Fierce Pharma Asia—Enhertu's return; Akeso's highlight; GenScript and Legend's US review

Several Asian biopharma companies garnered significant attention at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. This year's event highlighted breakthroughs in breast cancer treatment, lung cancer therapies, and promising early-stage trials in solid tumor CAR-T therapies, as well as a new international pharma alliance and regulatory scrutiny on Chinese biopharma firms.

Enhertu's Potential in HER2-Ultralow Breast Cancer

AstraZeneca and Daiichi Sankyo's antibody-drug conjugate, Enhertu, known for pioneering the HER2-low breast cancer category, is now being eyed for HER2-ultralow breast cancer treatment. During the ASCO meeting, the companies presented a subgroup analysis from the DESTINY-Breast06 trial that demonstrated a 22% reduction in disease progression or death compared to chemotherapy in HER2-ultralow patients. Although the results were not statistically significant, they sparked discussions about identifying suitable patients. Company executives expressed optimism, while experts remained cautious.

Akeso and Summit's Lung Cancer Drug Outshines Keytruda

Akeso and Summit Therapeutics' ivonescimab gained "explosive" interest at ASCO after outperforming Merck & Co.'s Keytruda in a phase 3 lung cancer trial. The head-to-head study highlighted ivonescimab's superiority in progression-free survival. Merck's Chief Medical Officer, Dr. Eliav Barr, emphasized that overall survival results would be crucial for future assessments. Despite this, the findings generated significant excitement at the conference.

U.S. Lawmakers Eye Chinese Biopharma Companies

Amid an ongoing U.S. biosecurity crackdown, two House lawmakers requested an intelligence briefing on the Contract Development and Manufacturing Organization (CDMO) GenScript and its subsidiary, Legend Biotech. They called for FBI Director Christopher Wray and U.S. Director of National Intelligence Avril Haines to discuss potential security concerns. While no specific allegations were made, the lawmakers stressed the importance of safeguarding U.S. competitiveness.

Promising Results for AbelZeta and AstraZeneca's Solid Tumor CAR-T Therapy

In an early-stage trial, AbelZeta and AstraZeneca's solid tumor CAR-T drug, C-CAR031, showed promising results for patients with advanced hepatocellular carcinoma. Among 23 evaluated patients, 91% experienced tumor size reductions. AbelZeta CEO Tony Liu highlighted that the data provided a compelling proof-of-concept for potentially redefining treatment paradigms in hepatocellular carcinoma and other cancers.

FDA Reprimands China's Hengrui Pharmaceuticals

The FDA issued a Form 483 reprimand to China's Jiangsu Hengrui Pharmaceuticals following a January inspection. The agency cited eight observations, including inadequate sterilization processes and failure to make production records available. Although the company recently faced an FDA rejection on an unrelated approval application, the manufacturing issues were not linked to that decision. The FDA's report was made public this week.

Formation of the Biopharmaceutical Alliance

A new international alliance, including South Korea, Japan, India, and the U.S., has been established to enhance the global pharmaceutical supply chain. Known as the Biopharmaceutical Alliance, the group met in San Diego during the BIO convention. Government officials and industry representatives pledged to collaborate on policies and regulations to support their objectives, according to Yonhap News Agency.

In summary, the ASCO annual meeting showcased significant advancements and challenges in the biopharma sector, with Asian companies playing a pivotal role. From promising new treatments in cancer to international collaborations aimed at strengthening the pharmaceutical supply chain, the event underscored the dynamic and rapidly evolving landscape of biopharma.

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