Amgen and BeOne Medicines get Chinese approval for small cell lung cancer drug
The authorization could help facilitate significant revenue growth
Rowan Dunne
Amgen Inc NASDAQAMGN ETRAMG and its partner BeOne Medicines AG NASDAQONC FRA49BA have secured approval in China for tarlatamab, a new treatment for small cell lung cancer.
On Apr. 10, China’s National Medical Products Administration cleared the drug for adults with extensive-stage small cell lung cancer whose tumours continued to grow after chemotherapy.
Tarlatamab essentially works by connecting a protein on cancer cells called DLL3 to immune cells, helping the body’s own defences attack and destroy the tumour. This marks the first approval of this type of therapy in China for the disease.
Headquartered in California, Amgen is one of the world’s largest biotech companies. It focuses on creating advanced medicines for cancer and other serious illnesses. BeOne Medicines, on the other hand, operates as a global oncology company with a strong presence in many countries. It specializes in blood cancer and solid tumour therapeutics.
These two firms have joined forces through a partnership in which Amgen provides the core scientific development and global expertise while BeOne leads clinical trials, regulatory submissions and commercialization activities specific to mainland China. This collaboration is helping to bring the drug to one of the world’s largest patient populations for lung cancer.
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Approval could brighten their financial outlook
The China authorization opens a huge new market as the country sees around 160,000 new small cell lung cancer cases each year.
Analysts have predicted that the drug could potentially bring in more than US$2 billion in worldwide annual sales, which would give Amgen’s oncology business a strong lift.
For BeOne, the approval strengthens its position in China and adds a high-potential product to its lineup. The achievement may help the firm grow faster in the competitive oncology space.
The news follows considerable revenue growth from both companies in 2025. BeOne reported bringing in US$5.3 billion, a 40 per cent year-over-year increase. For Amgen, annual revenue rose 10 per cent to US$36.8 billion.
Small cell lung cancer drug market expected to balloon
Multiple analysts have predicted that the global market for therapeutics targeting this aggressive respiratory disease could reach about US$23 billion by 2035. The sector is currently worth under US$10 billion.
Aside from tarlatamab, leading options include atezolizumab from Roche Holdings AG Basel ADR Common Stock OTCMKTSRHHBY and durvalumab from AstraZeneca PLC NYSEAZN FRAZEG. Patients receive these during the first round of treatment.
When the cancer returns, doctors often turn to topotecan or lurbinectedin from Jazz Pharmaceuticals PLC NASDAQJAZZ FRAJ7Z.
Tarlatamab stands apart as a first-of-its-kind bispecific antibody that directly activates the immune system against cancer cells. The China approval gives patients there a much-needed new choice in a market where effective second-line treatments have been scarce.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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