Fangda represented CSPC in signing an exclusive license agreement with Jiangsu Alphamab for the development and commercialization of JSKN003 in mainland China

On 29 September 2024, CSPC Pharmaceutical Group Limited (1093.HK, “CSPC”) announced that, Shanghai JMT-BIO Technology Co., Ltd (“JMT-BIO”), a wholly-owned subsidiary of CSPC, has entered into an exclusive license agreement (the “Agreement”) with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”) to develop, sell, offer for sale and commercialize JSKN003 (a biparatopic HER2-targeting antibody-drug conjugate (“ADC”)) (the “Product”), for the treatment of tumor-related indications (the “Field”) in mainland China (excluding Hong Kong, Macau or Taiwan) (the “Territory”).

According to the terms of the Agreement, JMT-BIO will obtain the exclusive license and sublicense rights (the “License”) to develop, sell, offer for sale and commercialize the Product, bear all costs associated with the clinical development activities and become the sole marketing authorization holder (MAH) for the Product for the Field in the Territory.

As consideration for the License, JMT-BIO agreed to pay Jiangsu Alphamab an upfront payment of RMB400 million and development and regulatory milestone payments of up to RMB830 million, subject to the development progress of the Product in the Territory. JMT-BIO also agreed to pay Jiangsu Alphamab potential sales milestone payments of up to RMB1.85 billion, and tiered royalties of double-digit percentage based on net sales of the Product for the Field in the Territory.

The Product, JSKN003, is a biparatopic HER2-targeting ADC, of which a topoisomerase I inhibitor is linked to the N-glycosylation site of the antibody KN026 (a recombinant humanized antiHER2 bispecific antibody) via the glycosite-specific conjugation. The click reaction-based conjugation confers better serum stability than maleimide-Michael reaction-based conjugation. The biparatopic HER2 targeting enables the Product to have a stronger internalization induction and bystander killing effect, leading to potent anti-tumor activity in HER2 expression tumors. Currently, a phase I clinical study in Australia, phase I/II and phase III clinical studies in China of JSKN003 are undergoing.

The Fangda team provided comprehensive legal services to CSPC. The team was led by Corporate partners Josh SHIN and Henry HE in transaction structures design, transaction documents negotiations and revisions. Team members included counsel Muriel HE, associates Audrey LUO, Xiaoyan LIANG and Essie ZHAO.