Week In Review: Nippon Shinyaku Signs $735 Million Deal For DMD Therapy

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Deals and Financings

Japan’s Nippon Shinyaku (NPPNY) will acquire European rights for a Duchenne muscular dystrophy disease therapy developed by Capricor Therapeutics of San Diego (CAPR) (see story). The agreement comes as no surprise: Nippon Shinyaku has previously signed similar deals for the candidate in the US and Japan.

Capricor’s lead asset, deramiocel, consists of allogeneic cardiosphere-derived cells (CDCs), a population of stromal cells that have lowered inflammation in dystrophy and heart failure. In the latest deal, Nippon Shinyaku will pay $20 million upfront and up to $715 million in milestones, plus royalties. The two companies signed a binding term sheet that will be finalized in Q4.

Shanghai’s Fosun Pharma announced plans to buy out its JV partner, Kite Pharma, gaining full control of the JV’s two CAR-T products in China (see story). In 2017, Fosun paid $95 million for a 50% stake in a JV with Kite that was formed to bring Kite’s lead product, Yescarta, to China.

Now, Fosun will buy out Kite’s 50% stake in the JV for $27 million plus invest $10 million in Fosun Kite. Fosun Kite holds China rights for Yescarta, and it is also developing a second Kite-sourced CAR-T candidate, FKC889 (brexucabtagene autoleucel). Yescarta was China’s first approved CAR-T therapy. 

Organon & Co. (OGN), a women’s health company, acquired China rights to an ovarian stimulation therapy from Shanghai Bao Pharmaceuticals (see story). SJ02 was developed for patients in assisted reproductive programs. The candidate is a long-acting product designed to develop multiple follicles for one week after a single dose, while the current standard of care requires daily shots for a week.

Bao has filed a BLA with China regulators for SJ02. If approved, the candidate will be the first long-acting ovarian stimulation product in China. Organon will pay $12 million upfront for the rights plus unspecified milestone payments. 

Hangzhou Celregen Therapeutics raised “tens of millions RMB” to advance its regenerative medicine and cell therapy products (see story). The company is a subsidiary of Fosun Pharma that was incubated by the New Drug Fund of Fosun Health Capital.

During its corporate life, Celregen has been operating mostly in stealth mode, though two years ago, it briefly surfaced to announce it had in-licensed Greater China rights for a corneal endothelial cell regenerative therapy from Cellusion in a $100 million deal. Fosun’s New Drug Fund also led the latest angel round together with the Jiaxing Chuangyan Fund of Shanghai Creation Investment. 


Clinical Trials

Beijing QL Biopharma broke new ground in the crowded GLP-1 marketplace with news that ZT002 was effective in a once-monthly dosing regimen (see story). In a small Phase I China trial, 20 overweight/obese patients were treated biweekly with either 40 or 80 mg of ZT002.

After a six-week layoff, the 80 mg patients were invited to continue the trial with a 120 mg dose and a once-monthly dosing regimen. Their weight loss improved to 17.1% at 30 weeks. QL will pursue the once-monthly schedule in a China Phase II trial of ZT002, already underway.


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