China’s National Medical Products Administration (NMPA) delivered another busy round of regulatory decisions in early September 2026, clearing a group of innovative therapies spanning oncology, infectious disease, cardiovascular medicine, hematology and rare diseases.

Among the approvals announced around September 2–3 were five notable new medicines — tasurgratinib, retavibart, clulevibart, etripamil and rilzabrutinib — alongside important new indications for ensartinib and luvometinib.

The wave is particularly notable for the simultaneous arrival of two domestically developed long-acting antibodies for respiratory syncytial virus (RSV), as well as new treatment options in FGFR2-driven biliary tract cancer, paroxysmal supraventricular tachycardia (PSVT), immune thrombocytopenia (ITP), ALK-positive lung cancer and neurofibromatosis type 1 (NF1). (CNPharm)

1. Tasurgratinib — New FGFR-Targeted Option for Biliary Tract Cancer

The NMPA approved tasurgratinib succinate, an oral selective FGFR tyrosine kinase inhibitor, for patients with unresectable biliary tract cancer harboring FGFR2 gene fusions or rearrangements whose disease has progressed following prior chemotherapy. (PharmAdj)

Tasurgratinib, originally developed by Eisai, selectively inhibits FGFR1, FGFR2 and FGFR3. The drug was previously approved in Japan for a similar FGFR2-altered biliary tract cancer population and launched there in November 2024. (Eisai)

In February 2025, SciClone Pharmaceuticals entered into a licensing agreement with Eisai, obtaining exclusive rights to develop and commercialize tasurgratinib in Greater China, including Mainland China, Hong Kong, Macau and Taiwan. Eisai retained rights elsewhere and continues to manufacture the product. (Eisai)

The approval adds another precision medicine option for Chinese patients with FGFR2-driven biliary tract malignancies, particularly intrahepatic cholangiocarcinoma.

2. Retavibart (TNM001) — Long-Acting RSV Antibody for Infants

The NMPA also approved retavibart injection, formerly known as TNM001, developed by Trinomab Biopharmaceuticals.

Retavibart is a long-acting recombinant human monoclonal antibody targeting the RSV fusion protein and is approved for newborns and infants who are entering or born during their first RSV season, for prevention of RSV-associated lower respiratory tract infection. The drug went through China’s priority-review pathway. (CN Stock)

Trinomab’s NDA for TNM001 was accepted by the NMPA in February 2026 and granted priority review in March. The company describes retavibart as a domestically developed long-acting RSV preventive antibody. (Trinomab)

Its approval represents an important step toward expanding locally developed RSV prophylaxis options for Chinese infants.

3. Clulevibart (RB0026) — A Second Homegrown Long-Acting RSV Antibody

In a striking same-day development, the NMPA also approved clulevibart injection, formerly RB0026, developed by Reyoung (Shandong) Biopharmaceutical.

Clulevibart is another long-acting monoclonal antibody directed against the RSV F protein. It is approved to prevent RSV-associated lower respiratory tract infection in newborns and infants born at ≥35 weeks of gestational age who are entering or born during their first RSV season.

The approved population excludes children with chronic lung disease, including bronchopulmonary dysplasia, as well as those with clinically significant congenital airway abnormalities. The application was reviewed through the NMPA’s priority-review pathway. (CNPharm)

Shortly before the approval, Simcere Pharmaceutical entered a strategic partnership with Reyoung Bio under which Simcere obtained exclusive commercialization rights for clulevibart in Greater China. (Simcere)

The near-simultaneous approval of clulevibart and retavibart creates an unusual situation in which two domestically developed long-acting RSV antibodies are entering China’s infant RSV-prevention market at essentially the same time. (Yicai Global)

4. Etripamil Nasal Spray — At-Home Rescue Option for PSVT

The NMPA approved etripamil nasal spray for converting acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

Developed by Milestone Pharmaceuticals and licensed to Everest Medicines for Greater China, etripamil is a rapidly acting, self-administered nasal therapy intended to give patients a potential treatment option outside the traditional emergency-care setting. (GlobeNewswire)

The Chinese approval was supported by the global Phase 3 RAPID trial and the China Phase 3 JX02002 study. In JX02002, etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes, with a hazard ratio of 3.002 (95% CI: 1.578–5.711; p=0.0005). (GlobeNewswire)

The approval is also significant commercially: it represents etripamil’s first regulatory approval outside the United States and triggered a $2 million milestone payment from Everest to Milestone. Milestone remains eligible for up to $98 million in additional development and commercial milestones plus tiered royalties of up to 18% on Greater China sales. (GlobeNewswire)

5. Rilzabrutinib — BTK Inhibition Moves Further Into Autoimmune Disease

The NMPA also approved rilzabrutinib, Sanofi’s oral reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for adults with persistent or chronic primary immune thrombocytopenia (ITP) who have had an inadequate response or intolerance to previous treatments such as corticosteroids or intravenous immunoglobulin. (CLS Finance)

Rilzabrutinib represents a different approach to BTK inhibition from the oncology-focused BTK inhibitors that established the drug class. Rather than primarily targeting malignant B cells, rilzabrutinib is being developed as a multi-immune modulator for antibody-mediated and inflammatory diseases.

The drug’s global development program includes the pivotal Phase 3 LUNA 3 study in ITP. It has already received regulatory approvals for ITP in other major markets, including Japan. (Sanofi)

For Sanofi, the China approval further strengthens rilzabrutinib’s position as an important component of its immunology and rare-disease portfolio.

