Daewoong Bio, Inc.

Multinational pharmas' appetite for deals with Chinese biotechs, Enhertu's disappointing sales growth and Samsung Biologics' record quarter made our news this week. Large pharma companies are still looking for deals in China. AstraZeneca and Daiichi Sankyo's antibody-drug conjugate star Enhertu experienced a slow quarter. Samsung Biologics' quarterly revenue crossed the 1 trillion South Korean won mark for the first time. And more.1. Drug giants eye China for deals despite growing Sino-US tensions (Reuters)As Chinese biotechs struggle with raising cash amid tightened initial public offering rules and drug pricing pressures, large multinational companies are taking the opportunity to search for deals despite geopolitical risks. Executives at Bristol Myers Squibb and Sanofi said the companies are looking for bolt-on opportunities and acquisitions, respectively, in China, Reuters reports.2. Enhertu stalls as AstraZeneca, Daiichi navigate 'harder yards' for ADC starCombined Enhertu sales for AstraZeneca and Daiichi Sankyo only grew 1.6% sequentially in the second quarter. AZ attributed the slowdown to destocking of previously built inventory in China and projected a return to more robust growth later this year. But continued penetration in some difficult territories in HER2-low breast cancer and meaningful contribution from a tumor-agnostic indication need to happen.3. Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarterThanks partly to the rollout of biosimilars at its subsidiary Samsung Bioepis, Samsung Biologics saw its quarterly revenue top the 1 trillion South Korean won mark for the first time, reaching 1.16 trillion ($839 million), which marked a 37% increase year over year. The CDMO parent now boasts contracts with 16 of the world’s top 20 drugmakers and expects to open Plant No. 5 in April 2025.4. In Singapore, Pfizer cuts ribbon on $743M extension of API plantPfizer has opened a new part of its active pharmaceutical ingredient plant in Singapore. The new facility took 1 billion Singapore dollars to build and covers 429,000 square feet at Pfizer’s Tuas Biomedical Park site. The facility produces antibiotics and small molecules for cancer and pain. It also has capacity to add new features as needed.5. BeiGene CEO eyes biologics deals for new US innovation center in New JerseyBeiGene debuts $800M biologics plant set to create ‘hundreds’ of jobs in New JerseyBeiGene has opened its first manufacturing facility outside of China. The biologics manufacturing and R&D site, located in Hopewell, New Jersey, includes 400,000 square feet of production space and 125 employees. The plant will support BeiGene’s upcoming launch of Tevimbra, and CEO John Oyler hopes to leverage its biologics know-how to search for deals, including in the ADC space.6. Docs embrace Takeda's Eohilia, creating competition for Sanofi, Regeneron's blockbuster DupixentDoctors are open to using Takeda’s Eohilia, an oral suspension formulation of budesonide, in eosinophilic esophagitis, a Spherix Global Insights survey of 74 U.S. doctors has found. Despite Eohilia’s late entry, “the breadth of patient initiations” for the Takeda drug surpassed that of Sanofi and Regeneron’s Dupixent, Spherix said. Most respondents expect to use the biologic later.Other News of Note:7. Triastek, BioNTech ink $1.2B deal to develop 3D-printed oral RNA therapies (release)8. Innovent bags another phase 3 win in China for next-gen Lilly GLP-1 drug9. FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and more10. Insilico Medicine launches AI assistant for drafting medical research papers11. Korea's Daewoong Bio banned from China drug procurement program after turning down inspection

Daewoong can no longer take part in China's national volume-based procurement program until January 17, 2026. As with GSK before it, Daewoong Bio’s manufacturing misstep has resulted in a ban for the Korean company from China’s bulk-buy drug procurement program. On Thursday, China’s National Medical Products Administration (NMPA) said it’s suspending (Chinese) the import, sale and use of Daewoong’s cephalosporin antibiotic cefodizime sodium for injection after the company declined to participate in an inspection of its production site. As a result, the NMPA determined that Daewoong’s inspection results were “not in compliance with the requirements.” Daewoong’s decision to turn down the inspection further violated China’s Drug Administration Law and Regulations on Overseas Inspection of Drugs and Medical Devices, NMPA added. What’s more, the violation means Daewoong can no longer take part in national volume-based procurement (VBP) activities until January 17, 2026. China’s VBP was set up in 2018 to help cut the costs of off-patent drugs. The scheme requires manufacturers to go through a bidding process to supply products to public hospitals. NMPA is now advising provinces where Daewoong is the main supplier of cefodizime sodium to rely on backup suppliers for stocks of the antibiotic, which is used to treat a variety of bacterial infections and is sometimes given to patients allergic to penicillin. If the backup suppliers cannot meet demand, the provinces can begin the process of adding additional backup suppliers. Daewoong did not immediately respond to Fierce Pharma’s request for comment. The situation in many ways mirrors that faced by GSK when the sale and import of the company’s Avodart soft capsules were banned in China back in October of 2022. The product cull was triggered by an inspection of a facility in Poznan, Poland, where it was found GSK did not conduct batch-by-batch and full-item inspections of Avodart sent to China. As part of the ban for that specific product, GSK was also prohibited from taking part in VBP for 18 months. Prior to that incident, BeiGene’s chemotherapy Abraxane was banned from Chinese import in 2020 after Chinese authorities uncovered shortfalls during an inspection of a Fresenius Kabi plant in Melrose Park, Illinois.