Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested additional documentation from 12 companies, including Chaimai Biotech, regarding compliance with foreign investment policies prior to their public listing [1][2]. Group 1: Regulatory Requirements - CSRC has asked Chaimai Biotech to provide a conclusive legal opinion on the legality of past equity changes of its main domestic operating entity, including compliance with foreign exchange registration and foreign investment regulations [2]. - The company is required to clarify the establishment and equity changes of its largest shareholder, Sanaron Inc., and the relationship between the actual controller and trust beneficiaries [2]. - Chaimai Biotech must also disclose the natural person shareholders of Everlasting Wisdom Holdings Limited, which holds 5.37% of its shares, and explain the reasons and fairness of their investment [2]. Group 2: Business Overview - Chaimai Biotech is a clinical-stage biotechnology company focused on developing T-cell engagers for treating various cancers and autoimmune diseases [3][4]. - The company's oncology pipeline includes three clinical-stage candidates: EMB-01 for colorectal cancer, EMB-06 for multiple myeloma, and EMB-07 for lymphoma and solid tumors [4]. - Additionally, Chaimai Biotech has three preclinical candidates targeting different antigens, as well as an immunology pipeline with one clinical-stage candidate and two preclinical candidates [4].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested additional documentation from 12 companies, including Chaimai Biotech, regarding compliance with foreign investment policies prior to their public listing [1][2]. Group 1: Regulatory Requirements - Chaimai Biotech is required to clarify the legality of its domestic operational entity's past equity changes and compliance with foreign exchange registration and investment regulations [2]. - The CSRC has asked for a detailed explanation of the establishment and equity changes of the largest shareholder, Sanaron Inc., and its relationship with the actual controller and trust beneficiaries [2]. - The company must provide information on the natural person shareholders of Everlasting Wisdom Holdings Limited, which holds 5.37% of its shares, and explain the reasons and fairness of their investment [2]. Group 2: Business Overview - Chaimai Biotech is a clinical-stage biotechnology company focused on developing T-cell engagers for treating various cancers and autoimmune diseases [3][4]. - The company's oncology pipeline includes three clinical-stage candidates: EMB-01 targeting EGFR/cMET for colorectal cancer, EMB-06 targeting BCMA/CD3 for multiple myeloma, and EMB-07 targeting ROR1/CD3 for lymphoma and solid tumors [4]. - Additionally, Chaimai Biotech has three preclinical candidates in its pipeline, along with an immunology candidate, EMB-06, which is also in clinical stages [4].

Core Viewpoint - The announcement from Valiant Biopharma-B (09887.HK) highlights significant progress in the clinical research of LBL-034, a bispecific antibody targeting GPRC5D/CD3, with promising Phase I data and the successful treatment of the first patient in Phase II trials [1] Group 1: Clinical Trial Results - The Phase I trial of LBL-034 involved over 50 patients with relapsed/refractory multiple myeloma, showing positive efficacy signals and good safety at a dose of 1,200 μg/kg [1] - The overall response rate was robust, with a higher rate of complete response or deeper responses (≥CR) and minimal residual disease (MRD) negativity compared to current standard therapies [1] - Notably, significant efficacy was observed in the difficult-to-treat extramedullary (EMD) myeloma patient subgroup [1] Group 2: Future Developments - Detailed results from the study are set to be presented at the 2025 American Society of Hematology (ASH) annual meeting [1] - The Phase II trial is a multicenter, single-arm, multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The aim of the Phase II trial is to evaluate the efficacy and safety of LBL-034 in various relapsed/refractory plasma cell tumors [1]

Group 1 - The core viewpoint of the news is that Anmai Biotech has submitted its listing application, with CITIC Securities and China Merchants International Capital serving as joint sponsors [1] - Anmai Biotech, established in 2015, is a clinical-stage biotechnology company focused on developing T-cell engagers for treating various cancers and autoimmune diseases [1] - The oncology pipeline includes three clinical-stage candidates: EMB-01 targeting EGFR/cMET for colorectal cancer, EMB-06 targeting BCMA/CD3 for multiple myeloma, and EMB-07 targeting ROR1/CD3 for lymphoma and solid tumors [1] Group 2 - Anmai Biotech's core business model leverages nearly a decade of experience in the field, utilizing proprietary bispecific antibody platforms and CD3 binding domain libraries for the discovery, development, and commercialization of bispecific antibodies and T-cell engagers [2] - As of the end of 2023, Anmai Biotech has established multiple global licensing collaborations with a total transaction value exceeding $2.1 billion, ranking second globally in the T-cell engager field [2] - Financially, Anmai Biotech is projected to generate approximately 459 million RMB in revenue for the fiscal year 2024, with a loss of 595 million RMB in 2023 and a profit of 48 million RMB anticipated for 2024 [2]