mayo provided initial funding for the joint venture company.

CC-Pharming of Beijing acquired an exclusive, royalty-bearing license for China rights to a biosimilar version of Roche's Rituxan (rituximab) developed by iBio of Texas (see story). One year ago, it paid $4.7 million to form a joint commercial relationship with iBio giving CC-Pharming the right to use iBio's plant-based technology to develop and manufacture antibodies. At the time, the rituximab biosimilar was expected to be the first antibody developed by the partnership. CC-Pharming intends to use Bio’s FastPharming System for multiple products.

Zuga Medical, a Cleveland, Ohio medical device company, raised funds for its dental device products that allow dentists to install dental implants at the same cost as a bridge (see story). The company offers implants by combining computer-aided design (CAD), computer-aided manufacturing (CAM) and 3D printing to make customized dental components in the dentist’s office The size of the funding was not disclosed, though Zuga was recently expecting to raise up to $15 million. The company's primary market is the US, but it will also market its products in China.

Company News

Innovent Bio (HK: 01801) of Suzhou announced financial results for its first six months results as a commercial entity: the company launched Tyvyt®, its PD-1 checkpoint inhibitor on March 9 (see story). During the nearly four months of active sales, Tyvyt produced revenues of $46 million, nearly all of Innovent's revenues. Tyvyt is approved as a third-line treatment for classical Hodgkin's lymphoma, though Innovent is conducting 20 trials of Tyvyt, its first commercial product, eight of them pivotal. Innovent priced Tyvyt at $1,097 per vial, a 60% discount to Merck's (NYSE: MRK) PD-1, Keytruda.

Trials and Approvals

Ascletis Pharma (HK: 672) of Hangzhou announced approval of a China IND for a novel NASH drug candidate (see story). Earlier this year, Ascletis acquired exclusive rights to ASC40 (TVB-2640) in Greater China by leading an $25 million Series E financing in Sagimet Biosciences (then known as 3-V Biosciences) of San Francisco. In April, Sagimet began a global Phase II trial of the oral inhibitor of fatty acid synthase (FASN) in NASH patients. Ascletis' Ganovo®, the first China-developed direct-acting anti-viral agent for hepatitis C, was approved last year.

Harbour BioMed, a Boston, Rotterdam and Shanghai biopharma, formed a collaboration with PPD, a global clinical CRO. to develop HBM's novel portfolio of oncology and immunology assets (see story). The two companies recently completed a submission in Australia for an oncology immunotherapy that targets solid tumors, part of the requirements for starting Phase I trials. Founded in 2016, HBM includes a Dutch drug antibody discovery unit. Its portfolio includes five in-licensed candidates, a set of internally discovery molecules, and co-discovery/development collaborations with academic and biopharma entities.

Beijing's BeiGene (NSDQ: BGNE; HKEX: 06160) announced its US NDA for the company's BTk inhibitor was accepted by the FDA, its first NDA accepted in the US (see story). The company presented data on zanubrutinib from a China Phase II trial that enrolled 123 MCL patients, along with safety data from 641 patients in five clinical trials for other indications. BeiGene wants to expand the ex-China use of data from China trials to contain clinical costs. The FDA has granted Breakthrough Status for zanubrutinib and will review the candidate under Priority rules.

Government and Regulatory

China has passed a broad Amendment to its Drug Administrative Law, codifying the far-reaching changes to the country's drug approval/administration rules made over the last four years while also significantly increasing punishments for infractions (see story). The new regulations affect almost every part of the biopharma industry. For example, the very successful Marketing Administration Holder rules, which allow a company to outsource manufacturing of its products, will be expanded to all of China from the test provinces. In addition, new regulations to protect China's population from counterfeit or substandard vaccines will carry financial punishments of 10 to 50 times their value, much higher than previous punitive fines.

Disclosure: none.