Reporter |
On August 9, Simcere announced the official market launch of Enrele® (abatacept injection), an innovative immunotherapy for autoimmune diseases developed in collaboration with Bristol-Myers Squibb in China. This product is currently the only approved T-cell selective costimulation modulator in the global field of rheumatoid arthritis and represents Simcere’s second commercialized drug in the treatment of rheumatoid arthritis.
Abatacept, developed by Bristol-Myers Squibb, is the first and currently the only T-cell co-stimulation modulator in the global field of rheumatology and immunology. It binds to CD80/CD86 on the surface of antigen-presenting cells, thereby blocking their interaction with CD28 on the surface of T cells. This inhibits autoantigen-induced T-cell activation and attenuates downstream inflammatory responses, exerting its therapeutic effect. In the field of rheumatoid arthritis, abatacept demonstrates superior efficacy in patients with anti-citrullinated protein antibodies (ACPA)-positive rheumatoid arthritis compared to those who are ACPA-negative.
Abatacept was approved in the United States in 2005, with global sales nearing $3 billion in 2019. Under the collaboration agreement between Simcere and Bristol-Myers Squibb, Simcere is responsible for clinical research and commercial promotion in mainland China.
Data indicates that the prevalent patient population in the field of rheumatoid arthritis (RA) exceeds 60 million. However, according to Professor Zeng Xiaofeng, Director of the National Clinical Research Center for Dermatologic and Immunologic Diseases and Vice President of the Asia Pacific League of Associations for Rheumatology (APLAR), data shows that the treatment target attainment rate for RA in China is only 8.6%. Price is a constraining factor influencing patients’ choices. Previously, foreign biologics such as adalimumab and tocilizumab were paid out-of-pocket; the need for long-term medication imposed a substantial disease burden on patients. However, with several biologics—including AbbVie’s Humira, Roche’s Actemra, and 3SBio’s Etanercept—being included in the National Reimbursement Drug List in recent years, the patient burden has been significantly reduced, and the domestic RA medication market is expected to experience rapid growth. The inclusion of abatacept will further intensify competition in the autoimmune disease market, which already features multiple blockbuster drugs such as adalimumab, infliximab, and tofacitinib.
Tang Renhong, Senior Vice President and Executive Director of Simcere, told Jiemian News that abatacept is currently priced at 6,000 yuan per month, and Simcere has assembled a medical professional team of approximately 60 members to promote the drug. Looking ahead, Simcere plans to deploy 1,500 dedicated sales representatives in its rheumatology and autoimmune disease therapeutic area, striving to achieve comprehensive coverage of all rheumatology departments, including combined rheumatology units, at the county level across China.
A comparison of prices reveals that abatacept holds no pricing advantage over drugs included in the National Reimbursement Drug List, such as adalimumab; this may also serve as a precursor to subsequent price reductions aimed at gaining inclusion in the national reimbursement list.
It is also worth noting that in recent years, Simcere has initiated multiple external collaborations and introduced several overseas products. In addition to abatacept, in March this year, Simcere entered into a collaboration agreement with Alphamab Oncology and 3D Medicines, securing exclusive rights to promote KN035, a subcutaneously injectable PD-L1 monoclonal antibody, for all oncology indications in China. On August 3, Simcere signed an exclusive licensing agreement with G1 Therapeutics, valued at up to $170 million, obtaining the development and commercialization rights for the latter’s CDK4/6 inhibitor across all indications in the Greater China region. Additionally, Simcere has other products under development, including a bevacizumab biosimilar in collaboration with Amgen, and seviperstat (APX005M), co-developed with Apexigen.
Although the collaboration with Merck & Co. in the past was hardly a success, it clearly did not hinder Simcere from continuing to pursue external partnerships. Tang Renhong told Jiemian News that the current focus of external in-licensing is on products in Phase II or III clinical trials that have no similar counterparts in China or for which there is still substantial domestic demand. For early-stage projects, emphasis is placed on those with breakthrough potential or high technical barriers.