Henlius' H Drug Rapidly Enters Indian Market, Advancing Global Expansion

On July 31, Henlius (2696.HK) announced that the first batch of its self-developed anti-PD-1 monoclonal antibody H drug (brand name: Hansizhuang®, generic name: serplulimab) has been shipped to the Indian market. This marks the official launch of the world's first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in the world's most populous country—achieved in just over 30 days after receiving approval from India's Central Drugs Standard Control Organization (CDSCO) in late June. To date, Hansizhuang® has been approved in nearly 40 countries and regions, covering nearly half of the global population and benefiting over 110,000 patients.

Lightning-Fast Market Entry in India

H drug was approved by India's CDSCO in late June 2025 for first-line ES-SCLC treatment, making it the first and only anti-PD-1 monoclonal antibody approved for this indication in India. Its swift transition from approval to market entry demonstrates remarkable speed in market access.

India faces severe challenges in lung cancer prevention and treatment. Data shows that in 2022, India reported over 81,000 new lung cancer cases and more than 75,000 deaths, with lung cancer ranking among the top in both incidence and mortality rates. The approval and commercialization of H drug address long-standing unmet clinical needs in ES-SCLC treatment, offering local patients an innovative first-line immunotherapy option.

As the world's first anti-PD-1 monoclonal antibody approved for first-line ES-SCLC treatment, H drug has gained approvals in nearly 40 countries and regions since its launch, covering nearly half of the global population and benefiting over 110,000 patients. Its entry into the Indian market represents a critical step in its global strategy.

To accelerate H drug's growth in India, Henlius has partnered with Intas, a leading local pharmaceutical company, to handle commercialization. Intas' deep local market insights and extensive distribution network will facilitate rapid market access and coverage for H drug.

Cao Ping, Chief Business Development Officer and Senior Vice President of Henlius, stated that the swift supply of H drug post-approval reflects the efficient collaboration between Henlius and Intas. Leveraging H drug's differentiated advantages and Intas' local commercialization expertise, the partnership aims to provide high-quality, affordable innovative therapies to more patients, improving treatment accessibility.