Eyes on Asia: BIOSECURE, Merck & Hansoh, Roche adds ADC, and Samsung

BIOSECURE Act

Having had 12 months of political insecurity courtesy of the US BIOSECURE Act, 2025 has seen the beginning of upheaval in China’s contract manufacturing space.

The Act, introduced in January 2024, aimed to block “foreign adversary biotech companies of US national security concern,” naming such big players as BGI Group, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics. The bill achieved broad bipartisan support and passed with a 306 to 81 vote in the US House of Representatives back in September, triggering rumors that non-China based assets run by these companies could be divested.

And such rumors have come to pass… to an extent. WuXi AppTec has announced a deal to sell its Advanced Therapies Unit (ATU) to Altaris for an undisclosed fee. The US-based investment firm will pick up a late phase/commercial viral manufacturing facility, a testing laboratory, a non-viral cell therapy plant, and a process development/early phase clinical manufacturing site, all in Philadelphia, Pennsylvania. It will also add capabilities in Oxford, UK inherited from WuXI AppTec’s $135 million acquisition of Oxgene in 2021. 

Meanwhile, WuXi Biologics is set to sell an Ireland vaccines manufacturing plant run by its joint venture WuXi Vaccines to its sole client, Merck & Co. (known as MSD outside of North America), who inked a 20-year $3 billion deal with the contract development and manufacturing organization (CDMO) back in 2019.

However, Jefferies analyst Cui Cui said in a note this sale is less to do with BIOSECURE and more because the facility “no longer meets Wuxi Bio's ROI [return on investment] standards.” In fact, Cui questions whether BIOSECURE – which was excluded from the US defense spending bill in December, causing WuXi Apptec and WuXi Biologics shares to spike – will actually come to fruition under the incoming Trump administration.

“Senator Rand Paul (Republican, Kentucky), a key opponent of the BIOSECURE Act, is set to chair the Homeland Security Committee under the Trump presidency, whereas key supporter Brad Wenstrup is retiring,” he wrote.

“Moreover, many believe Trump’s government will likely be more business-oriented and that usage of Chinese CDMOs could help US pharma cut costs by 30-60%. Given lowering drug prices in the US is supported by both parties, allowing US pharma companies the flexibility to operate efficiently and maintain an optimal cost structure is essential.”

Merck and Hansoh

Over to dealmaking, and the aforementioned Merck & Co. has entered into an exclusive global license agreement with China’s Hansoh Pharma for preclinical candidate HS-10535.

Merck will pay Hansoh $112 million upfront, though the Chinese firm, which retains the rights to the candidate in China, could receive up to $1.9 billion in milestone payments and royalties.

“Through this agreement, we aim to build on our experience targeting incretin biology to evaluate HS-10535 and its potential to provide additional cardiometabolic benefits beyond weight reduction,” Dean Li, president of Merck Research Laboratories said.

HS-10535 is an oral version of a small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1s represent the current wave in blockbusters, specifically for diabetes and weight loss (though other indications are being investigated).

The modality has been driving the toplines for pioneers Novo Nordisk and Eli Lilly, though other Big Pharma firms are looking to join the party through licensing deals. For Merck, the Hansoh deal brings a second GLP-1 into its pipeline, having forged a partnership with Korea’s Hanmi Pharma in 2020 to codevelop efinopegdutide for the treatment of nonalcoholic steatohepatitis (NASH).

Hansoh itself has a history of collaborating with Western pharma firms, with the firm inking with two billion-dollar-plus antibody drug conjugate deals with GSK in 2023.

Roche and Innovent

And talking of ADCs, fellow Big Pharma firm Roche has also been busy partnering in China, entering a collaboration with Suzhou-headquartered Innovent Biologics to develop DLL3-targeted candidate IBI3009.

Roche, which is no stranger to ADC development with two products – Polivy (polatuzumab vedotin) and Kadcyla (trastuzumab emtansine) – on the market, will pay $80 million upfront though Innovent could receive up to $1 billion depending on development success.

“We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer,” said Boris Zaïtra, head of Corporate Business Development at Roche, said. “This partnership builds on Roche's long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumors with transformational medicines."

Having shown encouraging anti-tumor activity in multiple tumor-bearing mouse models, IBI3009 entered into a Phase I study for small cell lung cancer began in December.

Samsung Life Science Fund

Over to Korea, and the Samsung Life Science Fund – a venture investment fund jointly established by Samsung C&T Corporation and its subsidiaries Samsung Biologics and Samsung Bioepis – has pledged to invest KRW 240 billion ($165 million) in Generate Biomedicines, a US-based biotech venture aimed at developing new technologies and businesses in life sciences.

Specifically, Generate Biomedicines focuses on protein design technologies using generative artificial intelligence (AI) and machine learning. The venture is also developing large-scale data accumulation capabilities to improve AI model performance and boost the success rate of novel drug development.

“We have recognized Generate Biomedicine’s potential to develop groundbreaking treatments,” John Rim, CEO of Samsung Biologics, told Korean outlet The Bio. “We look forward to leveraging their expertise in AI and machine learning to build a collaborative ecosystem in development, manufacturing, and R&D, advancing the next-generation pharmaceuticals that our customers need.”

Generate Biomedicine plans to launch three to six clinical programs over the next 18 months.