China's anti-graft watchdog is investigating Bi Jingquan, the former head of the China Food and Drug Administration. Daiichi Sankyo, along with partner Merck & Co., has pulled an FDA approval filing for an antibody-drug conjugate cancer prospect. Novartis expanded a commercial collaboration with Shanghai Pharma. Plus more.
1. China investigating former head of food and drug watchdog (Reuters)
Bi Jingjuan, the former head of the China FDA, is under investigation in the country for suspected corruption, the Central Commission for Discipline Inspection announced (Chinese) Thursday. Bi was appointed to the CFDA in 2015 and is credited for the country's efforts to streamline drug approvals. In 2018, the CFDA was renamed the National Medical Products Administration as part of a government overhaul.
2. Daiichi, Merck pull HER3-DXd filing at FDA after confirmatory trial misses survival endpoint
Even though a phase 3 trial for Daiichi Sankyo and Merck & Co.'s patritumab deruxtecan hit its primary endpoint of progression-free survival, the trial failed to show a statistically significant benefit in overall survival. This result prompted the partners to pull a biologics license application for the drug as a potential treatment for certain adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer. The drug previously suffered an FDA rejection last year.
3. Novartis expands strategic collaboration with Shanghai Pharma in China to cover eye drugs
As Novartis works to become a top 3 multinational drugmaker in China by sales, the company has enlisted Shanghai Pharma to grow the reach of certain drugs for ocular infections and glaucoma. Last year, Novartis signed on Shanghai Pharma to help build a local supply chain for radioligand therapies. As for Shanghai Pharma, the company is one of the largest pharma distributors and contract sales organizations (CSOs) in the country. Its CSO unit managed 65 drugs last year, contributing around 8 billion Chinese yuan ($1.1 billion) toward those medicines' global sales.
4. Drugmakers, trade groups and others voice concerns with pharma-specific tariffs
As the Trump administration weighs sector-specific tariffs with a Section 232 investigation into pharmaceuticals, the Chinese government and the China Chamber of Commerce for Import & Export of Medicines & Health Products offered their thoughts during the public comment process. In its comment, the Chinese government asserted that since 2017, the U.S. has "continuously extended the concept of ‘national security,’ using it as a pretext to launch Section 232 investigations to impose trade protectionist measures" in various industries. Besides the Chinese government, several other entities opposed potential pharma-specific tariffs.
5. Sanofi eyes vaccine manufacturing in Vietnam amid tech transfer with local firm
Sanofi has initiated a tech transfer process with the Vietnam Vaccine Company (VNVC) with the goal to eventually produce certain Sanofi vaccines in the country. As part of the collaboration, Sanofi will also help the VNVC with human resources training and quality management linked to vaccine research and production. Besides the Sanofi project, the VNVC revealed that it will be building a new 26,000-square-meter (279,862-square-foot) production facility in the Long An province in Vietnam.
Other News of Note:
6. Biotech incubated by TCG Labs inks $210M deal for EpimAb's T-cell engager
7. AACE Pharma slammed with FDA warning letter for contract manufacturer's shortfalls