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All content provided by: ChinaBio® Today Published on August 21, 2015

China to Set Time Limit on Drug Approval Process

Government and Regulatory

By 2018, the CFDA must establish a specific limit for drug approval timelines, decreed China's State Council (see story). Within that specified period of time, the CFDA must either approve or reject a drug. The ruling was one of several broad reform initiatives for drug and medical device approval procedures, released by the State Council earlier this week. The major emphasis is on safety and efficacy, especially for the generic products that constitute the majority of the country's drug supply. Now, it's up to the CFDA to establish specific policies that achieve the goals. 

The CFDA promised to ease the regulations governing simultaneous China-global clinical trials of novel drugs and allow more data from global trials in its consideration of innovative products (see story). In addition, the CFDA pledged to wipe out its backlog of more than 20,000 drug approval requests by the end of 2016, according to a Bloomberg article. Foreign drugmakers can ask the agency to speed up the China review process if the drug addresses unmet needs. However, the price for the drug cannot exceed the price charged in the drug's home market or in countries similar to China. 

Deals and Financings

Burning Rock Biotech, a Guangzhou oncology diagnostics company, completed a $23 million Series A+ round of funding (see story). The company is developing diagnostic tests for solid tumor cancers that indicate the best treatment option for each patient. Investors in the round include Jifeng Capital (Lyfe), Sequoia Capital and Legend Star. Founded in March 2014, Burning Rock raised $9.7 million in the Series A round last year from Northern Light Venture Capital and Legend Star, an incubator program of Legend Holdings. 

Singapore's Asian American Medical Group (AAMG) paid $14 million for a 60% interest in a Zhuhai diagnostic and wellness medical center, which will be built in Zhuhai to serve the Hong Kong, Macau and Shenzhen markets (see story). AAMG and its real estate partner will build a $57 million, 12-storey facility to offer out-patient health screening, medical procedures, multidisciplinary consultations and aesthetic services. Construction is expected to be completed by 2017. 

Anpac Bio-Medical Science of Shanghai said Shanghai Zhangjiang Science &Technology Investment Corporation made a Series A investment in Anpac equivalent to "several million dollars" (see story). Using its Cancer Differentiation Analysis (CDA) technology, Anpac has developed tests with high rates of sensitivity and specificity for early cancer screening. Anpac said it would use the funds to add a US headquarters and clinical trials to its China operations. 

Janssen Pharma, a Johnson & Johnson (NYSE: JNJ) subsidiary, has ended its anti-inflammation collaboration with Hutchison MediPharma, the drug R&D arm of Hutchison China MediTech (AIM: HCM) (see story). HMP will continue to develop the collaboration's lead molecule, HMP-507, a small molecule candidate that targets a novel inflammation/immunology kinase. To date, HMP has received $13 million in upfront, milestone and development payments for the program. No reason was given for Janssen's decision. 

BeiGene, a Beijing biopharma developing novel oncology drugs, plans to build a cGMP manufacturing facility in Suzhou's BioBAY (see story). The 97,000 square feet facility, which is expected to be completed in 2017, will supply products for clinical trials and commercial sale. BeiGene currently lists eleven molecules in development, three of them in proof-of-concept trials. Its portfolio is focused on targeted and immuno-oncology therapeutics. 

Disclosure: none.

source: ChinaBio® Today. Copyright © 2015 ChinaBio® LLC. Redistributed with permisssion. All rights reserved.

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ChinaBio® Today is the most widely read source for news and insights on the rapidly evolving life science industry in China. From our offices in Shanghai and California, we provide daily news, commentary and analysis on China life science companies and industry events, as well as global issues affecting the China life science market.
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