Pharmaceutical Industry Roundup: Major Deals, Clinical Wins, and Global Expansion

Pfizer and RemeGen's HER2 ADC Shows Promise in Bladder Cancer

Pfizer and RemeGen have reported positive phase 3 results for their HER2 antibody-drug conjugate (ADC), disitamab vedotin, in a Chinese trial for first-line HER2-expressing bladder cancer. The ADC, combined with Junshi Biosciences' PD-1 inhibitor toripalimab, outperformed chemotherapy regardless of patients' cisplatin eligibility or HER2 expression levels. This success bodes well for Pfizer's global DV-001 study, also known as Keynote-D74.

Roche Invests $282 Million in New Chinese Vabysmo Plant

Roche has announced plans to invest approximately 2 billion Chinese yuan ($282 million) in a new biologics plant in Shanghai. The 25,000-square-meter facility will primarily produce the eye medication Vabysmo for the domestic market. Construction is expected to be completed by 2029, with production potentially beginning in 2031.

Major Financial Moves: Hengrui's IPO and Qilu's ADC Deal

China's pharmaceutical landscape is witnessing significant financial activity. Jiangsu Hengrui Pharmaceutical is planning to raise up to HK$9.89 billion ($1.27 billion) in a Hong Kong IPO, offering 224.52 million shares priced between HK$41.45 and HK$44.05 each. The company expects to finalize pricing by May 21 and commence trading on May 23.

In a separate development, Qilu Pharmaceutical has agreed to pay 280 million Chinese yuan ($38 million) upfront for greater China rights to Minghui Pharmaceutical's B7-H3 ADC, MHB088C. This deal follows a trend of B7-H3 ADC partnerships, including Merck & Co.'s licensing of ifinatamab deruxtecan from Daiichi Sankyo, GSK's acquisition of a candidate from Hansoh, and BioNTech's collaboration with Duality Bio.

Regulatory Approvals and Patent Disputes

Despite an ongoing patent infringement lawsuit from Ipsen, CSPC Pharmaceutical has licensed its irinotecan liposome injection to Cipla for the U.S. market. The deal includes a $15 million upfront payment, with potential milestone payments exceeding $1 billion. Ipsen alleges that CSPC's candidate infringes on a patent for its irinotecan liposome product, Onivyde.

In China, Novartis has secured approvals for two cancer drugs. Kisqali has been approved for the adjuvant treatment of early-stage HR-positive, HER2-negative breast cancer, while Scemblix received clearance for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia. Both indications are considered major growth drivers for the Swiss pharmaceutical company and have already been approved in the United States.