BeiGene and Novartis' PD-1 inhibitor was delayed at the FDA as the agency couldn't conduct inspections in China. Big Pharma's off-patent drugs once again lost major supply contracts in China's latest price-cutting scheme. A Pfizer partner on a PD-L1 inhibitor in China is reportedly exploring a sale. And more.
1. Novartis, BeiGene's PD-1 drug the latest to hit FDA wall as pandemic stalls another review
BeiGene and Novartis’ PD-1 inhibitor tislelizumab has fallen victim to COVID-related travel restrictions. The FDA has delayed a decision for the drug in esophageal squamous cell carcinoma, citing trouble conducting inspections in China. BeiGene has been supplying tislelizumab through its facility in Guangzhou and CDMO partner Boehringer Ingelheim.
2. AstraZeneca, Pfizer, Novartis and more lose out in China's latest round of drug price cuts
In China’s latest volume-based procurement, local companies producing generics came in with aggressive bids to win supply contracts with public hospitals. Eisai’s Lenvima, AstraZeneca’s Seloken/Toprol XL, Pfizer’s Sutent, Roche’s Tamiflu, Gilead’s Vemlidy, Novartis’ Zofran are among a long list of originators that have lost out to local generic players.
3. Pfizer partner CStone explores sale as US path blocked, Chinese competition heats up: Bloomberg
CStone Pharmaceuticals, Pfizer’s Chinese partner for freshly China-approved PD-L1 inhibitor Cejemly (sugemalimab), is exploring a sale, Bloomberg reports. Outside of the U.S., the drug has been licensed to EQRx. The deal rumor comes as PD-1/L1 competition in China intensifies, and as the regulatory path for China-developed cancer drugs just turned bumpier.
Thanks to a historic trial success in HER2-low breast cancer, Daiichi Sankyo and AstraZeneca’s Enhertu could challenge Gilead Sciences’ Trodelvy in triple-negative breast cancer and might eventually leap ahead of the latter in the treatment sequence, two experts told SVB Securities analysts. As for the much larger HR-positive field, Enhertu will become standard of care regardless of HER2 expression status, the experts said.
5. Sinopharm considering $1B buy for Shanghai-based DNA maker BBI Life Sciences: report
China’s state-run Sinopharm is considering a $1 billion deal to acquire BBI Life Sciences, a Shanghai-based company making research-supporting products. BBI provides raw materials and consumables for life science research, including reagents and molecularly building blocks for constructing synthetic DNA.
6. Dr. Reddy's reveals FDA write-up at Indian formulation plant
A Dr. Reddy’s Laboratories formulations manufacturing facility in Srikakulam, Andhra Pradesh, India, was slapped with an FDA Form 483 after a preapproval inspection. The company didn’t specify the exact observations but said it will address those concerns “within the stipulated timeline.”
7. Dr. Reddy's launches extended-release rival to $200M Pfizer drug
Meanwhile, Dr. Reddy’s has launched a generic copying Pfizer’s extended-release overactive bladder treatment Toviaz. The originator drug has been pulling in over $200 million in annual sales. Because of Pfizer’s marketing exclusivity, the Dr. Reddy’s generic isn’t labeled with pediatric use.
8. Top biotech investors Qiming, Sequoia China raise new funds (release, Bloomberg)
Despite an uncertain investment market, prominent venture capital firms and regular biotech investors Qiming Venture Partners and Sequoia China have raised large funds. Qiming, a backer of Zai Lab, just raised $3.2 billion for funds that focus on early technology, consumer and healthcare projects. Sequoia China, which has invested in WuXi AppTec, reportedly raised $9 billion, also for investments in technology and healthcare.
Other News of Note
9. Athenex unloads stake in Chinese API production business for $19M to bolster its financials
10. Jubilant HollisterStier to pump $76M into Montreal facility
11. Take 2: Hanmi relaunches liver drug after boosting bioavailability
12. CASI pockets $5M for autoimmune drug deal as China's Precision secures $21M funding