New Wave of Anti-Cancer Drugs and Indications Approved in China, Offering Fresh Hope for Patients

　　【Pharmaceutical Network Product Information] The number of cancer patients in China is enormous. With the intensification of population aging, the number of new cancer cases in China continues to increase, driving the continuous growth of the anti-cancer drug market. Data shows that the scale of China's anti-cancer drug market reached 326 billion yuan in 2023. As advancements in cancer treatment methods accelerate, the future market holds immense potential.
 

Targeting a market space worth hundreds of billions, pharmaceutical companies in and outside of China are increasing their investments. Since 2025, there have been continuous positive updates on newly approved drugs and indications, which will offer more treatment options to patients.
 

　　HUTCHMED: New Indication for Lung Cancer Drug Approved
 

On January 13, the website of China's National Medical Products Administration (NMPA) announced that the new indication application for Savolitinib tablets from HUTCHMED has been approved. Savolitinib is a highly selective oral MET inhibitor. According to previous information provided by HUTCHMED, this approval is for treating adult patients with locally advanced or metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations.
 

This approval also means that the new label indication for savolitinib in China has been expanded to cover previously untreated patients. Public information shows that savolitinib had already received conditional approval in China for the treatment of patients with MET exon 14 skipping mutations in non-small cell lung cancer whose disease has progressed after systemic therapy or who are unable to receive chemotherapy.
 

Notably, in 2011, HUTCHMED entered into a global licensing agreement with AstraZeneca to co-develop savolitinib and promote its commercialization. HUTCHMED and AstraZeneca are collaborating on the clinical development of savolitinib, with HUTCHMED taking the lead in China and AstraZeneca leading internationally. Additionally, HUTCHMED is responsible for the marketing authorization, production, and supply of savolitinib in China, while AstraZeneca is responsible for the commercialization of savolitinib in China and globally.
 

　Johnson & Johnson: New Cancer Drug Approved for Marketing in China
 

Recently, Johnson & Johnson, a multinational pharmaceutical company, announced that the marketing application for Erdafitinib tablets has been officially approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with surgically unresectable locally advanced or metastatic urothelial carcinoma (UC) who carry susceptible FGFR3 gene alterations and have experienced disease progression during or after at least one prior line of therapy containing anti-PD-1 or anti-PD-L1.
 

Urothelial carcinoma is the most common type of bladder cancer. Some patients with metastatic urothelial carcinoma carry FGFR gene mutations, and the prognosis for these patients is generally poor, with a very low five-year survival rate for those with advanced metastasis.
 

Public information shows that erdafitinib is a pan-FGFR inhibitor, which can significantly improve the overall survival and progression-free survival of patients with FGFR3 gene mutations, providing a new treatment option for patients with limited prior treatment choices.
 

Notably, the guidelines released by the European Society for Medical Oncology in 2024 and the European Association of Urology in 2024 both specifically highlight that patients diagnosed with advanced bladder cancer should undergo molecular/genetic testing as soon as possible to facilitate more precise treatment decisions, avoid delays in diagnosis, and prevent any impact on subsequent treatments.
 

　　Sanofi: Innovative Hematological Oncology Drug Approved for Marketing
 

On January 9, Sanofi announced that its anti-CD38 monoclonal antibody Sarclisa (isatuximab injection) had been approved by the National Medical Products Administration (NMPA) for use in combination with pomalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy (including lenalidomide and proteasome inhibitors).
 

Data show that multiple myeloma is a common malignant hematological tumor, frequently occurring in the elderly population. This type of disease is an incurable cancer, and patients often face the dual challenges of recurrence and drug resistance after recurrence.
 

Isatuximab Injection Receives Approval, Providing a Key Pillar for Innovative Treatment of First Relapse in Multiple Myeloma Patients and Promoting Earlier Survival Benefits.
 

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