Fierce Pharma Asia—J&J, Legend's CAR-T win; Sanofi's India job cuts; BeiGene, Novartis' PD-1 delay

Johnson & Johnson and Legend said a phase 3 trial of their CAR-T therapy Carvykti in an earlier multiple myeloma setting was successful. Sanofi is cutting hundreds of jobs at two manufacturing facilities in India. The FDA has yet to perform long-delayed preapproval inspections in China as part of its review of Novartis and BeiGene's PD-1 inhibitor tislelizumab. And more.

1. J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma

Johnson & Johnson and Legend Biotech said the closely watched phase 3 CARTITUDE-4 trial of Carvykti has hit its goal. The BCMA-targeted CAR-T topped standard of care at staving off tumor progression or death in a second-line multiple myeloma setting. The trial win tees up more competition with Bristol Myers Squibb’s Abecma, which cut disease progression or death by 51% in the third line.

2. Sanofi offers retirement scheme to hundreds of staffers at 2 Indian vaccine plants

Sanofi is looking to eliminate about 800 jobs at two vaccine manufacturing plants in India through a voluntary retirement program. The two sites near Hyderabad make vaccines against hepatitis B, diphtheria and tetanus and also have packaging facilities for insulin. A Sanofi spokesperson said there’s no plan to sell any asset right now, but people familiar with the matter told Reuters that a sale could come later.

3. Novartis' Zolgensma, Leqvio lag among new launches as Entresto and Pluvicto steam ahead

Although China has relaxed its zero-COVID measures, Novartis still can't provide an update on the timing of preapproval inspections in China for a delayed review of BeiGene-partnered PD-1 inhibitor tislelizumab. Speaking to reporters Wednesday, CEO Vas Narasimhan said Novartis still expects COVID-related impacts on its China business in the first half of 2023. He confirmed the company’s goal to double China sales between 2020 and 2025.

4. IQVIA partners with Alibaba Cloud to expand services in China

Health information technology firm IQVIA has inked a deal with Alibaba Cloud in China. IQVIA is offering a suite of products for commercial customer engagement to be hosted locally in China in compliance with Chinese data residency regulations.

5. China approves 2 home-grown COVID oral antivirals from Simcere, Junshi (Quartz)

China has quickly approved two domestically developed COVID antivirals amid a shortage of COVID drugs. Simcere’s SIM0417 and Junshi Biosciences’ VV116 have been conditionally approved to treat mild to moderate COVID. SIM0417, a 3CL inhibitor, shares the same mechanism of action as Pfizer’s Paxlovid. VV116 is similar to Gilead Sciences’ remdesivir as both target the viral RdRp protein.

6. Sino Biopharm’s ill-fated F-star buyout nears deal with U.S. government (SEC filing)

Sino Biopharm might be able to buy F-star Therapeutics after all. The Chinese company, through its InVox subsidiary, inked a deal in June 2022 to buy the bispecific antibody specialist. But the national-security-focused Committee on Foreign Investment in the U.S. put the acquisition on hold late 2022. Now, in a securities filing, the two companies said they are “in the late stages of negotiating definitive terms” of an agreement with the U.S. authorities.