A 'poster child' for Chinese biopharma wins US approval for new cancer therapy

The US Food and Drug Administration on Wednesday approved a cancer drug developed by China-based Akeso Inc, marking a milestone in the nation's fast-growing biotechnology realm and a first for this company seeking to compete globally in cutting-edge cancer research.

The drug, called penpulimab-kcqx, will be used in combination with chemotherapy to treat adults with advanced nasopharyngeal carcinoma, an aggressive, hard-to-treat cancer that affects the head and neck.

The FDA approval comes at a time of heightened trade tensions between China and the United States. While US authorities are tightening export controls and mulling new restrictions on biotech-related transactions with China, Akeso's clinical success signals that scientific excellence may still transcend political headwinds – at least for now.

"This approval provides a vital new option for US patients with advanced nasopharyngeal carcinoma and validates the quality of our innovation," said Dr Xia Yu, founder and chief executive of Zhongshan-based Akeso. "It also marks our first international regulatory breakthrough and a step toward bringing Chinese innovations to the global stage."

The FDA's decision comes on the back of robust clinical data demonstrating the efficacy and safety of penpulimab-kcqx when combined with cisplatin or carboplatin and gemcitabine.

Hu Chaosu, a professor at the Fudan University Shanghai Cancer Center and a principal investigator in clinical trials, said the approval would "enhance international treatment guidelines for advanced nasopharyngeal carcinoma and extend the benefits of China's innovations to global patients."

Investors are equally impressed. Akeso's Hong Kong-listed shares have risen about 20 percent in the last week.

Nasopharyngeal carcinoma is a rare form of cancer, with higher prevalence in eastern and southeastern Asia. Treatment options remain limited, making the availability of a new immunotherapy-backed regimen particularly meaningful.

Akeso's achievement also signals intensifying competition in the so-called "PD-1/PD-L1 immunotherapy" space, long dominated by Western pharmaceutical giants.

In a separate program, Akeso's invonescimab, a PD-1/VEGF bispecific antibody for treatment of "non-small cell" lung cancer, recently outperformed Merck & Co's Keytruda in Phase III trials conducted in China. That data made waves globally, signaling that Chinese drugmakers are no longer just fast followers but now leaders in certain research.

Through a licensing deal with US-based Summit Therapeutics, Akeso aims to market ivonescimab in the United States, Europe and Japan. Akeso retains commercial rights in China and Australia. The partnership with Summit is widely seen as a strategic move to navigate regulatory and geopolitical complexities while challenging Keytruda's global dominance.

Despite escalating rhetoric around biopharma decoupling, Akeso's international strategy highlights an increasingly nuanced reality: scientific partnerships, clinical data and regulatory trust can still serve as bridges across strained US-China relations. The company's focus is on novel biologics rather than on the raw materials of drugs, a category more vulnerable to tariffs.

Founded in 2012, Akeso specializes in innovative immunotherapies, including a pipeline of over 50 innovations targeting oncology and autoimmune diseases. Its products are listed on China's National Reimbursement Drug List, and several are advancing through global clinical trials.

The company's emphasis on speed, scientific rigor and dual-market strategies has made it a poster child for the emergence of China biotech.

"The FDA approval of penpulimab-kcqx "positions China's innovative drug development in alignment with international standards," said Chen Xiaozhong, a professor at Zhejiang Cancer Hospital and another lead investigator in the program.

As Akeso prepares for broader marketing of penpulimab-kcqx in the US, it is also planning to expand the global reach of other pipeline candidates.

Its success joins Junshi Biosciences and BeiGene, two other leading Chinese biopharmaceutical companies that have also made significant advances into the US PD-1/PD-L1 immunotherapy market through FDA approvals and strategic partnerships.