China Drug Approvals — April 2026
China Drug
Approvals — April 2026
China’s NMPA approved 3 drugs in April 2026: Bewintinib (JAK2 inhibitor for three myelofibrosis indications), Andamertinib (EGFR exon 20 insertion inhibitor for NSCLC), and CanSino Biologics’ adsorbed DTP combination vaccine.
3 drugs approved in China — April 2026
All data from the April 2026 monthly report, Table 1.
| Drug | Target | Modality | Indication | Developer | Date |
|---|---|---|---|---|---|
| Bewintinib | JAK2 | Small molecule drug | Post-PV myelofibrosis; Post-ET myelofibrosis; Primary Myelofibrosis | Hangzhou Bangshun Pharmaceutical | Apr 29 |
| Andamertinib | EGFR | Small molecule drug | EGFR exon 20 insertion mutation NSCLC | Avistone (Ningbo) Biotechnology | Apr 29 |
| Adsorbed DTP Combination Vaccine (CanSino) | — | Combination vaccine; Prophylactic vaccine | Diphtheria; Tetanus; Whooping Cough | CanSino Biologics, Inc. | Apr 7 |
Both oncology approvals profiled
Bewintinib — JAK2 inhibitor for three myelofibrosis indications
Bewintinib is a small molecule drug targeting JAK2, developed by Hangzhou Bangshun Pharmaceutical Co., Ltd. It was approved by China’s NMPA on April 29, 2026 for Post-polycythemia vera myelofibrosis, Post-essential thrombocythemia myelofibrosis, and Primary Myelofibrosis. JAK2 (Janus kinase 2) drives constitutive signalling in myeloproliferative neoplasms — a drug class well established by ruxolitinib and fedratinib in Western markets, here extended with a domestically developed Chinese programme.
JAK2 · Small molecule · Myelofibrosis · 3 indicationsAndamertinib — EGFR exon 20 insertion inhibitor for NSCLC
Andamertinib is a small molecule drug targeting EGFR, developed by Avistone (Ningbo) Biotechnology Co., Ltd. It was approved by China’s NMPA on April 29, 2026 for EGFR exon 20 insertion (ex20ins) mutation non-small cell lung cancer — a specific EGFR mutation subtype historically resistant to first-, second-, and third-generation EGFR inhibitors. Andamertinib also received a Conditional Marketing Approval for the same indication from NMPA on April 30, 2026.
EGFR ex20ins · Small molecule · NSCLC · Avistone3 signals from China’s April 2026 approval data
Andamertinib: domestic EGFR ex20ins approval joins amivantamab in a targeted subtype
Andamertinib’s NMPA approval for EGFR exon 20 insertion NSCLC reflects the growing depth of China’s domestic EGFR inhibitor pipeline targeting mutation-specific subtypes. EGFR ex20ins mutations account for approximately 2–3% of NSCLC cases and are largely resistant to standard EGFR TKIs — a well-defined unmet need that has attracted multiple development programmes globally. Andamertinib also received CMA from NMPA on April 30, reflecting expedited regulatory engagement for this high-unmet-need subtype.
Bewintinib: domestic JAK2 inhibitor approval expands China’s myelofibrosis treatment options
Bewintinib’s NMPA approval across three myelofibrosis indications — primary, post-PV, and post-ET — mirrors the indication scope of ruxolitinib (Jakafi), the established JAK1/JAK2 inhibitor standard-of-care in this disease. Developed by Hangzhou Bangshun Pharmaceutical Co., Ltd., Bewintinib is a domestically developed Chinese JAK2 inhibitor, extending access to targeted myelofibrosis therapy for Chinese patients and creating domestic competition to imported JAK inhibitors in this indication space.
CanSino DTP vaccine: paediatric vaccine pipeline diversification beyond COVID-19
CanSino Biologics’ NMPA approval for an adsorbed DTP (Diphtheria-Tetanus-Pertussis) combination vaccine on April 7, 2026 reflects the company’s diversification into established paediatric vaccine categories beyond its COVID-19 vaccine programmes. DTP combination vaccines are a foundational component of national immunisation programmes; domestic Chinese approval positions CanSino as a multi-disease vaccine platform company, extending the commercial base of its vaccine manufacturing and distribution infrastructure.
Both April 2026 oncology approvals are domestic Chinese small molecules
Both April 2026 oncology approvals from China’s NMPA — Bewintinib (Hangzhou Bangshun, JAK2) and Andamertinib (Avistone Ningbo, EGFR ex20ins) — are domestically developed small molecule drugs. This pattern reflects the maturation of China’s innovative pharmaceutical sector, which increasingly delivers first-in-class or best-in-class small molecule programmes from domestic developers across oncology target classes — extending well beyond the earlier licensing-and-localisation model.
China drug approvals April 2026 — key questions
China’s NMPA approved 3 drugs in April 2026: Bewintinib (JAK2 inhibitor, myelofibrosis), Andamertinib (EGFR inhibitor, EGFR exon 20 insertion mutation NSCLC), and an adsorbed DTP combination vaccine from CanSino Biologics.
Bewintinib is a small molecule drug targeting JAK2, developed by Hangzhou Bangshun Pharmaceutical Co., Ltd. It was approved by China’s NMPA on April 29, 2026 for Post-polycythemia vera myelofibrosis, Post-essential thrombocythemia myelofibrosis, and Primary Myelofibrosis.
Andamertinib is a small molecule drug targeting EGFR, developed by Avistone (Ningbo) Biotechnology Co., Ltd. It was approved by China’s NMPA on April 29, 2026 for EGFR exon 20 insertion mutation non-small cell lung cancer.
An Adsorbed DTP Combination Vaccine developed by CanSino Biologics, Inc. was approved by China’s NMPA on April 7, 2026 for Diphtheria, Tetanus, and Whooping Cough (Pertussis).
Bewintinib was developed by Hangzhou Bangshun Pharmaceutical Co., Ltd. and received NMPA approval in China on April 29, 2026 for myelofibrosis indications.
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report, Table 1 (drug approvals). Represents a snapshot of available records as of April 2026.