Group 1 - The core point of the article is that the first patient has successfully received treatment with the drug Opalizumab (LBL-024) in a Phase Ib/II clinical trial for recurrent or metastatic triple-negative breast cancer (TNBC) [1] - The clinical trial is an open-label, multi-center study led by Professor Yin Yongmei from Jiangsu Provincial People's Hospital, aiming to evaluate the efficacy and safety of Opalizumab alone or in combination with albumin-bound paclitaxel for TNBC patients [1] - The drug Opalizumab is a bispecific antibody targeting both PD-L1 and 4-1BB, and it is the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage for extra-pulmonary neuroendocrine carcinoma [2] Group 2 - In two clinical trials in China, Opalizumab has shown encouraging efficacy signals and good safety profiles, whether used as a monotherapy or in combination with chemotherapy for advanced extra-pulmonary neuroendocrine carcinoma [3] - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial and obtained breakthrough therapy designation (BTD) in October 2024 for treating advanced extra-pulmonary neuroendocrine carcinoma [3] - Cancer is a leading cause of morbidity and mortality globally, with breast cancer being the second most common cancer after lung cancer, and TNBC represents a subtype with high malignancy and poor prognosis, accounting for about 15% to 20% of all breast cancer cases [4]

Group 1 - The stock of Valiant Pharmaceuticals (09887) has increased by over 5%, currently trading at 72.5 HKD with a transaction volume of 86.43 million HKD [1] - On August 14, the company announced the completion of patient enrollment for the pivotal single-arm clinical study of Opalizumab (LBL-024), a PD-L1/4-1BB bispecific antibody [1] - Opalizumab (LBL-024) is the first bispecific antibody targeting both PD-L1 and 4-1BB, currently in pivotal clinical stages, and is expected to be the first approved drug for treating EP-NEC [1] Group 2 - The 4-1BB agonist can reactivate apoptotic T cells and significantly expand their numbers, making it particularly suitable for treating PD-1/PD-L1 resistant or ineffective cold tumors [2] - Besides EP-NEC, Opalizumab has received approval for clinical studies in several cancers with high unmet clinical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma [2] - Promising clinical results have been observed in multiple cancer types such as SCLC, BTC, and OC, indicating the potential of Opalizumab as an effective anti-tumor drug with broad indications [2]