Welcome to this week’s FiercePharmaAsia report, which includes stories about the FDA approval of Takeda's Ariad-developed Alunbrig, WuXi NextCODE's $75 million Series B led by Temasek and Jack Ma-backed Yunfeng, Dr. Reddy's third FDA notice this year, and more.
The FDA approved Alunbrig, a key asset Takeda got from its $5.2 billion Aria buy, as a second-line treatment (after Pfizer and Merck KGaA’s Xalkori) for ALK+ non-small cell lung cancer. Encouraged by the trial data, the company believes in the drug’s ability to beat rivals Roche’s Alecensa and Novartis’ Zykadia, expecting peak annual sales to surpass $1 billion.
WuXi AppTec’s genomics subsidiary WuXi NextCODE has just secured a $75 million Series B, led by Singapore’s state-owned investment firm Temasek and Chinese internet tycoon Jack Ma-backed Yunfeng Capital. The money will be used to advance the company’s precision medicine capabilities, with national projects in China and Singapore, and one with AbbVie in Ireland.
Harvard Drug Group just recalled about 9,200 cartons of antifungal drug fluconazole manufactured by Dr. Reddy's at its Bachupally plant, because of dissolution issues. The recall comes as the facility was also cited in an FDA Form 483 with 11 observations, making it the third plant of India’s second-largest drugmaker to be reprimanded by the agency this year.
Looking to bolster its U.K. biotech reach, Tokyo-based Sosei has injected £35 million ($45.2 million) into MiNA, with an option to acquire the private RNA company in full with £140 million if work on its early-stage lead candidate, MTL-CEBPA, goes well. The small activating RNA candidate is currently in phase 1/2a for advanced liver cancer.
The Abu Dhabi Investment Authority and Singapore’s GIC, two government-owned wealth funds, have bought a minority stake in PPD, valuing the CRO giant at more than $9 billion. PPD expects to raise about $550 million, and the two new investors, together with existing owners Hellman & Friedman and the Carlyle Group, will contribute.
Takeda is teaming up with Harrington Discovery Institute to support research into treatments for rare diseases. Like its other initiatives, Harrington will provide funding and support to researchers from across the U.S. who have promising and novel early-stage drug development ideas. These researchers will also have access to Takeda’s internal R&D experts.
The FDA sent a warning letter to India’s Sal Pharma, saying that its Hyderabad API facility forged certificates of analysis. The agency found that the plant used products of unapproved API producers and claimed to its U.S. customers that they had been manufactured by Sal. Those included APIs for gastrointestinal and antifungal drugs.