China Innovative Oncology Drugs: 15 New Approvals in H1 2026

According to publicly available information, 38 innovative drugs were approved for marketing in China in the first half of 2026, including 31 domestically developed innovative drugs. Among them, 15 innovative drugs were approved in the oncology field.

These products cover multiple disease areas, including gastric cancer, lung cancer, myelofibrosis, thyroid cancer, lymphoma, breast cancer, and nasopharyngeal cancer.

As a China pharmaceutical wholesaler, DengYueMed provides an overview of the 15 China innovative oncology drugs approved during the first half of 2026, listed in chronological order of their approval dates.

1. Retlirafusp Alfa Injection

Approval date: January 7, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Retlirafusp alfa injection was approved in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of patients with PD-L1-positive (CPS ≥1), locally advanced unresectable, recurrent, or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

It is the first approved PD-L1/TGF-βRII bispecific antibody fusion protein globally and is a Class 1 innovative drug independently developed by Hengrui Pharmaceuticals.

2. Human Thyrotropin Beta for Injection

Approval date: January 8, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Human thyrotropin beta for injection is used for follow-up assessment in patients with differentiated thyroid cancer after total or near-total thyroidectomy. It can be used in conjunction with serum thyroglobulin (Tg) testing and, when clinically appropriate, with radioactive iodine (¹³¹I) whole-body scanning.

It is the first innovative product approved in China for the postoperative assessment of differentiated thyroid cancer, providing a new complementary diagnostic option for relevant patients.

3. Rovadicitinib

Approval date: February 28, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Rovadicitinib is indicated as a first-line treatment for adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).

Myelofibrosis is a myeloproliferative neoplasm. The approval of rovadicitinib further expands treatment options for myelofibrosis in China.

4. Sosimerasib

Approval date: February 28, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Sosimerasib is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have previously received at least one systemic therapy.

KRAS G12C has become an important molecular target in precision lung cancer treatment. Targeted therapies against KRAS G12C further reflect the evolution of NSCLC treatment from traditional histological classification toward molecular profiling and precision targeted therapy.

5. 99mTc-3PRGD2

Approval date: April 2, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

99mTc-3PRGD2 injection and the corresponding kit for injection were approved for marketing as an adjunctive diagnostic tool for assessing regional lymph node metastasis in patients with suspected lung cancer.

The product is a Class 1 innovative radiopharmaceutical developed by a Chinese pharmaceutical company and represents an innovative nuclear medicine diagnostic product. It is also described as the first broad-spectrum tumor imaging agent approved for SPECT imaging.

6. Sevabertinib

Approval date: April 15, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Sevabertinib is indicated for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 activating mutations who have previously received at least one systemic therapy.

It is an oral small-molecule tyrosine kinase inhibitor (TKI) that further expands precision treatment options for patients with HER2-mutant NSCLC.

7. Bezacitinib

Approval date: April 30, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Bezacitinib is indicated as a first-line treatment for adult patients with intermediate-2 or high-risk myelofibrosis (MF), including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.

The approval further expands treatment options for first-line therapy of myelofibrosis.

8. Andamertinib

Approval date: April 30, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Andamertinib is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion (EGFR ex20ins) mutations who have progressed during or after platinum-containing chemotherapy or are intolerant to platinum-containing chemotherapy.

Andamertinib is a novel small-molecule irreversible tyrosine kinase inhibitor independently developed by Avistone Biotechnology, with high selectivity and the ability to cross the blood-brain barrier.

9. Anbenitamab

Approval date: May 28, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Anbenitamab, in combination with chemotherapy, is indicated for the treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one HER2-containing treatment regimen.

Anbenitamab is the first HER2 bispecific antibody developed in China to receive marketing approval, making it a notable example of China innovative oncology drugs entering the clinical oncology landscape.

10. Eratrectinib

Approval date: June 4, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Eratrectinib is indicated for adults and adolescents aged 12 years and older with solid tumors who meet the following conditions:

• Harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion;
• Have locally advanced or metastatic disease, or disease in which surgical resection is likely to result in severe complications, and have no satisfactory alternative treatment or have failed previous treatment.

