Tanvex BioPharma, Inc.

Sanofi's flu vaccine manufacturing hiccup in China, DualityBio's proposed Hong Kong IPO and UCB's $680 million sale of some Chinese assets made our news this week. 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 potencySanofi 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 beyondChina’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 $680MAnother 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 medsThe 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 epilepsiesA 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 capabilities8. With new focus, Kyowa Kirin pulls decades-old breast cancer drug Fareston from US market9. 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 Japan11. YolTech sells China rights to cholesterol gene editing therapy to Salubris for $29M12. API maker Global Calcium stung with Form 483 filing after FDA inspection of Indian plant

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Coalition for Epidemic Preparedness Innovations (CEPI) is partnering with and funding a research project for Afrigen Biologics to investigate if the use of synthetic DNA can speed up mRNA vaccine development. The synthetic DNA will be manufactured and supplied by the CDMO Syngoi. The research project will develop a vaccine for Rift Valley fever, according to a Tuesday press release. Bora Pharmaceuticals is gaining a 30.5% share in Tanvex Biopharma in a new partnership that will combine their manufacturing services. Bora will provide its 10 global manufacturing sites and Tanvex will provide its commercial facility in San Diego, CA. No financial details were given. Bharat Biotech is launching an oral cholera vaccine, dubbed Hillchol, to address cholera vaccine shortages. The company will manufacture this out of its facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses, the company said on Tuesday. John Kosolcharoen, CEO of two stem cell manufacturing companies, pleaded guilty on Monday for marketing products linked to patient hospitalizations. Since 2016, the two companies, called Liveyon LLC and Genetech Inc. have been making and shipping unapproved injectable stem cell products manufactured from human umbilical cord blood. Kosolcharoen lied to the FDA stating these were being sold for research purposes only, as per a DOJ press release on Tuesday. AstraZeneca’s manufacturing facility in Södertälje, Sweden, has achieved a 98% reduction in greenhouse gas emissions since 2015, the company said on Thursday. ScaleReady has awarded a $20 million grant to Stanford Medicine Laboratory for Cell and Gene Medicine to help the development of its CAR-T cell therapy manufacturing platform. The funding will be used to investigate the manufacturing tech in a Phase 1 clinical trial for Glypican 2 pediatric neuroblastoma and medulloblastoma, the company said on Tuesday. Trinity Capital is investing $35 million into drug delivery device manufacturer ApiJect Systems. The funding will be used to expand ApiJect’s manufacturing footprint with a new facility, according to a press release on Tuesday. Molecular Assemblies has received $4 million in funding from the Defense Advanced Research Projects Agency (DARPA) to further develop its DNA synthetic technology. The funding will be used for future tech transfers and to develop other software like gene synthesis, the company said on Wednesday. Injectable CDMO Simtra Biopharma Solutions has tapped Lonza’s VP of Biologics, Lidia Serina, as its new head of development services. Prior to working at Lonza, Serina held positions at GSK, Sanofi and CureVac. CDMO Huateng Pharma is expanding its services to include manufacturing pharmaceutical and veterinary APIs, chemicals and cosmetic ingredients, according to a press release on Wednesday. Lupin Pharmaceuticals is voluntarily recalling 4554 bottles of its cefixime oral suspension from the US due to an out-of-specification result. The class 2 recall started on Aug. 21, according to a FDA report published on Monday. Dr. Reddy’s Laboratories is also voluntarily recalling 103,298 bottles of 800 mg ibuprofen tablets after a specification study showed some levels of impurities. The bottles are being recalled from the US and Puerto Rico, and the process is ongoing. The FDA classified this as a class 2-level recall.

Bora Pharmaceuticals continued its global expansion push by buying a stake in Taiwanese drugmaker Tanvex Biopharma. Bora Pharmaceuticals extended its expansion tear by taking a 30.5% stake in fellow Taiwanese drugmaker Tanvex BioPharma, boosting the CDMO’s biomanufacturing capabilities.The deal, which is expected to be completed in the first quarter of 2025, will make Bora the largest shareholder in Tanvex. It also gives Bora access to Tanvex's commercial-scale production facility in San Diego, the CDMO said in an Aug. 27 press release.Tanvex boasts more than 100,000 square feet of biomanufacturing space and operates 1,000- liter bioreactors, which will complement Bora’s 500-liter bioreactors, Bora added. The companies "will combine their biomanufacturing facilities to create a global solution for biologics development and supply," according to Bora's release.Bobby Sheng, Bora Group’s chairman and CEO, will become chair of the merged organization.“This partnership will enable the combined entity to rapidly respond to evolving industry demands and policy developments, such as the BIOSECURE Act in the US, and capitalize on new opportunities in onshoring, friendshoring, and the growing CDMO demands driven by these policy changes,” Sheng said in the release. The investment in Tanvex is the latest move in Bora’s global expansion march.In June, Bora shelled out $30 million to snap up Emergent’s fill-finish drug product facility in Baltimore that offers clinical and commercial nonviral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services.That acquisition followed January’s $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories that gave Bora a foothold in the U.S.In 2022, Bora purchased fellow Taiwanese company TWi Pharmaceuticals, gaining two manufacturing facilities and some niche technologies, and it also bought Eden Biologics' CDMO business.