A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind a recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. Singapore biotech Aslan Pharma is winding down. And more.
The Form 483 that led to the FDA’s rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab included 10 observations issued to Hengrui’s subsidiary, Suzhou Suncadia Biopharmaceuticals. In addition, the FDA has upgraded a prior eight-observation Form 483 into a warning letter for Hengrui’s small-molecule facility in Lianyungang, China.
2. Sanofi to more than double its workforce at Hyderabad site with $437M expansion: reports
Sanofi will invest 400 million euros through the end of the decade to expand its global capacity center in Hyderabad, India. Sanofi plans to grow the site’s workforce to 2,600 people—from 1,000 today—in two years, making it the largest of the company’s four global capacity hubs. The site will grow its digital capabilities, including utilizing artificial intelligence tools.
3. Aslan’s dream of challenging Dupixent dies as cash-strapped biotech winds down
Aslan Pharmaceuticals, one of the first Singapore-based biotechs to rise to the global stage, is shutting down. With $18.4 million in cash as of the end of March, the company has decided to file for liquidation and has let go all its staffers. The biotech’s stock price was once worth nearly $390 a piece at its peak in 2018 until its lead program, the pan-HER drug varlitinib, failed. Before the decision to close doors, Aslan received a delisting warning from Nasdaq as its stock price had been trading below the $1 bid price.
4. J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer
Legend Biotech reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser, according to StreetInsider. The stock price surged for Legend and its former parent and largest shareholder, GenScript. The report came a few weeks after two House lawmakers had requested an intelligence briefing on GenScript and its related operations, including Legend.
5. SK inks $572M deal for Full-Life prospect, advancing push to become Asia’s radiopharma leader
SK Biopharmaceuticals inked a $571.5 million biobucks deal to license an NTSR1-directed radionuclide-drug conjugate candidate, FL-091, from Full-Life Technologies. NTSR1 is overexpressed in colorectal, breast, pancreatic, and head and neck cancers. The Korean company outlined plans a year ago to expand in oncology and identified radiopharmaceuticals as one of the modalities driving the push.
Other News of Note:
6. Sotio taps Biocytogen to create bispecific ADCs in $326M deal
7. Aveo spins a silver lining in failed trial of kidney cancer drug Fotivda
8. BeiGene brings on Merck veteran as new CFO (release)