FiercePharmaAsia—China audits for Big Pharma; Takeda's phase 3 trial failure

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New York biotech Athenex has ceased production at a China site after March explosions at a plant managed by another drugmaker. (Google)

An accounting slip-up by China’s Kangmei Pharmaceuticals has triggered a headache for the industry. Plus, Takeda entered a Canadian R&D collaboration and disclosed a new phase 3 trial failure. After plant explosions in China earlier this year, Athenex has suspended production at its own API facility. And more.

1. Eli Lilly, BMS among 77 drugmakers targeted in Chinese financial probe 

After Kangmei Pharmaceuticals overstated its cash holdings, China’s government is randomly auditing 77 pharma companies. Among them are local arms of Eli Lilly, Sanofi and Bristol-Myers Squibb. But it’s not just multinationals getting a close look; China is also looking at financials for its domestic drugmakers. 

2. Amgen, Takeda join intracellular delivery R&D collaboration 

Takeda joined a Canadian R&D collaboration called Feldan Shuttle that’s working on a novel drug delivery technology intended to help transport proteins directly into cells. So far, Sanofi, GlaxoSmithKline, Janssen and Amgen have gotten involved. The Quebec government and CQDM, a public-private research consortium, are also backing the project.

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3. Takeda swings and misses with Ninlaro in AL amyloidosis, calls off phase 3 trial 

Meanwhile, Takeda this week also posted a trial miss for Ninlaro in systemic light-chain amyloidosis. The drug is a growth engine for the company but didn’t meet an endpoint in the study. As a result, Takeda shut the study down. Ninlaro, approved in combo with Revlimid and dexamethasone to treat multiple myeloma patients who've received at least one prior therapy, is still in testing for newly diagnosed multiple myeloma and as a maintenance therapy in certain multiple myeloma patients.  

4. Athenex voluntarily suspends production at its Chongqing, China, API plant 

After an explosion at Jiangsu Tianjiayi Chemical Company in Yancheng, China, killed 78 people in March, New York biotech Athenex suspended production at its own facility. The March explosion triggered industrywide plant inspections in the country. Athenex said it expects to have its issue resolved by the end of the third quarter.

5. Indian injectables maker KriGen to build $7M plant in North Carolina 

India-based injectables maker KriGen Pharmaceuticals plans to build a $7 million, 55,000-square-foot plant in Lillington, North Carolina. In the process, the company will create 100 jobs in the area. At the site, the company will produce medical IV bags and injectables. KriGen is getting a $200,000 grant from the One North Carolina Fund for the work.

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