Pharmaceutical Executive Daily: GSK Enters Collaboration to Support Launch of Bepirovirsen

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, GSK enters an exclusive collaboration with Sino Biopharmaceutical's CTTQ subsidiary to accelerate the launch of bepirovirsen, the FDA approves Bizengri under the Commissioner's National Priority Voucher program, and President Trump has signed off on a plan to fire FDA Commissioner Marty Makary.

GSK has entered into an exclusive strategic collaboration with Chia Tai Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharmaceutical, to support the commercial launch of bepirovirsen in mainland China, where the drug is currently under priority regulatory review for chronic hepatitis B. Under the terms of the initial 5.5-year agreement, CTTQ will handle importation, distribution, hospital access, and promotional activities across a network of more than 5,000 medical centers, while GSK retains the marketing authorization and oversight of regulatory, quality, pharmacovigilance, and global medical strategy, with GSK booking sales of bepirovirsen supplied to CTTQ.

The FDA has approved Bizengri, a HER2 and HER3-directed bispecific antibody developed by Partner Therapeutics for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion whose disease has progressed on or after prior systemic therapy, marking the first targeted therapy approved specifically for this rare molecular subset of bile duct cancer. The approval, the seventh granted under the FDA Commissioner's National Priority Voucher pilot program, was issued on May 8, just two days after Partner Therapeutics received the voucher, and was supported by data from 19 evaluable patients in the open-label Phase 1/2 eNRGy trial, which demonstrated meaningful tumor responses and durable benefit with a favorable tolerability profile.

Finally, President Trump has signed off on a plan to fire FDA Commissioner Marty Makary. The decision follows a turbulent 14-month tenure marked by unexpected drug rejections, high-profile staff departures, reported leadership infighting, and a series of political confrontations with the White House, most recently over Makary's reluctance to fast-track approval for flavored nicotine e-cigarettes, a product Trump had pledged to protect during his 2024 campaign.

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