Henlius HANDAYUAN Received DRAP Approval In Pakistan

• Henlius’ 8th self-developed product breaking into global market
• HANDAYUAN's first approval beyond China to benefit patients in emerging markets

Shanghai Henlius Biotech, Inc. announced that the company’s business partner Getz Pharma (Private) Limited (Getz Pharma) has received the relevant registration certificates from the Drug Regulatory Authority of Pakistan (DRAP) for the approval of Henlius’ self-developed and manufactured adalimumab biosimilar HANDAYUAN under the trade name Adaliget, covering all indications of the reference biological product approved in Pakistan. HANDAYUAN is Henlius' eighth product approved for ex-China marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), Poherdy (pertuzumab), and HANBEITAI (bevacizumab).

According to the Global Burden of Disease (GBD) 2023 study, the total number of patients with rheumatoid arthritis and psoriasis in 2023 is over fifty million and the number continues to grow.1 Adalimumab is one of the world's best-selling drugs. It has been approved for over 10 autoimmune indications worldwide, including rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis (Ps) and uveitis (UV), and it has been recommended by clinical practice guidelines for different autoimmune diseases in North America and Europe. In many emerging markets, however, market penetration of adalimumab has yet to increase.

Based on the licensing and supply agreement between the two companies in 2022, Getz Pharma is committed to bringing Adaliget to 11 emerging markets in Asia, Africa and Europe, including Pakistan, and this approval will help both parties bring HANDAYUAN to more local patients.

HANDAYUAN is Henlius’ first self-developed monoclonal antibody in autoimmune treatment and was approved by the NMPA in December 2020. Fosun Wanbang is responsible for the commercial sales of HANDAYUAN in China. In July 2026, it was included in the China’s National Essential Medicines List (2026 Edition).

The approval of HANDAYUAN by DRAP of Pakistan is mainly based on the review of a series of studies. The relevant application materials are mainly based on the information in the New Drug Application (NDA) in relation to the product submitted to China’s National Medical Products Administration (NMPA). Henlius has taken multiple head-to-head comparisons between HANDAYUAN and the reference adalimumab, including analytical studies, non-clinical studies and clinical studies. The results showed that HANDAYUAN and reference adalimumab are highly similar in terms of quality, safety and efficacy.

The development, manufacturing facility for HANDAYUAN and the quality management system are in line with global standards. HANDAYUAN is the first adalimumab biosimilar evaluated in a Phase 3 clinical study among Chinese patients with Ps. Henlius’ manufacturing facilities along with their quality management systems, have successfully passed approximately 100 on-site inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners.

In addition to Adaliget, Henlius and Getz Pharma expanded their collaboration in December 2024, granting Getz Pharma exclusive commercialization rights to HANQUYOU (trastuzumab) in Pakistan. Going forward, Henlius will continue to uphold international quality standards and work with partners including Getz Pharma to advance the approval and launch of more biologics worldwide, bringing more treatment options to patients across different markets.

About Getz Pharma
Getz Pharma (Private) Limited was established in the Islamic Republic of Pakistan in 1995, which mainly specializes in the formulation development, manufacturing and marketing of a wide range of pharmaceutical products. It currently operates in more than 45 countries in South Asia, Central Asia, South East Asia, the Middle East and Africa and has more than 8,000 employees worldwide.