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All content provided by: ChinaBio® Today Published on July 26, 2014

CFDA to Outsource Drug Reviews

Government and Regulation

The Center for Drug Evaluation at the CFDA will begin outsourcing reviews for generic drug approvals to speed up the process, said Yin Li, Deputy Director of the CFDA at a recent conference (see story). The outsourcing will be either to China’s provincial drug agencies or independent third parties. The agency will also consider raising application fees, partly to discourage the many filings for generic drugs that already have multiple suppliers. In addition, the CDFA is being advised to allow new drugs to begin clinical trials if the agency does not approve the IND filing within 90 days.

Deals and Financings

Skystar Bio-Pharma (NSDQ: SKBI), a China veterinary medicine company headquartered in Xi’an, raised $5 million through a private placement (see story). The company said it would use the funds for acquisitions, in-licensing of vaccine and aquaculture products, and R&D, along with general corporate purposes. Before the transaction, Skystar had just under $7 million in cash.

In a complicated deal, Welichem Biotech (TSX-V: WBI) of Canada ended its attempt to buy back China rights to a topical psoriasis treatment from Shenzhen Celestial Pharma and Beijing Wenfeng Tianji Pharma (see story). The company explained that China authorities have not given their approval to the deal, and the Board decided approval was not likely. Welichem originally sold China rights to WBI-1001 in September 2004 in exchange for a $1.5 million investment by Celestial in Welichem.

Trials and Approvals

CASI Pharma (NSDQ: CASI), a US company formerly known as EntreMed, received CFDA permission to start a China Phase II trial of its proprietary drug for triple-negative breast cancer (see story). The trial will be combined with a US Phase II trial, already in progress. CASI says that ENMD-2076, an orally-active, Aurora A/angiogenic kinase inhibitor, has a unique kinase selectivity profile and multiple mechanisms of action. CASI filed for approval of the trial in China eighteen months ago.

Berry Genomics of Beijing is seeking CFDA approval for its noninvasive prenatal test, which runs on a customized Illumina (NSDQ: ILMN) NextSeq 500 sequencer (see story). The two companies co-developed the sequencer. Berry Genomics’ Bambni™ assay, which has completed more than 200,000 samples, includes a unique PCR-free library prep technology and proprietary RUPA™ analysis software. Berry said it is in late-stage review at the CFDA.

Company News

Next month, Merck KGaA (Xetra: MRK) will break ground on its new $108 million Shanghai manufacturing plant, which will be the company’s second largest manufacturing facility anywhere in the world (see story). Construction will be complete in 2016 and commercial production will begin the following year. Merck positioned the investment as symbolic of its commitment to the China market. The plant was originally announced in November 2013.

BGI Tech Solutions, a division of Shenzhen’s sequencing giant BGI, launched a human whole exome sequencing service at a cost of $599 per sample (see story). The service combines the platform developed by Complete Genomics, which BGI acquired last year, and BGI’s own expertise in deep genome and exome sequencing. The introductory price includes bioinformatics analysis and SNP validation.

China Cord Blood (NYSE: CO) of Hong Kong will cooperate with Singapore’s Cordlife Group (SGX: CLGL) to find suitable donors in each other’s umbilical cord blood stem cell banks (see story). If a matching donor cannot be found in a company’s own facilities, the partner may be asked to search its registry. China Cord Blood owns licenses for Beijing, Guangdong Province and Zhejiang Province, while Cordlife has facilities in Singapore, Hong Kong, India, Indonesia, the Philippines and Malaysia. In 2012, Cordlife invested $20 million in China Cord Blood.

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