The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, the supplemental applications of HANDAYUAN (adalimumab injection) which is independently developed by the Company for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn's disease and pediatric Crohn' s disease have been approved by the National Medical Products Administration. Common Name: Adalimumab injection. Trade Name: HANDAYUAN.

Dosage Form: Injection. Specification: 40 mg (0.8 ml)/vial. Registration Category: Biological Product for Treatment Purpose Drug Manufacturer: Shanghai Henlius Biopharmaceutical Co.

Ltd. Review Conclusions: According to the Drug Administration Law of the People's Republic of China and relevant requirements, upon review, the drug satisfied the relevant requirements for drug registration and the supplemental new drug applications of inclusion of four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn's disease and pediatric Crohn's disease are approved. HANDAYUAN (adalimumab injection) is a biosimilar of adalimumab independently developed by the Company, was approved by the NMPA in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below) in December 2020. As of the date of this announcement, HANDAYUAN has been approved for eight indications in mainland China: (1) rheumatoid arthritis; (2) ankylosing spondylitis; (3) plaque psoriasis; (4) uveitis; (5) polyarticular juvenile idiopathic arthritis; (6) pediatric plaque psoriasis; (7) Crohn' s disease; and (8) pediatric Crohn's disease.

As at the date of this announcement, in addition to the Company's HANDAYUAN, the adalimumab marketed in mainland China include Humira® of AbbVie, Anjianning of Hisun Biopharmaceutical Co. Ltd. and QLETLI of Bio-Thera Solutions Ltd., etc. The adalimumab marketed globally include Humira ® of AbbVie, Amgevita ® of Amgen and Hyrimoz of Sandoz, etc.

According to the information of IQVIA CHPA and IQVIA MIDASTM (IQVIA is a global provider of professional information and strategic consulting services in the pharmaceutical and healthcare industry), the sales volume of adalimumab in mainland China and worldwide for the year of 2023 was approximately RMB 948 million and USD 41.334 billion, respectively. The approval of the New Indications will further expand the therapeutic area of HANDAYUAN to the gastroenterology and pediatrics and provide more treatment options for patients with the relevant indications in mainland China.