Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced that the biologics license application (BLA) for Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) as monotherapy for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China for inclusion in the priority review and approval procedure. This BLA submission is based on the positive results from a pivotal registrational clinical study led by Professor Shen Lin of Peking University Cancer Hospital, which was designed to evaluate the efficacy and safety of Opamtistomig in patients with advanced EP-NEC whose disease had progressed following two or more prior lines of systemic therapy.

Under the relevant PRC regulations, the review timeline for a BLA included in the priority review and approval procedure is 130 working days, as compared with 200 working days under the ordinary review procedure. The inclusion of Opamtistomig in the priority review process represents a key milestone toward its commercialization, providing clarity and visibility on its expected approval timeline. The Company is actively advancing relevant pre-launch commercialization preparations.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The differentiated mechanism of Opamtistomig is translating into broad clinical value validation across multiple indications. Beginning with EP-NEC, a highly aggressive immune-cold tumor for which no globally approved therapy currently exists, and extending to larger indications such as NSCLC and BTC, we have strategically and systematically built a comprehensive clinical development program. Across these indications, we continue to observe meaningful survival benefits and encouraging efficacy signals. We remain committed to accelerating the clinical development of Opamtistomig and unlocking its full potential as a next-generation cornerstone immunotherapy."

Dr. Xiaoqiang Kang, Founder, Chairman, CEO of Leads Biolabs, added: "The inclusion of Opamtistomig's BLA in China's priority review is a pivotal step in Leads Biolabs' transition toward commercialization. This milestone not only reflects our decade-long commitment to differentiated innovation, but also underscores the regulatory authorities' strong emphasis on addressing unmet medical needs. We will work closely with the CDE throughout the review process and strive to bring this innovative therapy to patients as quickly as possible."