今年第二季度，11款抗肿瘤新药有望获批上市

Core Insights - The oncology sector remains a hot area for innovative drug development, with significant unmet clinical needs driving pharmaceutical companies to invest in new treatments. In Q2 2024, 11 new anti-tumor drugs are expected to receive approval in China, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) [1]. Group 1: Drug Approvals and Regulatory Changes - The National Medical Products Administration (NMPA) has introduced expedited review processes for drug approvals, reducing the standard review time from 200 days to 130 days, and for urgently needed rare disease drugs from 200 days to 70 days [1]. - Among the 11 new drugs, three target the HER2 receptor, including Heng Rui Medicine's ADC, Zymeworks/Biocytogen's bispecific antibody, and Kelun-Biotech's ADC, each with different indications [2]. Group 2: Specific Drug Developments - Heng Rui Medicine's ADC, Rui Kang Qu Mo Zhu Dan, is the first domestic HER2 ADC for non-small cell lung cancer, with its application accepted on September 14, 2024, and recognized as a breakthrough therapy [2]. - Zymeworks' bispecific antibody, Zenida Mo Zhu Dan, received acceptance for its application on June 7, 2024, targeting HER2-positive cholangiocarcinoma, and was accelerated approved by the FDA in November 2024 [2]. - Kelun-Biotech's Bo Du Qu Mo Zhu Dan is expected to be approved for HER2-positive breast cancer treatment in Q2 2024, with its application accepted on May 11, 2023 [3]. Group 3: Other Notable Drug Candidates - Two new drugs for breast cancer and lymphoma are also expected to be approved, including G1 Therapeutics' oral CDK4/6 inhibitor for HR-positive, HER2-negative breast cancer and Xencor's monoclonal antibody for diffuse large B-cell lymphoma [4]. - The original drug Lomustine, used for Hodgkin's lymphoma and brain tumors, is set for its first domestic approval, with its application accepted on February 6, 2024 [5]. - Innovative drug Luwo Meitini from Fosun Pharma targets rare diseases and has two indications accepted for review in 2024 [6]. - The drug Suweisi Tanshu, a new generation anti-VEGF monoclonal antibody, aims to provide new treatment options for platinum-resistant ovarian cancer patients [6]. - The drug Golaileisi is expected to be approved for treating KRAS G12C mutation non-small cell lung cancer, with ongoing clinical trials for other solid tumors [6]. - Jikaxitini, a drug for myelofibrosis, is predicted to receive approval in Q2 2024, with its application accepted on October 17, 2022 [7].