In recent years, Shanghai has continuously promoted the development of innovative drugs and ushered in a shining moment. As of 2025, a total of 8 domestically produced Class 1 innovative drugs in Shanghai have been approved for market by the National Medical Products Administration.
It is reported that recently, the National Medical Products Administration conditionally approved the application of Lepu Biotechnology Co., Ltd. for the listing of injectable vedicotuzumab (trade name: Meiyouheng) through the priority review and approval process. This is the 8th domestically produced Class 1 innovative drug approved for market in Shanghai this year. This product belongs to antibody conjugated drugs (ADCs) and is suitable for treating adult patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed to receive at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitors. The launch of this variety provides new treatment options for relevant patients.
In addition to the above-mentioned products, the other 7 innovative drugs are Renichiolumab Injection from Shanghai Hengrun Dasheng Biotechnology Co., Ltd., Luvomertinib Tablets from Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., Golelafenib Citrate Tablets from Shanghai Ailisi Pharmaceutical Technology Co., Ltd., Valarginase β for Injection from Beihai Kangcheng (Shanghai) Biotechnology Co., Ltd., Popadakoji Injection from Shanghai Xinzhi Pharmaceutical Technology Co., Ltd., Senapalli Capsules from Shanghai Yingpai Pharmaceutical Co., Ltd., and Esupaglutide Alpha Injection from Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Among them, Renichiolon injection was approved for market in July this year for the treatment of adult relapsed or refractory large B-cell lymphoma after second-line or above systemic treatment, including diffuse large B-cell lymphoma non-specific type, follicular lymphoma transformed diffuse large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangement, and high-grade B-cell lymphoma non-specific type.
Luvometinib tablets were approved for marketing in May as a highly selective MEK1/2 inhibitor. The two indications for this drug approval are for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytosis, as well as children and adolescents aged 2 years and older with type I neurofibromatosis (NF1) accompanied by symptoms and inoperable plexiform neurofibromatosis (PN). The dual indication approval of this product provides a new treatment option for patients in the field of rare tumors.
In May, citrate golelase tablets were also approved for marketing in adult patients with advanced non-small cell lung cancer (NSCLC) who have received at least one systemic treatment for KRAS G12C mutation. This is another innovative lung cancer drug approved for marketing by Elise, which will bring new treatment options for KRAS G12C mutation non-small cell lung cancer (NSCLC) patients and reshape the KRAS G12C mutation treatment pattern.
Another product approved for market in May of this year is the injection of Valarginase β, which is suitable for long-term enzyme replacement therapy in adolescents aged 12 and above and adult patients with type I and III Gaucher's disease.
Bopida Keji Injection was approved for marketing in April for the treatment of adult patients with moderate to severe hemophilia B (congenital factor IX deficiency). Hemophilia B is a hemorrhagic disease caused by a deficiency of coagulation factor IX (FIX). Popadaki injection is a recombinant adeno-associated virus (rAAV) vector gene therapy product, which introduces the FIX gene into target cells (mainly liver cells) through the rAAV vector to express FIX. The launch of this product provides a new treatment option for adult patients with moderate to severe hemophilia B.
Senapali capsules were approved for marketing in January and are suitable for maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission with first-line platinum based chemotherapy. Yisupaglutide alpha injection was also approved for marketing in January. It is applicable to the blood sugar control of adult type 2 diabetes patients.
Shanghai's remarkable achievements in the development of new drugs cannot be achieved without strong policy support and abundant resource investment. In terms of policy support, Shanghai has always actively responded to the national call and introduced a series of favorable policies based on its own actual situation. Policies such as the "Several Opinions on Supporting the Innovative Development of the Whole Chain of the Biomedical Industry" have established a full chain support system; Introduce special action plans around cutting-edge fields such as synthetic biology, cell and gene therapy, high-end medical devices, and brain computer interfaces to seize new opportunities for development; Actively promoting reform and innovation measures, actively undertaking national reform pilot tasks, including steadily advancing pilot projects for segmented production of domestic biological products, and actively promoting the orderly opening up of foreign investment in genetic diagnosis and treatment business.
With the approval and listing of a batch of innovative drugs, the scale of Shanghai's biopharmaceutical industry has also achieved continuous growth. Data shows that the scale of Shanghai's biopharmaceutical industry has grown from 761.714 billion yuan in 2021 to 984.702 billion yuan in 2024, with an average annual compound growth rate of 8.94%, and is expected to exceed 1 trillion yuan this year.