Johnson & Johnson, Innovent and Others Secure Multiple New Drug and Indication Approvals in China This Week

　　【Pharmaceutical Network Product InformationIn recent years, against the backdrop of strong regulatory support for innovation and improved efficiency in review and approval processes, China's pharmaceutical industry has ushered in a period of intensive new drug launches. By the end of 2025, another wave of approvals is anticipated. Between December 22 and 26, the National Medical Products Administration (NMPA) has already approved new drugs and new indications from a large number of pharmaceutical companies including Johnson & Johnson, Innovent Bio, and Daiichi-Sankyo.
 

For example, on December 26, Johnson & Johnson announced that its innovative therapeutic drug Rikokib® — Amivantamab Injection (Subcutaneous Injection) was approved by the National Medical Products Administration for the treatment of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) mutations.
 

Amivantamab is a fully human EGFR×MET bispecific antibody that offers patients greater convenience and reduces administration time from several hours to approximately 5 minutes. Additionally, compared to intravenous formulations, the incidence of infusion-related adverse reactions is reduced by 80%.
 

On December 25, Innovent Bio's self-developed anti-CTLA-4 monoclonal antibody, Tyvyt® (Ipilimumab N01 Injection), received approval from the National Medical Products Administration (NMPA) for use in combination with the PD-1 inhibitor, Tyvyt® (Sintilimab Injection), as neoadjuvant therapy for patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer.
 

Tyvyt® (达伯舒®) in combination with Daboshin® (达伯欣®) has been approved for multiple indications in China and is widely used in high-incidence cancer types such as lung cancer, liver cancer, and esophageal cancer. This dual immunotherapy combination with Daboshin® marks the ninth approved indication for Tyvyt® in China. Notably, with the approval of Daboshin®, Innovent Bio has successfully launched seven innovative drugs in 2025, covering four key disease areas: oncology, metabolism, autoimmune diseases, and ophthalmology.
 

Daiichi Sankyo announced on December 25 that another new indication for its HER2 ADC drug, trastuzumab deruxtecan, co-developed with AstraZeneca, has been approved for marketing in China. The drug is indicated for adult patients with HR-positive, HER2-low, or HER2-ultra-low breast cancer. This medication is a DXd ADC targeting HER2, designed using Daiichi Sankyo's proprietary technology. It is reported that in March 2019, Daiichi Sankyo and AstraZeneca entered into a $6.9 billion collaboration to jointly develop and commercialize this product globally.
 

On December 23, Zai Lab announced that the China National Medical Products Administration had approved the new drug application for KarXT (brand name: Kaili®) capsules for the treatment of adult schizophrenia. In November 2021, Zai Lab acquired the exclusive rights to develop, manufacture, and commercialize KarXT in Greater China from Karuna Therapeutics for $187 million. This approval was based on data from a Phase I pharmacokinetic study conducted in China, a Phase III clinical trial in China (ZL-2701-001), and three global EMERGENT clinical trials.
 

On December 22, AstraZeneca's Fantruximab Injection (Benralizumab Injection) received approval from the China National Medical Products Administration for a new indication to treat adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). Novo Nordisk’s Semaglutide Injection (brand name: NovoGain®) also obtained approval for its cardiovascular indication, aimed at reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adult patients with confirmed cardiovascular disease and BMI ≥27kg/m². Additionally, Beijiamai (Pimitespib Hydrochloride Capsules), developed by Abbisko Therapeutics and commercialized by Merck, was also announced on the same day to have been approved via the priority review process for use in adult patients with symptomatic Tenosynovial Giant Cell Tumor (TGCT) where surgical resection may lead to functional limitations or severe complications.
 

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