11. Rocbrutinib

Approval date: June 4, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Rocbrutinib is indicated for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies, including treatment with a BTK inhibitor.

Rocbrutinib is a fourth-generation BTK inhibitor with both covalent and non-covalent mechanisms of action. It was developed by Lupeng Pharmaceutical using its proprietary BeyondX oral drug chemistry platform.

12. Conteltinib

Approval date: June 11, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Conteltinib is indicated for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

ALK-positive NSCLC is an important molecular subtype in precision lung cancer treatment. As ALK-targeted therapies continue to evolve, treatment strategies for ALK-positive lung cancer are also undergoing continuous development.

13. Satricabtagene Autoleucel

Approval date: June 22, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Satricabtagene autoleucel injection was approved through the priority review and approval procedure for the treatment of patients with CLDN18.2-positive, HER2-negative advanced gastric cancer or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of treatment.

This CAR-T therapy, independently developed by CARsgen Therapeutics, is the first approved CAR-T cell therapy for a solid tumor globally, representing a major breakthrough in cell therapy and one of the notable China innovative oncology drugs in recent years.

14. Izalontamab Brengitecan

Approval date: June 22, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

Izalontamab brengitecan is indicated for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and treatment with a PD-1/PD-L1 inhibitor.

Izalontamab brengitecan is a first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC) and the first of its kind to receive marketing approval globally. Its approval highlights the growing innovation of China innovative oncology drugs in next-generation cancer therapies.

15. Imlunestrant

Approval date: June 22, 2026

Approval authority: National Medical Products Administration (NMPA)

Main indication:

• Imlunestrant as monotherapy is indicated for adults with locally advanced or metastatic breast cancer that is estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and estrogen receptor 1 (ESR1) mutation-positive, who have previously received endocrine therapy;
• In combination with abemaciclib, imlunestrant is indicated for the same patient population with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following prior endocrine therapy.

Quick Overview of China Innovative Oncology Drugs Approved in H1 2026

Approval Date	Drug	Main Therapeutic Area	Key Target / Direction
January 7	Retlirafusp alfa injection	Gastric cancer	PD-L1
January 8	Human thyrotropin beta	Postoperative thyroid cancer assessment	Cancer diagnosis
February 28	Rovadicitinib	Myelofibrosis	MF
February 28	Sosimerasib	Non-small cell lung cancer	KRAS G12C
April 2	99mTc-3PRGD2	Lung cancer adjunctive diagnosis	Nuclear medicine imaging
April 15	Sevabertinib	Non-small cell lung cancer	HER2 mutation
April 30	Bezacitinib	Myelofibrosis	MF
April 30	Andamertinib	Non-small cell lung cancer	EGFR ex20ins
May 28	Anbenitamab	Gastric cancer	HER2
June 4	Eratrectinib	Solid tumors	NTRK fusion
June 4	Rocbrutinib	Mantle cell lymphoma	MCL
June 11	Conteltinib	Non-small cell lung cancer	ALK
June 22	Satricabtagene autoleucel	Gastric cancer	CLDN18.2
June 22	Izalontamab brengitecan	Nasopharyngeal cancer	Recurrent/metastatic NPC
June 22	Imlunestrant	Breast cancer	ESR1

Conclusion

In the first half of 2026, 15 China innovative oncology drugs were approved for marketing, covering multiple cancer types, molecular targets, and therapeutic technology platforms.

From KRAS G12C, EGFR ex20ins, ALK, and NTRK targets to CLDN18.2-directed cell therapy and nuclear medicine diagnostics, these approvals highlight the continued innovation of oncology drugs in China.

For the global pharmaceutical industry, China’s oncology drug market is becoming an increasingly important market to watch for innovation and potential collaboration.

DengYueMed, a Hong Kong-based pharmaceutical wholesaler, focuses on Chinese innovative medicines and oncology drugs, helping global pharmaceutical partners understand the China innovative oncology drugs market and access reliable supply channels from China.

FAQ about China Innovative Oncology Drugs