Latest news with #drug approvals
South China Morning Post
24-07-2025
- Business
- South China Morning Post
China approving innovative drugs at record pace as discovery momentum shifts from West
China is making inroads in the race for innovative pharmaceuticals, with a record number of drug approvals this year amid growing appeals for multinational giants to run onshore research entities. Authorities approved 43 innovative drugs in the first half of 2025, marking a 59 per cent year-on-year increase and nearly matching the total of 48 approvals for all of last year, state broadcaster CCTV reported on Wednesday, citing data from the National Medical Products Administration (NMPA). Many of the 43 innovative drugs approved for market launch are for serious conditions such as cancer, metabolic disorders and immune diseases, the report said. 'China's reform of drug review and approval processes has enabled pharmaceutical companies to better forecast their returns on R&D investments … making them more willing to pursue long-term, high-risk innovative drug development,' said Yang Ting, director of the NMPA's drug registration department, in an interview with CCTV. China is the world's second-largest biomedicine market, and global players have been increasingly expanding their presence there. Also in the year's first half, China set a record for licensing out innovative drugs – referring to rights granted to overseas markets – with a total value of US$48.4 billion, according to figures from mainland pharmaceutical consultancy DrugTimes. To further refine manufacturing processes and improve drug quality, additional approval procedures are often required after a drug's market launch.
Yahoo
22-07-2025
- Business
- Yahoo
FDA Rejects Replimune's Skin Cancer Treatment, Shares Sink
(Bloomberg) -- US regulators rejected a skin cancer treatment from Replimune Group Inc. in another sign of the agency's new leadership taking a hard line on drug approvals. Why the Federal Reserve's Building Renovation Costs $2.5 Billion Salt Lake City Turns Winter Olympic Bid Into Statewide Bond Boom Milan Corruption Probe Casts Shadow Over Property Boom How San Jose's Mayor Is Working to Build an AI Capital The US Food and Drug Administration denied the company's application to treat advanced melanoma with a combination of its immunotherapy and another cancer drug. The agency said the company's trial 'is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,' Replimune said in a statement on Tuesday. The FDA also had issues with the company's trial design and patient population. The company's shares plunged as much as 79% in premarket trading. The company said the issues were not raised by the agency during prior reviews and it plans to 'urgently interact with the FDA to find a path forward.' In a note, BMO Capital Markets analyst Evan Seigerman called the FDA rejection 'the worst case scenario' for Replimune and it appeared that the new FDA leadership had a late change of opinion. 'This potential last minute change points to a changing tone at the agency, which is placing a greater emphasis on randomized controlled trials regardless of the patient population and availability of alternative treatment options,' Seigerman wrote. Vinay Prasad, the FDA's new chief medical and scientific officer, has previously been critical of approving drugs based on uncontrolled data, he said. In recent days, the FDA has also rejected treatments from Capricor Therapeutics Inc. and Ultragenyx Pharmaceutical Inc. and requested that Sarepta Therapeutics Inc. halt shipments of its gene therapy after recent patient deaths. Elon Musk's Empire Is Creaking Under the Strain of Elon Musk A Rebel Army Is Building a Rare-Earth Empire on China's Border Thailand's Changing Cannabis Rules Leave Farmers in a Tough Spot How Starbucks' CEO Plans to Tame the Rush-Hour Free-for-All What the Tough Job Market for New College Grads Says About the Economy ©2025 Bloomberg L.P. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
