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)

3月28日，石药集团发布2024年业绩，2024全年营收290.1亿元人民币，同比减少7.8%，全年净利润43.3亿元人民币，同比减少26.3%。其中，成药业务于2024年度取得收入人民币237.36亿元（包括授权费收入人民币1,783万元），较去年减少7.4%，以下为按主要治疗领域的销售情况：石药集团在年报中表示，2024年，药品集中采购带来的压力尤为显着。石药集团的津优力®（聚乙二醇化重组人粒细胞刺激因子注射液）和多美素®（盐酸多柔比星脂质体注射液）两款产品在京津冀「3+N」联盟药品集中采购中，价格分别下调了约58%和23%。随着集采结果自2024年3月份起陆续在各相关省份执行，这两个产品的收入出现了大幅下滑。然而，石药集团近年来新增的多个产品，如明复乐®（注射用重组人TNK组织型纤溶酶原激活剂）、多恩益®（盐酸伊立替康脂质体注射液）、多恩达®（盐酸米托蒽醌脂质体注射液）、意舒宁（®硝苯地平控释片）、戈瑞特（®甲磺酸仑伐替尼胶囊）及恩理维（®拉考沙胺注射液/片）均能快速增长，为公司带来了可观的销售贡献。在业务拓展方面，石药集团2024年完成了一个项目的许可引进和三个对外许可项目。在许可引进方面，石药集团获得了江苏康宁杰瑞授权的JSKN003（一种靶向HER2双表位ADC）在中国大陆的开发和商业化权利。在对外许可方面，石药集团与国际知名药企达成了合作协议，包括将一款临床前阶段的Lp(a)小分子抑制剂的全球权益授权给阿斯利康、将新型甲硫氨酸腺苷转移酶2A(MAT2A)抑制剂的全球权益授权给百济神州，以及将抗体偶联药物SYS6005包括美国和英国在内多个国家的开发及商业化权益授权给RadianceBiopharma,Inc.。目前，石药集团在研创新药和创新制剂200余项，其中大分子90余项，小分子60余项，新型制剂–8–50余项；有160余个临床试验正在进行中，三期临床试验近60项，预计截止2028年底，将有50余款新药/新适应症申报上市。