Two Important New-Indication Approvals

Beyond the new medicines, the NMPA also expanded the labels of two Chinese-developed targeted therapies — ensartinib and luvometinib.

6. Ensartinib Expands Into Adjuvant ALK-Positive NSCLC

Ensartinib, developed by Betta Pharmaceuticals, received approval for a new indication as postoperative adjuvant therapy for ALK-positive non-small cell lung cancer (NSCLC).

More specifically, the newly approved indication covers patients with stage IB–IIIB ALK-positive NSCLC following surgical resection, with the physician determining whether the patient receives adjuvant chemotherapy. (Betta Pharmaceuticals)

The approval was supported by the randomized, double-blind ELEVATE registration study involving 56 medical centers in China. (Betta Pharmaceuticals)

The decision represents ensartinib’s third approved indication in China, extending the drug from treatment of advanced ALK-positive NSCLC into earlier-stage disease and potentially increasing the number of patients who can benefit from ALK-targeted therapy.

7. Luvometinib Expands NF1-PN Treatment to Adults

Finally, Fosun Pharma announced that the NMPA approved a new indication for its internally developed MEK1/2 inhibitor luvometinib for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). (Fosun Pharma)

The approval follows the drug’s previous authorization in patients aged 2 years and older, meaning luvometinib can now address NF1-PN across pediatric, adolescent and adult populations in China. (Fosun Pharma)

NF1 is a genetic disorder driven by pathogenic alterations in the NF1 gene. Plexiform neurofibromas occur in a substantial proportion of patients and can cause pain, disfigurement, neurological impairment and organ dysfunction. Surgery has historically been an important treatment option, but complete resection can be difficult or impossible depending on tumor location.

By inhibiting MEK1/2 downstream of the dysregulated RAS/MAPK pathway, luvometinib provides a targeted pharmacologic strategy for patients with inoperable disease.

A Broad Regulatory Wave Across Multiple Therapeutic Areas

Taken together, the early-September approvals illustrate the increasing breadth of China’s innovative-drug market.

Drug	Company/Partner	Modality/Target	Approved indication
Tasurgratinib	SciClone / Eisai	FGFR1/2/3 TKI	FGFR2 fusion/rearrangement-positive unresectable biliary tract cancer after chemotherapy
Retavibart (TNM001)	Trinomab	Long-acting RSV antibody	Prevention of RSV LRTI in newborns/infants entering their first RSV season
Clulevibart (RB0026)	Reyoung Bio / Simcere	Long-acting RSV antibody	RSV LRTI prevention in eligible ≥35-week newborns/infants
Etripamil	Everest / Milestone	Nasal calcium-channel blocker	Acute symptomatic PSVT in adults
Rilzabrutinib	Sanofi	Reversible covalent BTK inhibitor	Persistent/chronic primary ITP in previously treated adults
Ensartinib	Betta Pharma	ALK TKI	Adjuvant treatment of resected ALK-positive NSCLC
Luvometinib	Fosun Pharma	MEK1/2 inhibitor	Adult NF1 with symptomatic, inoperable PN

The approvals are notable not simply for their number but also for their diversity. Two locally developed RSV antibodies are arriving almost simultaneously, Chinese-developed targeted therapies are moving into earlier-stage cancer and broader age groups, and globally developed drugs such as etripamil, rilzabrutinib and tasurgratinib are reaching China through licensing and multinational development strategies.

Together, the seven regulatory decisions provide another snapshot of a Chinese pharmaceutical market increasingly characterized by domestic innovation, global licensing partnerships and rapid expansion of precision and specialty medicines.

References

1. China Food and Drug Network / NMPA – “Five innovative drugs approved in succession,” September 3, 2026. Covers the NMPA approvals of retavibart, clulevibart, etripamil and rilzabrutinib. Read the report
2. SciClone Pharmaceuticals – Tasurgratinib approved in China. Tasurgratinib received NMPA approval for FGFR2 fusion/rearrangement-positive unresectable biliary tract cancer following chemotherapy. Approval report
3. Eisai – Greater China licensing agreement with SciClone, February 28, 2025. Details SciClone’s exclusive Greater China rights to tasurgratinib. Eisai licensing announcement
4. Trinomab – Retavibart development and regulatory history. The TNM001 NDA was accepted in February 2026 and subsequently granted priority review. Trinomab announcement
5. Simcere – Strategic partnership with Reyoung Bio, August 2026. Simcere obtained exclusive Greater China commercialization rights to clulevibart. Simcere announcement
6. Milestone Pharmaceuticals – NMPA approval of etripamil nasal spray, September 3, 2026. Includes the China indication, clinical data and Everest licensing arrangement. Milestone announcement
7. Everest Medicines – CARDAMYST approval in China. Everest will commercialize etripamil in Greater China. Everest announcement
8. NMPA report – Rilzabrutinib approval. The drug was approved for previously treated persistent or chronic primary ITP in adults. NMPA-sourced report
9. Betta Pharmaceuticals – Ensartinib postoperative adjuvant indication approved, September 3, 2026. Includes details of the ELEVATE registration study. Betta Pharma announcement
10. Fosun Pharma – Luvometinib adult NF1 indication approved, September 3, 2026. The approval extends NF1-PN treatment coverage to adult patients. Fosun Pharma announcement