(Yicai) April 13 -- China has given the green light to the 13th innovative drug since the start of the year, while multinational pharmaceutical firms have been diversifying their local collaboration models amid the country continually strengthening support for such treatments and the increasing global recognition of its innovation capabilities.

BeOne Medicines' tarlatamab, a small-cell lung cancer treatment, has received conditional approval from the National Medical Products Administration through the priority review process, the company announced on April 10. Sold under the brand name Imdelltra, it is developed and commercialized in the Chinese mainland by BeOne in collaboration with US biopharmaceutical firm Amgen.

The 13 innovative drugs approved for marketing by the NMPA this year range from anti-tumor treatments to blood sugar and lipid-lowering therapies, including six first-in-class drugs. The regulator has accelerated relevant market entry processes by utilizing priority review and approval, conditional market authorization, breakthrough therapy designation, and other mechanisms.

Imdelltra is the world's only bispecific T-cell engager antibody targeting delta-like ligand 3 and cluster of differentiation 3. Its approval introduces a new targeted immunotherapy with novel targets and mechanisms for the treatment of solid tumors in China.

Imdelltra could generate annual sales of USD2 billion for California-based Amgen after its launch in China, according to Wall Street analysts.

China continues to achieve historic breakthroughs in innovative drug development, with Chinese drugmakers signing relevant out-licensing agreements worth over USD60 billion in the three months ended March 31, almost half of last year's total, according to the latest statistics from the NMPA.

In comparison, more than 150 innovative drug out-licensing agreements worth over USD130 billion were signed last year, both achieving new records, according to the NMPA. The agency also approved a record high of 76 such drugs.

In addition, the collaboration models of multinational pharmaceutical companies in China have moved beyond just licensing.

For example, Zai Lab and Amgen agreed for the Chinese innovative biotech firm to retain full ownership of its cancer drug Zocilurtatug while supplying clinical trial drugs to the US pharmaceutical giant. This model leverages the pair's drug advantages to achieve greater therapeutic efficacy.

The accelerated approval of Amgen's drug for treating small-cell lung cancer by Chinese regulators is very important, Josh Smiely, president of Zai Lab, told Yicai. The Shanghai-based firm is working on the enrollment for a global Phase III clinical trial for the DLL3 antibody–drug conjugates Zocilurtatug, which includes participants who have experienced disease progression after treatment with Tarlatamab, he added.

Zai Lab will announce the latest data from the clinical study of the potential therapy combining Zocilurtatug with Tarlatamab later this year, Smiely noted.

Editor: Martin Kadiev