Amgen announced that its bispecific T‑cell engager tarlatamab has received approval from China’s National Medical Products Administration for use as a second‑line treatment in adults with extensive‑stage small cell lung cancer whose disease has progressed after chemotherapy. The approval was disclosed by Amgen’s development and commercialization partner BeOne Medicines on WeChat on April 10 2026.
The decision to approve tarlatamab opens a significant portion of China’s oncology market, where an estimated 160,000 new cases of small cell lung cancer are diagnosed each year—about 15 % of the global burden. With the country’s oncology drug market projected to reach $69.5 billion by 2026, the approval positions Amgen to capture a share of a rapidly expanding segment that has historically lagged behind its U.S. and European markets.
Amgen’s broader strategy to diversify revenue streams and mitigate the upcoming patent cliff for mature products is reinforced by this entry. In its Q4 2025 earnings, Amgen reported a 9 % revenue increase to $9.9 billion and a 10 % full‑year growth, underscoring the company’s solid financial footing. Management highlighted the momentum in February 2026, noting that the company “enters 2026 with momentum across a broad portfolio of medicines and a clear path toward advancing innovative therapies to deliver sustained long‑term growth.”
The partnership with BeOne Medicines, which has held commercialization rights in China since 2019, is critical for navigating local regulatory pathways. China’s National Medical Products Administration has accelerated approvals for innovative drugs, and tarlatamab’s clearance likely benefited from these expedited routes. The drug is the only approved DLL3‑targeting bispecific T‑cell engager, following accelerated FDA approval in May 2024 and full FDA approval in November 2025.
Financially, analysts estimate that tarlatamab could generate over $2 billion in global sales if uptake meets expectations. While Amgen has not yet provided China‑specific revenue guidance, the company’s 2026 revenue outlook of $37 billion to $38.4 billion reflects confidence in its expanding pipeline and the potential contribution of new approvals such as this one.
The approval is expected to strengthen Amgen’s oncology portfolio and support its long‑term growth trajectory, providing a new revenue source in a high‑growth market and reinforcing the company’s strategy to broaden its global presence. Investors view the approval as a positive development that enhances Amgen’s competitive positioning in the oncology space.
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