Irinotecan Hydrochloride Lioposome (Ouyi)

Positive data from a Pfizer-partnered antibody-drug conjugate, Roche's new investment in China and Hengrui's upcoming dual listing in Hong Kong made our news this week. Pfizer and RemeGen's HER2 antibody-drug conjugate delivered positive phase 3 results in a bladder cancer trial in China. Roche plans to invest nearly $300 million to build a new Chinese plant to produce Vabysmo. China's Hengrui Pharma is looking to raise up to $1.27 billion in its Hong Kong IPO. And more.1. Pfizer partner RemeGen says HER2 ADC prolongs life in newly diagnosed bladder cancerRemeGen’s Pfizer-partnered HER2 antibody-drug conjugate, disitamab vedotin, was successful in a phase 3 study among Chinese patients with first-line HER2-expressing bladder cancer. The ADC, used alongside Junshi Biosciences’ PD-1 inhibitor toripalimab, outperformed chemotherapy regardless of patients' eligibility for cisplatin or HER2 expression levels. The trial win bodes well for Pfizer’s global DV-001 study, also called Keynote-D74.2. Roche pledges nearly $300M to establish new Vabysmo production plant in ChinaRoche is investing about 2 billion Chinese yuan ($282 million) to build a new biologics plant in Shanghai. The plant will occupy about 25,000 square meters (269,000 square feet) of real estate and will mainly be used for domestic production of the eye med Vabysmo. Construction is expected to finish in 2029, and production could kick off by 2031, according to Roche.3. Hengrui looks to raise up to $1.27B in Hong Kong IPO (Morningstar)Jiangsu Hengrui Pharmaceutical, already listed in Shanghai, is planning to raise up to HK$9.89 billion ($1.27 billion) in a Hong Kong IPO. The plan involves selling 224.52 million shares at a price range of HK$41.45 to HK$44.05 each. The Chinese pharma giant expects to finalize pricing by May 21 and start trading from May 23.4. Qilu Pharmaceutical pays $38M upfront for greater China rights to Minghui's ADCThe B7-H3 target has yielded another deal. Qilu Pharmaceutical is paying 280 million Chinese yuan ($38 million) upfront for greater China rights to Minghui Pharmaceutical’s B7-H3 ADC, MHB088C. Also in the B7-H3 ADC field, Merck & Co. has licensed ifinatamab deruxtecan from Daiichi Sankyo, GSK got a candidate from Hansoh and BioNTech partnered with Duality Bio.5. CSPC licenses Onivyde copycat to Cipla despite Ipsen patent dispute (release, PDF)Despite a pending patent infringement lawsuit from Ipsen, CSPC Pharmaceutical has penned a deal to license its irinotecan liposome injection in the U.S. to Cipla for $15 million upfront. Milestone payments from the pact could exceed $1 billion. In a lawsuit filed in August 2024, Ipsen alleges that the CSPC candidate infringes a patent for the French pharma’s irinotecan liposome product Onivyde.6. Novartis cancer drugs Kisqali, Scemblix win China approvals (releases, Chinese)In two approvals for Novartis’ business in China, local authorities approved the company’s Kisqali for the adjuvant treatment of early-stage HR-positive, HER2-negative breast cancer, as well as Scemblix for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia. Both indications have been cleared in the U.S. and are considered major growth drivers for the Swiss pharma.Other News of Note:7. Merck KGaA drops China surcharge on orders after US-China tariff deal (Reuters)8. Sino-American siRNA biotech Sirius Therapeutics raises $50M (release)