Big pharma’s deals: from Chinese-developed drugs to decades-old partnership
Novartis entered into a global licensing agreement with Suzhou-based Abogen Biosciences on October 2 to develop ABO2203, an investigational mRNA therapy, to complement the Swiss pharma’s treatments for autoimmune diseases. The deal also includes an exclusive option agreement to license other next-generation therapies developed on Abogen’s mRNA platform. ABO2203 is a lipid nanoparticle-formulated mRNA encoding a CD19xCD3 bispecific T-cell engager (TCE). Designed for subcutaneous injection in an outpatient setting, ABO2203 directs the body to produce the B-cell depleting TCE in vivo to provide consistent systemic exposure and avoid the cytokine release syndrome associated with direct infusion of recombinant antibody drugs. It is the first mRNA-encoded TCE to enter clinical evaluations with trials ongoing in refractory autoimmune diseases and relapsed or refractory B-cell Non-Hodgkin Lymphoma in China. Other mRNA-encoded polyspecific TCE under development include BioNTech’s CD3xCLDN6 bispecific TCE (BNT142) and Moderna’s multiplexed mRNA platform encoding three distinct bispecific TCEs that target multiple myeloma antigens BCMA, FcRH5, and GPRC5D (mRNA-3xTCE).
Novo Nordisk is paying Jiangsu Hengrui Pharmaceuticals $300 million upfront to license HRS-1596, a potential once-weekly oral weight-loss medication, in a deal announced on September 29. The agreement gives Novo rights to develop, manufacture, and commercialize the drug outside the greater China region with potential milestone payments up to $2.3 billion. Like Eli Lilly’s Zepbound, HRS-1596 is a dual agonist of GLP-1 and GIP receptors. It is designed to suppress appetite, stimulate insulin secretion, and improve insulin sensitivity for treating obesity, type 2 diabetes, and other cardiometabolic diseases. Hengrui has received the green light in China to begin phase 1 clinical trials for weight management and type 2 diabetes. If once-weekly oral administration proves successful, it would significantly reduce dosing frequency and improve convenience, helping Novo gain ground in GLP-1/GIP obesity drug market against competitors like Zepbound, which is injection only, and Viking Therapeutics’ VK2735, which is a once-daily oral tablet in phase 3 developments.
AstraZeneca completed a $2 billion equity investment in Summit Therapeutics on October 5. The companies will collaborate in the development of Summit’s ivonescimab, a potential first-in-class bispecific antibody targeting PD-1 and VEGF, in combination with AstraZeneca’s sonesitatug vedotin (sone-ve), an experimental antibody drug conjugate (ADC), and other ADCs across a number of solid tumors. Developed by Akeso Inc headquartered in Zhongshan, ivonescimab outperformed Merck’s blockbuster PD1 inhibitor Keytruda in preventing disease progression or death as a monotherapy in first-line treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer in a phase 3 trial in China. Its tetravalent bispecific design enables higher T-cell avidity in the tumor microenvironment (TME). Licensed from China-based KYM Biosciences, sone-ve is a CLDN18.2-targeting ADC with a monomethyl auristatin E (MMAE) payload. It met its primary overall survival endpoint in previously treated CLDN18.2-positive advanced gastric cancers in a global phase 3 trial. The partnership is the latest among a flurry of high-profile deals in the increasingly crowded PD-1xVEGF bispecific antibody space, where global pharma companies have been securing drugs that are often developed by Chinese biotech companies, for example, in Merck’s licensing of LaNova’s LM-299, Pfizer’s licensing of 3SBio’s SSGJ-707, and BMS and BioNTech’s deal involving BNT327, which was originally developed by Biotheus.
Sanofi is expanding its 23-year alliance with Regeneron that produced Dupixent in an agreement worth up to $8 billion including a $1 billion upfront payment to advance four next-generation long-acting antibodies targeting type 2 inflammation. With profits equally split between the two, Regeneron will spearhead the development of the four candidates, including REGN20423, an IL-13 monoclonal antibody in phase 1 clinical trial in treating atopic dermatitis, an IL-4xIL-13 bispecific antibody and two other preclinical candidates. Sanofi will lead the global commercialization efforts. With Dupixent’s key patent set to expire in 2031, the partners are joining forces again in the fight against type 2 inflammation, hoping to replicate the blockbuster’s success.
[This post is for educational purposes only. It reflects my own analysis of publicly available information, does not constitute legal advice, and does not create an agent-client relationship. Views expressed are my own, not those of any employer or client.]
