Novartis is tapping into Argo Biopharmaceutical's siRNA capabilities again in a deal worth up to $5.2 billion. The FDA approved a subcutaneous version of Eisai and Biogen's Leqembi. The Hong Kong Stock Exchange issued sanctions against Shanghai Henlius Biotech and its former CEO over a questionable reallocation of IPO proceeds. And more.
1. Novartis returns to Argo for multifaceted $5B cardiovascular collab
Novartis has returned to China siRNA biotech Argo Biopharmaceutical for more cardiovascular assets. In a deal potentially worth $5.2 billion, Novartis gained options to two discovery-stage molecules for severe hypertriglyceridemia and mixed dyslipidemia, plus a right of first negotiation to ANGPTL3—an RNAi therapeutic—following a combination trial in dyslipidemia. Argo gets $160 million upfront in the deal.
2. Eisai secures FDA green light for Leqembi autoinjector, teeing up at-home maintenance dosing
The FDA has approved a subcutaneous version of Eisai and Biogen’s Leqembi as maintenance treatment for Alzheimer’s disease. The drug, called Leqembi Iqlik, is given once a week via an autoinjector. Eisai hopes the more convenient formulation could save healthcare resources and increase uptake of the medicine. The company also initiated an FDA rolling submission for Leqembi Iqlik as a starting dose.
3. Hong Kong exchange disciplines Henlius over $117M asset management lapse (PDF)
The Hong Kong Stock Exchange is censuring Shanghai Henlius Biotech and sending its former CEO Scott Shi-Kau Liu to 26 hours of training on regulations and listing compliance rules. The issue dates back to the biotech’s IPO in 2019. The exchange found that Henlius and Liu breached its rules by redirecting $117 million, or 29% of the biotech’s IPO proceeds, to a questionable investment vehicle even though such use was not listed in Henlius’ prospectus. Liu greenlighted the deal, signed on the day of the IPO by Henlius’ then-Chief Financial Officer Zidong Zhang, Ph.D., without examining the agreement document or bringing the matter to the board for consideration. Henlius and Liu did not contest their respective breaches and agreed to their sanctions, according to the exchange.
The overall survival benefit observed for Amgen and Zai Lab’s anti-FGFR2b drug bemarituzumab in a phase 3 stomach cancer trial has “attenuated,” Zai said. The study, coded Fortitude-101, tested adding the drug to chemotherapy in first-line, HER2-negative gastric or gastroesophageal junction cancer with FGFR2b overexpression. Back in June, the pair said the study met its primary endpoint of overall survival at an interim analysis.
5. AstraZeneca, exiting production digs in India, surrenders local manufacturing license
AstraZeneca has handed in its manufacturing license in India as the British pharma plans to exit from its lone production facility in the country. In 2023, the company disclosed its intent to shutter its Bengaluru plant “in due course.” After failing to find a suitable contract manufacturer to take over the place, the company is still aiming to sell the facility.
6. India’s drug regulator eyes lighter oversight, more AI to boost efficiency (Reuters)
To increase efficiency, India’s drug regulator is working to reduce certain requirements and processing time. “We’re trying to increase our efficiency, cutting down on regulations so that we create more and more resources within our system,” the Central Drugs Standard Control Organisation's Rajeev Raghuvanshi told Reuters on the sidelines of an industry event.
Other News of Note:
7. Lilly links up with JD Health for DTC obesity, diabetes drug sales in China
8. Korean ADC developers debate strategies to counter China’s rapid rise (Korea Biomedical Review)
9. Roche’s Chugai adds new safety measure for Sarepta’s Elevidys in Japan (Regulatory tracker)
10. Fosun rises again, inking 3rd inflammatory disease deal in 3 weeks
11. Henlius, Organon win FDA nods for biosimilars to Amgen’s Prolia, Xgeva (Release)