Spotlight On... China continues crackdown on unsafe drugs, false data; TaiGen pneumonia drug caps PhIII trial; PharmaEngine cancer drug shows promise; and more...

China's Food and Drug Administration is continuing to crackdown on fraud and data manipulation in the drug manufacturing and development sector and announced this week it had turned down applications for 13 drugs by various companies and covered compounds used to treat heart problems, schizophrenia, pain, infections and other diseases. The drugs were not approved for a variety of reasons. The CFDA said in some instances the actual drugs were "unreal," test results were fabricated, test records were not kept, test results were manipulated or selectively used, data was deleted, clinical trials were improperly performed, and biological samples were mishandled. This is just the latest crackdown on the industry as the government moves to beef up confidence and force the sector to improve its manufacturing standards. The companies whose drugs were not approved include: Changzhou Pharmaceutical; Pharmaceutical Industry of Suzhou; West An Enco Pharmaceutical; Chongqing Huaxi Pharmaceutical; Shenzhen South Pharmaceutical; Hefei Vantage Long Connaught Pharmaceutical; Wuxi Fu Chi Pharmaceutical; Guangdong Aimin Pharmaceutical; Fuan Pharmaceutical Group; Qingyu Tang Pharmaceutical; Jiangsu Shenlong Pharmaceutical; Anhui Star Pharmaceutical; Shaanxi Ark Pharmaceutical and Guangdong Biti Pharmaceutical. Here's the release (PDF) (in Chinese) and a story from Reuters.

> Taiwan's TaiGen said its Taigexyn pneumonia drug has successfully met the primary endpoint in a Phase III clinical trial. Release

> Beijing-based BeiGene reported its Phase I candidate, BGB-3111, showed single-agent activity in B cell malignancy subtypes and was well tolerated in a presentation to the American Society of Hematology this week. The trial for BGB-3111 as monotherapy is being conducted in Australia and New Zealand with a dose expansion planned in 2016 and further clinical studies in combination with other agents. Release (PDF)

> HK-based Hutchison China MediTech, or Chi-Med, said its subsidiary Hutchison MediPharma has started a Phase III registration study of HMPL‑013 in China on third-line NSCLC patients. The first patient was dosed Dec. 8 with the candidate, known as fruquintinib. The trial plans to enroll approximately 520 patients across an estimated 45 clinical sites in China. Top-line results are expected in 2017. Release

> The National Research Institutes in Taiwan said clinical trials at eight hospitals showed a new pancreatic cancer drug developed by PharmaEngine called Onivyde could extend lives by six months and raise survival rates by 50%. Report

> China-based Frontline BioVentures said it has led an unspecified series A round of funding for Sino Health, a unit of China National Pharmaceutical Group, or Sinopharm. The funding is part of an effort to bring in more products for Sino Health from companies connected with Frontline which includes Suzhou-based Innovent Biologics and Shanghai-based Hua Medicine. Release

> China's Aoxing Pharma said it has opened a narcotic and psychotropic drug research center funded by China's Reform and Development Commission in Hebei province. Release

> China's Aoxing Pharma said its chief financial officer Wilfred Chow has resigned, senior vice president for finance Guoan Zhang will take over the post. Release

> Taiwan's OBI Pharma denied rumors it had wrongly granted shares to the president of a research academy who then was said to have transferred the shares to the company's president. Report

> The extension of the drug patent waiver by Bangladesh means generic drug sales are expected to triple by $3.8 billion annually by 2024. Report

> India pharma giant Cipla has reshuffled some of its management team for the third time in three years. Report

> China-based Akeso Biopharma has out-licensed global rights for an immuno-oncology antibody to Merck ($MRK) for an unspecified upfront payment and a potential $200 million in milestones for development and commercialization. Report

> Australia- and U.S.-listed Benitec Biopharma said initial in vitro data demonstrated efficacy for its hepatitis B candidate, BB-HB-331, in data presented at the HEP DART 2015 conference this month, setting the stage for consideration on in vivo testing. Release

> Chinese Nobel laureate Tu Youyou has called for a global effort to end malaria to keep the disease from gaining resistance to drug treatments. Report

> Indian biotech company Biocon is showing the way for other biotech companies in India where domestic companies account for about 2% of the global industry. Report

> India's Alkem Laboratories, the country's fifth-largest pharma by domestic sales, said it will try to raise at least $234 million in an IPO this week. Report

> Japan's Takeda Pharmaceutical said data from a Phase III study presented at a recent meeting of the American Society of Hematology showed treatment of multiple myeloma with its NINLARO (ixazomib) was effective in extending progression free survival. Release

> Australia's CSL Behring said "promising" data emerged from a recent Phase III trial of its hemophilia B treatment recombinant factor IX albumin fusion protein. Release

> Astellas Pharma Europe said it has presented data from a trial of its leukemia treatment Gilteritinib (ASP2215) and said it showed "inhibitory activity." Release

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