Three Multinational Pharma Giants Accelerate China Market Layout with Concentrated Drug Approvals in a Single Week

BEIJING — Three major multinational pharmaceutical companies secured regulatory approvals for new drugs and indications in China within a single week in early November, underscoring the growing strategic importance of the Chinese market for global drugmakers.

The approvals from China's National Medical Products Administration (NMPA) span cardiovascular disease, rare diseases, and autoimmune conditions — areas where innovative therapies remain in high demand. The moves come as foreign pharmaceutical firms accelerate their push into China, where regulatory timelines have shortened and market access has improved in recent years.

The activity follows a broader pattern in 2026, when overseas drugmakers have secured a wave of new drug and indication approvals in China. These approvals have covered cardiovascular disease, rare diseases, autoimmune disorders, and oncology, with several drugs carrying "first-in-class" or "first-in-market" designations. Notably, Bayer's asundexian tablets received NMPA approval in October 2026 for reducing stroke risk in adult patients with ischemic stroke or high-risk transient ischemic attack — a China approval that came before the U.S. greenlight.

Sanofi Expands Dupixent's Reach

On Nov. 4, Sanofi announced that NMPA has approved Dupixent (dupilumab injection) for use in combination with intranasal corticosteroids to treat chronic rhinosinusitis with nasal polyps, or CRSwNP, in patients aged 12 and older whose disease is inadequately controlled by systemic corticosteroids or surgery.

Dupilumab, co-developed by Sanofi and Regeneron, is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα). The drug works by inhibiting signaling through the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which play key roles in inflammatory diseases.

The drug first received marketing approval in March 2017 for moderate-to-severe atopic dermatitis in adults whose symptoms could not be adequately controlled with topical prescription formulations. In June 2019, the FDA approved the adult CRSwNP indication, and in 2024, the agency expanded that indication to include adolescents aged 12 to 17.

Johnson & Johnson Targets Pediatric PAH

On Nov. 5, NMPA approved Johnson & Johnson's macitentan dispersible tablets for pediatric pulmonary arterial hypertension, according to the agency's website.

The approval was supported by results from TOMORROW, a Phase III, multicenter, open-label clinical trial. At week 24, macitentan demonstrated clinically meaningful improvements compared with standard of care, with statistically significant results in both children's self-reports (P=0.043) and parent reports (P=0.020).

Macitentan is an endothelin receptor antagonist. A tablet formulation was previously approved for pulmonary arterial hypertension. The newly approved dispersible tablet form offers easier swallowing and dose adjustment for pediatric patients.

Pfizer's Non-Factor Therapy Gains Foothold

On Nov. 6, Pfizer announced that NMPA has approved a new indication for marstacimab (PF-6741086), a non-factor innovative drug administered via once-weekly fixed-dose subcutaneous injection. The approval covers routine prophylactic treatment to prevent bleeding or reduce the frequency of bleeding episodes in patients aged 12 and older weighing at least 35 kilograms who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.

Marstacimab targets tissue factor pathway inhibitor (TFPI) and represents a non-factor therapy approach to hemophilia management. In 2024, the drug received approvals in the United States, European Union, and Japan, becoming the world's first anti-TFPI drug for hemophilia A or B. In China, marstacimab received its initial approval in November 2025 for routine prophylaxis in severe hemophilia A/B patients aged 12 and older.

Market Access Challenges Remain

For multinational pharmaceutical companies, China's market appeal continues to strengthen, and more overseas new drugs and indications are expected to enter the country. However, regulatory approval is just the starting point. Significant challenges remain, including hospital formulary inclusion, medical insurance coverage negotiations, and the cultivation of physician prescribing habits — hurdles that companies will need to overcome one by one to realize the full commercial potential of these approvals.