In a deal worth up to $1 billion, Ideaya Biosciences Inc. is in-licensing Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s SHR-4849, a phase I DLL3-targeting topoisomerase-I payload antibody-drug conjugate. Under terms of the deal, San Francisco-based Ideaya will develop and commercialize SHR-4849 worldwide outside of greater China, and Shanghai-based Hengrui is eligible to receive up to $1.04 billion that includes a $75 million up-front fee, $200 million in development and regulatory milestone payments, and commercial success-based milestone payments. Hengrui is also eligible to receive royalties on net sales outside of greater China.

Pipeline adjustment by Pyxis highlights head and neck cancer efforts

Pyxis Oncology Inc. has reaffirmed its commitment to phase I-stage antibody-drug conjugate PYX-201 in solid tumors. The compound has shown promise in head and neck squamous cell carcinoma, a space where developers aplenty remain busy. In December, the firm reprioritized its pipeline to concentrate on the first-in-concept approach with the compound, a microtubule inhibitor (optimized auristatin) payload that uniquely targets extradomain-B fibronectin, a noncellular structural component within the tumor extracellular matrix. A two-part series is examining the space.

New year, new five-year mandate, to make Europe more competitive

As 2025 gets underway, a new European Commission will start work on its new five-year mandate, with plans for multiple pieces of legislation that have implications for biotech and pharma – and the life sciences industry more broadly – due to be put forward. Along with sector-specific issues, such as the proposal for a Biotech Act, a European Life Sciences strategy and a Critical Medicines Act, the industry will be faced with cross-sector policies that are intended to improve Europe’s competitive standing. These are in areas including the use of AI tools to improve productivity; the creation of a standardized legal structure for companies no matter where in Europe they operate; moves to improve access to capital for the formation and scale-up of science-based companies; and a European Innovation Act to strengthen the system for translating research to market.

Biontech’s $1.2B vaccine royalty settlement clears path forward

Biontech SE agreed to pay up to nearly $1.259 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccines Biontech partnered with Pfizer Inc. The settlements, disclosed in SEC filings Friday, include amended license agreements for sales going forward. According to the 6-K forms Biontech filed, Pfizer will reimburse the Mainz, Germany-based company for up to $534.5 million of the claimed royalties for 2020-2023 vaccine sales.

Major 2024 licensing deals confirm Asia’s ascent from copier to innovator

From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September. The last two years have been particularly challenging in China, with health care investment down 70% and foreign investment down 90%, said CEC Capital Group founding partner Irene Hong. IPOs on the Hong Kong market have been weak and geopolitical issues are getting more challenging, and investors are tightening their belts and figuring out where to hedge their bets. Even so, Asia has contributed 25% of licensing deals to the global market, which reflects an increasing trust in products and data generated in Asia.

Ausperbio bags $73M series B for hep B-targeting RNA therapy

Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide (ASO) candidate as a functional cure for chronic hepatitis B (CHB). Hangzhou, China- and San Franscisco-based Ausperbio said Dec. 26 that it nabbed $73 million in a series B financing round to fund China and global trials of AHB-137, its novel unconjugated ASO developed with the company’s Med-Oligo ASO technology platform. China’s National Medical Products Administration granted breakthrough therapy designation to AHB-137 in July 2024, when Ausperbio reeled in $37 million in a series A financing round to advance the candidate.  

November's phase III successes; Syros, Cassava tumble on misses 

In November 2024, BioWorld tracked 180 clinical trial updates, down from 219 in October and 252 in September but up from 92 in August. The month included 13 successful phase III outcomes and five trial failures. Among the failures were Syros Pharmaceuticals Inc., which faced a significant setback as its phase III trial of tamibarotene, an oral retinoic acid receptor alpha agonist, failed to meet the primary endpoint of complete response in myelodysplastic syndrome patients with RARA gene overexpression. And data from Cassava Sciences Inc.’s Rethink-ALZ trial of simufilam in patients with mild to moderate Alzheimer’s disease did not show a significant reduction in cognitive or functional decline vs. placebo and failed to meet each of the prespecified co-primary endpoints.

Also in the news

Argenx, Assembly, Astellas, Ausperbio, Axcelead, Beigene, Coeptis, Exicure, GPCR Therapeutics, Hyloris, Northwest, Takeda, Tscan, Viracta, Vor, Wuxi Apptec