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In 2023, China has approved its 13th innovative drug, reflecting the country’s increasing support for cutting-edge healthcare solutions and its rising prominence in pharmaceutical innovation. International pharma companies are expanding their local partnership models as a response to these developments.
BeOne Medicines announced on April 10 that its small-cell lung cancer treatment, Tarlatamab, received conditional approval from the National Medical Products Administration through a priority review process. Marketed as Imdelltra in China, this drug was developed and brought to market in partnership with Amgen, a US-based biopharmaceutical company.
This year’s list of approved innovative drugs by the NMPA includes a diverse range of therapies, such as treatments for cancer, blood sugar regulation, and lipid management. Notably, six of these are first-in-class drugs. The regulatory body has expedited approval procedures using mechanisms like priority reviews, breakthrough therapy designations, and conditional market authorizations.
Imdelltra stands out as the sole bispecific T-cell engager antibody targeting delta-like ligand 3 and CD3 globally. Its approval marks a significant advancement in targeted immunotherapy options for solid tumors within China, introducing novel mechanisms and targets.
Analysts estimate that once launched, Imdelltra could generate around $2 billion annually for Amgen in the Chinese market.
Chinese pharmaceutical companies continue to make historic strides in developing innovative medicines. In the first quarter alone, licensing agreements for new drugs reached over $60 billion, nearly halving last year’s total, according to recent statistics from the NMPA.
Last year, over 150 licensing deals worth more than $130 billion set new records, with the NMPA approving a record 76 new drugs. Beyond licensing, the collaboration models between multinational firms and Chinese companies are evolving, moving beyond simple licensing agreements.
For example, Zai Lab and Amgen have established a collaborative model where the Chinese biotech retains full ownership of its cancer drug, Zocilurtatug, while supplying clinical trial drugs to Amgen. This approach aims to maximize the strengths of both partners to improve treatment outcomes.
The quick approval of Amgen’s small-cell lung cancer therapy by Chinese regulators is a crucial milestone, according to Zai Lab’s president. The Shanghai-based company is currently enrolling patients for a global Phase III clinical trial of Zocilurtatug, an antibody-drug conjugate targeting DLL3, which includes patients who have shown progression despite previous treatments like Tarlatamab.
Zai Lab plans to release upcoming clinical trial data on a combination therapy involving Zocilurtatug and Tarlatamab later this year, the company’s president added.
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