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China Drug Approvals | 2022 | NMPA Drug Approvals | Pharma | Healthcare | China | iPharmaCenter

Updated: Jun 26, 2023

Takeda announced that the National Medical Products Administration (NMPA) of China approved Exkivity (mobocertinib) for treating adults patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive non-small cell lung cancer (NSCLC). Exkivity was approved for patients who were previously treated with platinum-based chemotherapy.

Exkivity has demonstrated clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR exeon20 insertion positive NSCLC.

The approval was based on the Phase 1/2 trial, which recruited 114 patients. Patients previously treated with platinum-based chemotherapy were administered a 160 mg dose. The confirmed ORR was 28%, the median duration of response was 15.8 months, the median overall survival was 20.2 months, and the median progression-free survival was 7.3 months.

Exkivity is a tyrosine kinase inhibitor (TKI) approved in the US, UK, Switzerland, South Korea, and Australia. It was reviewed under NMPA's breakthrough Therapy program.

AstraZeneca announced that Soliris (eculizumab) would be available in China for treating adults and pediatrics with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uraemic syndrome (aHUS).

Further, the National Medicine Products Administration of China (NMPA) has accepted the supplemental application to treat adults with refractory generalized myasthenia gravis (gMG).

In September 2021, AstraZeneca set up the rare diseases unit in China. AstraZeneca announced that it was committed to bringing new therapies to China for different rare diseases, including PNH, aHUS, gMG, neuromyelitis optica spectrum disorder (NMOSD), hypophosphatasia, IgAN, LN, and amyloidosis.


AstraZeneca and Merck announced that Lynparza (olaparib), in combination with bevacizumab, was approved for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The combination is approved as a first-line maintenance treatment in patients with complete or partial response to first-line platinum-based chemotherapy.

The approval was based on Phase 3 PAOLA-1 trial, in which the combination showed substantial progression-free survival. There was a significant improvement in PFS versus bevacizumab in patients with HRD-positive advanced ovarian cancer. The PFS was 37.2 months in the Lynparza arm versus 17.7 months in patients on bevacizumab alone. The safety profile was consistent with prior trials, and no new safety issues were observed.

Merck announced a meaningful improvement in the overall survival; however, this was not statistically significant.


Beigene has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted the biological license application of tislelizumab plus chemotherapy combination as a first-line option for patients with locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

The biologics license application was supported by RATIONALE 306 interim analysis. RATIONALE 306 is Phase 3 trial comparing the efficacy of tislelizumab plus chemotherapy versus placebo plus chemotherapy. Overall survival was considered at the primary endpoint.

Tislelizumab is currently approved for nine different indications in China.


BeiGene announced that the China National Medical Products Administration (NMPA) approved the anti-PD-1 antibody, tislelizumab, for treating patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is indicated for patients whose disease progressed or are intolerant to first-line standard chemotherapy.

The approval was based on Phase 3 clinical trial, RATIONALE 302, which compared tislelizumab with chemotherapy. The overall survival (OS) was the primary endpoint. The median overall survival was 8.6 months in the tislelizumab arm versus 6.3 months in the chemotherapy arm.


Bayer announced that Vitrakvi (larotrectinib) was approved for treating Neurotrophic Tyrosine Receptor Kinase (NTRK) -fusion-positive advanced or recurrent solid tumors in China. Vitrakvi is approved for both adult and pediatric patients.

Bayer announced that Vitrakvi showed a significant response rate and durable response in clinical studies. The approval was based on

  • Phase 1 trial in adult patients

  • Phase 2 NAVIGATE trial in adults and adolescents

  • Phase 1/2 SCOUT trial in pediatrics

Bayer announced that China's National Medicinal Products Administration is evaluating the liquid formulation of Vitrakvi. Vitrakvi was previously approved in the US, Japan, Europe, and the UK.


Astellas has announced the approval of Xospata (gilteritinib) for relapsed (a disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with an FLT3 mutation by the National Medical Products Administration.

AML, the most common type of leukemia in adults, impact the blood and bone marrow. The incidence of AML in China is expected to be 80,000 people per year. The average duration of survival is less than six months in patients suffering from AML.

The product has been discovered by a collaboration with Kotobuki Pharmaceutical Co., Ltd. Astellas retains the rights to develop, manufacture, and commercialize gilteritinib. The product has already received the approvals from the drug regulatory authorities of the US and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil, and Australia in 2020.

The drug acts by inhibiting LT3- ITD, a type of FLT3mut+, a mutant that is found in one-third of patients suffering from AML.



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