双抗行业系列报告（一）：从肿瘤到自免，TCE双抗迎来新机遇

Investment Rating - The industry investment rating is "Outperform" [1] Core Insights - TCE bispecific antibodies (BsAbs) have shown strong therapeutic effects in hematological malignancies, with CD20/CD3 bispecific antibody achieving a complete response (CR) rate of 50% in patients with ≥2L relapsed or refractory DLBCL, offering a cost advantage over CAR-T therapies [2][62] - The development focus for the next generation of TCE bispecific antibodies is on reducing cytokine release syndrome (CRS) and improving response rates [73][45] - The application potential of TCE bispecific antibodies in autoimmune diseases is broad, with preliminary evidence of efficacy [3][140] Summary by Sections Hematological Malignancies - TCE bispecific antibodies are currently primarily approved for treating hematological malignancies, with a significant number of products in clinical development [22][38] - The focus on reducing CRS and improving response rates is critical for the development of new TCE bispecific antibodies [45][73] - The FDA has approved 13 bispecific antibodies, with 8 being TCE bispecific antibodies, indicating a strong market presence [13][22] Autoimmune Diseases - TCE bispecific antibodies have shown potential in treating autoimmune diseases, with ongoing clinical trials exploring their efficacy [140][143] - The market for TCE bispecific antibodies in autoimmune diseases is expected to grow, as evidenced by significant investments and collaborations in this area [140][191] - The safety profile of TCE bispecific antibodies in autoimmune diseases is promising, with low rates of severe adverse events reported in early trials [78][90] Market Dynamics - The market for TCE bispecific antibodies is experiencing rapid growth, particularly in China, with numerous transactions and collaborations indicating strong investor interest [29][48] - The competitive landscape is evolving, with multiple companies developing TCE bispecific antibodies targeting various antigens, including CD19, CD20, and BCMA [191][192] - The potential for TCE bispecific antibodies to coexist with CAR-T therapies in the treatment of hematological malignancies and autoimmune diseases presents both opportunities and challenges [169][190]