Fierce Pharma Asia—Sanofi's flu shot setback; DualityBio's IPO plan; UCB's China asset sale

Sanofi has suspended distribution of its two flu vaccines in China out of concern of waning potency. BioNTech's antibody-drug conjugate partner, DualityBio, has filed for a Hong Kong IPO. UCB will offload some Chinese assets for $680 million. And more.

1. Sanofi halts flu vaccine distribution in China over fear of declining potency

Sanofi has temporarily stopped selling its two flu vaccines, Vaxigrip and VaxigripTetra, in China after a routine quality follow-up test flagged a decline in the vaccines’ potency in doses that were not yet distributed. The company attributed the problem to “unexpected circumstances” at the company’s production line in Shenzhen, China, which supplies doses only for the Chinese market.

2. Duality plans Hong Kong IPO to fund trials of BioNTech-partnered ADCs and beyond

China’s Duality Biotherapeutics has filed for a Hong Kong IPO. The antibody-drug conjugate specialist set up shop in 2019 and has attracted deals with BioNTech, BeiGene and Adcendo that could be worth more than $4 billion combined. Duality named BioNTech-partnered ADCs targeting HER2 and B7-H3 as its “core products,” with the HER2 program nearing a potential application for accelerated approval in 2025.

3. UCB sells off production plant and a clutch of older meds in China for $680M

Another foreign company is trimming its business in China. UCB is selling off its mature neurology and allergy brands in mainland China, plus a manufacturing site in the Chinese city of Zhuhai, to investment shops CBC Group and Mubadala for $680 million. The Belgian company will instead explore the launch of novel medicines in immunology, neurology and rare diseases in China, UCB CEO Jean-Christophe Tellier said.

4. FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

The FDA will hold an advisory committee meeting to discuss whether approvals for PD-1 inhibitors in advanced gastric and gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma should be restricted based on tumors’ PD-L1 expression. BeiGene’s two open applications for Tevimbra, plus existing approvals for Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, will be examined closely.

5. As sales climb, Jazz's Epidiolex falls short in Japanese study in treatment-resistant epilepsies

A phase 3 Japanese study of Jazz Pharma’s cannabinoid drug Epidiolex has failed on the primary endpoint measuring seizure frequency in certain patients with treatment-resistant epilepsies. Still, the company pointed to numeric improvements across primary and secondary endpoints, as well as the drug’s overall global data, saying it plans to speak with Japanese authorities about a potential filing.

6. Ipsen sues CSPC Pharma to block rival to cancer drug Onivyde (Bloomberg Law)

Ipsen has filed a patent infringement lawsuit against China’s CSPC Pharma. The lawsuit centers on Ipsen’s Onivyde, a liposome formulation of the chemotherapy irinotecan, and CSPC’s irinotecan liposome candidate, which was filed with the FDA in late 2023 for previously treated pancreatic cancer. Ipsen alleges that CSPC steps on its new patent, which was issued Aug. 13, according to the complaint (PDF).

Other News of Note:

7. Bora's expansion tear continues as CDMO takes up stake in Tanvex, gains manufacturing capabilities

8. With new focus, Kyowa Kirin pulls decades-old breast cancer drug Fareston from US market

9. Bharat Biotech to launch oral cholera vaccine developed in partnership with Hilleman Labs (release)

10. Tech company Fujitsu partners with Paradigm Health to boost clinical trials in Japan

11. YolTech sells China rights to cholesterol gene editing therapy to Salubris for $29M

12. API maker Global Calcium stung with Form 483 filing after FDA inspection of Indian plant