Spotlight On... 3SBio gets China FDA IND nod for PEG-irinotecan candidate; China FDA plans safety patrols; India's compulsory license stance eyed; and more...

Shenyang-based 3SBio won an investigational new drug nod from China FDA to start trials of in-licensed chemotherapy candidate PEG-irinotecan. The candidate was originally developed by Beijing-based JenKem Technology and China rights came to 3SBio in 2014. The financial terms were not available. Irinotecan is a first generation Topo-I inhibitor and was approved in the U.S. in 1994, though issues with toxicity and a short half-life came to the fore. The PEGylated version however was designed to overcome those issues. "3SBio intends to develop PEG-irinotecan as a National Class I drug for relapsed or refractory cancers, such as colorectal cancer, metastatic breast cancer, and platinum-resistant ovarian cancer," the company said in a release. "In China, the incidence rates for colorectal cancer, breast cancer and ovarian cancer are 33.1 per 100,000, 27.3 per 100,000 and 4.9 per 100,000 annually." 3SBio returned to the public markets in July last year via the Hong Kong Stock Exchange and has expanded its activities in deal making and biotech drug development. Release

> China FDA will step up safety inspections under special central government teams that will "patrol" manufacturing and other sites from March 1 to the end of April under a directive from the country's top leadership. Release (Chinese language)

> India drug makers and the U.S. trade representative are closely watching policy signals on compulsory license applications pending that include Bristol-Myers-Squibb's ($BMY) dasatinib (Sprycel), and Onbrez respiratory treatment from Novartis ($NVS) after no such approvals were granted in 2015. Report

> Shanghai-based biotech 3DMed and Suzhou's Alphamab will jointly develop injectable therapy PD-L1 immuno-oncology candidate KN035, with a filing for China clinical trials slated in the second quarter and U.S. trials at some point thereafter, according to a report. Financial terms were not disclosed. Report

> Shenzhen-based Mindray Medical International ($MR) has completed a merger announced in November with Solid Union, a subsidiary of Taipei-listed medical equipment distributor Excelsior Union. Release

> Researchers in Australia have found a strong link between stress levels and the spread of cancer that has implications for therapy regimens, Xinhua said, citing results published in the Nature Communications. Report

> Teva Pharmaceutical Industries ($TEVA) has completed the purchase of Mexico City-based drug manufacturer and distributor Representaciones e Investigaciones Médicas, bolstering its Latin American and European reach. Release

> Ten unnamed India-based drug firms face license suspensions to manufacture generic Liposomal Amphotericin B used to treat fungal infections, with a health ministry committee citing safety and efficacy concerns. Report

> An Australian civil society group, CONSUMERS, has filed a class action lawsuit against Nurofen makers Reckitt Benckiser over marketing and price issues. Report

> China will hike the statutory retirement age above 60 for men, 55 for white-collar women workers and 50 for blue collar workers under a 5-year phase-in plan starting in 2017, Xinhua reports, without specifying the endpoints in any of the categories. Report

> Life expectancy in China's heavily polluted capital Beijing rose slightly to 81.95 years in 2015, Xinhua said, with the three top fatal causes listed as cancer, cardio and cerebral vascular diseases. Report

> Beijing-based China Biologic Products ($CBPO), listed on the Nasdaq, priced a secondary offer of 3.87 million common shares at $110 each. Release

> Shenyang-based 3SBio has named Kevin Xiao Weihong chief operating officer, noting his previous post with Hangzhou-based joint venture of Zhejiang Hisun Pharmaceutical and Pfizer ($PFE) as chief for strategy and operations. Release

> The U.S. arm of Tokyo-based Astellas Pharma named Martin Golden as senior vice president and head of Marketing Strategy, a global role; Frank Hudson as senior vice president and head of Budget & Control, Medical & Development; and Walt Johnston, Mark Reisenauer and Kenton Stewart were promoted to senior vice presidents, with responsibility for commercial activities in the U.S. in the areas of urology and hospital, oncology, and hospital and health systems, respectively. Release

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