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All content provided by: ChinaBio® Today Published on August 29, 2015

Hepalink Pharma Buys US-based CMO Cytovance

Deals and Financings

Shenzhen Hepalink Pharma (SHZ: 002399) will acquire Cytovance® Biologics, a US biologics contract development manufacturing company, for $205.7 million plus unspecified contingency payments (see story). Hepalink plans to retain Cytovance's management, its 178 employees and its Oklahoma City facilities. With its capital, Hepalink expects to accelerate Cytovance's expansion plans. This includes adding 5,000L and 10,000L mammalian reactors and 1,000L and 5,000L microbial fermentors. 

Shanghai Pharma (SHA: 600196), China's largest drug distributor, will launch a China healthcare venture capital investment fund that will ultimately raise $470 million (see story). The first tranche will be $157 million and Shanghai Pharma will contribute 25% of that, or just under $40 million. The VC fund will back healthcare start-ups in all life science fields. The news came from a securities filing. 

DynoSense, a San Jose medical device company, closed a $9.4 million Series A funding round from a group of China-US investors that included WI Harper Group; JKOM Cloud Health Technology; Plug and Play Tech Center; Jinmao Capital; and Wilson, Sonsini, Goodrich and Rosati (see story). With the new capital, DynoSense will seek US regulatory approval and commercialization of Dyno, a remote, multi-function device that captures 33 health metrics, uploads the data to the cloud, and then transfers it to medical professionals. 

Jiangxi Boya Bio-Pharmaceutical (SHZ: 300294), a blood products pharma, agreed to make two acquisitions: it purchased an 84% stake in Nanjing Xinbai Pharmaceutical in exchange for stock, and it also acquired a 28% interest in Guizhou Tianan Pharma for cash (see story). Neither amount was disclosed. To pay for the transaction, Boya said it would raise as much as $78 million through a private placement. The raised capital will also help pay for building Boya's new R&D center and development of new coagulation factor products. 

Harbin Gloria Pharma (SHZ: 002437) will acquire a 70% interest in Sheyang Zhenyang Hospital (Sheyang branch of Second Affiliated Hospital of Nanjing Medical University) for at least $27.5 million (see story). Hospital management is a new field for Gloria, which is known as a maker of injectible drugs. Gloria is treating the acquisition as a test case: if the purchae proves profitable, Gloria will seek to build a portfolio of China hospitals. 

Cellular Research, a Silicon Valley genetics company supported by China's Decheng Capital, has been acquired by BD Life Sciences (see story). BD Life Sciences is a division of medical technology company BD (NYSE: BDX) (Becton, Dickinson and Company). Cellular Research has developed a next-generation single cell preparation technology that, according to the company, "offers absolute quantification of gene expression with orders of magnitude improvement in throughput and cost." 

Shanghai Kehua Bio-Engineering (SHZ: 2022), an IVD company, signed an MOU to acquire Technogenetics, an Italian maker of diagnostic tests, from its parent, Bouty Healthcare (see story). Kehua will also buy all the diagnostic assets of Altergon Italia. Technogenetics offers clinical diagnostic tests for autoimmune and infectious diseases tests, using the IDS-iSYS chemiluminescence machine. Kehua, which has until October 15 to complete the deal, will first perform due diligence and then negotiate a final agreement.

ECM Medical, US-China medical device company, acquired China rights to a novel spinal fusion device developed by Vertebral Technologies of Minnesota (see story). The Interfuse™ System of spinal lumbar implants, using a proprietary modular technology, is designed to provide a large, biomechanically stable footprint even though the procedure is minimally invasive. ECM, which will be in charge of China registration for the device, will distribute it in China, Hong Kong and Macao. Financial details were not disclosed.

Lee's Pharm (HK: 0950) signed a strategic license to register and market in China two single dose infusion products from BioQuiddity of San Francisco: ropivacaine, a local anesthetic, and propofol, an anesthetic-sedative (see story). BioQuiddity makes one-dose, ready-to-use infusion products. Eddingpharm will have rights to the drugs in mainland China, Taiwan, Hong Kong, and Macau. Financial details were not disclosed. 

Eddingpharm in-licensed greater China rights to a second drug from Canada's Cardiome (NSDQ: CRME; TSX: COM): Aggrastat® (tirofiban hydrochloride), an anti-platelet therapy (see story). In December 2014, Eddingpharm in-licensed China rights to Brinavess® (vernaklant), a Cardiome treatment for atrial fibrillation. Eddingpharm, which must conduct clinical trials for both drugs, agreed to make milestone payments and also committed to minimum annual commercial sales. Both drugs will be marketed to cardiovascular specialists. 

Government and Regulatory

The CFDA may soon have a plan for expedited IND approvals that would render a decision within 60 days (see story). That would be a big change. Currently, companies must wait one to two years (or longer) before the agency rules on whether they can begin China clinical trials of a new drug. Several Asian countries -- Taiwan, Singapore and South Korea -- already have expedited approvals. China is drawing up plans for a pilot program for use with oncology drugs. Presumably, it will be put to wider use if the program works. 

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