Seven Innovative Drugs from Hansoh Pharma and Others Granted or Proposed for Breakthrough Therapy Designation

　　【Pharmaceutical Network Industry DynamicsAccording to the review, as of February 26, four innovative drugs have been included in the list of breakthrough treatments since February, involving companies including Hansoh Pharma (Shanghai) Biomedical Technology Co., Ltd., Haikou Pharmaceutical Factory Co., Ltd., Mingji Biopharmaceutical (Beijing) Co., Ltd., and Limin Pharmaceutical Technology (Shanghai) Co., Ltd.
 

Among them, the injectable HS-20093 developed by Shanghai Hansoh Biomedical Technology Co., Ltd. was approved by the National Medical Products Administration (NMPA) for inclusion in the breakthrough therapy designation on February 25. The indication is for the treatment of osteosarcoma patients who have progressed after at least two lines of therapy. This approval marks another significant advancement for the company in the field of cancer treatment.
 

Data shows that HS-20093 is a B7-H3-targeted ADC, covalently linked by a fully human anti-B7-H3 monoclonal antibody and a topoisomerase inhibitor payload. It is currently undergoing multiple clinical studies in China, with indications including lung cancer, sarcoma, head and neck cancer, and other solid tumors, the highest stage of research being Phase III clinical trials. Additionally, on November 1, 2024, HS-20093 received NMPA approval as a breakthrough therapy for extensive-stage small cell lung cancer that has progressed after standard first-line treatment. These advancements will further enhance the company's market competitiveness.
 

In addition to Hansoh Pharma's HS-20093 being included in the list of breakthrough therapies, since February, M108 Monoclonal Antibody Injection, a Class 1 new drug developed by Mingji Biopharma, has also been added to the list of breakthrough treatment varieties. The proposed indication is in combination with gemcitabine plus albumin-bound paclitaxel for first-line treatment of patients with locally advanced unresectable or metastatic CLDN18.2-positive pancreatic cancer. LM-108 Injection from Lixi Medicine has also been included in the list of breakthrough treatment varieties, with the proposed indication for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors who have experienced disease progression after treatment with immune checkpoint inhibitors (ICI). Fluofenitone capsules from Haikou Pharmaceutical Factory Co., Ltd. have also been included in the list of breakthrough treatment varieties, with the proposed indication for chronic hepatitis B-related liver fibrosis/cirrhosis.
 

According to the data, FG-M108 is a self-developed ADCC-enhanced monoclonal antibody targeting CLDN18.2 by Mingji Biotechnology. It targets CLDN18.2-positive tumor cells with moderate affinity and high specificity, and fully mobilizes the immune function of patients to kill tumors through enhanced ADCC effects. The preliminary clinical data of this product as monotherapy and combination therapy for advanced solid tumors has shown good safety and positive efficacy signals, demonstrating drug potential in various CLDN18.2-positive tumors.
 

In addition, three innovative drugs are proposed to be included in the list of breakthrough therapies. These include Orelabrutinib Tablets from Guangzhou Shunjiang Biomedical Technology Co., Ltd., with the proposed indication of Orelabrutinib combined with chemotherapy as a first-line treatment for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL); CT041 Autologous CAR T-cell Injection from Shanghai Coeus Pharmaceuticals Co., Ltd., with the proposed indication for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma that is Claudin18.2 (CLDN18.2) positive and has failed at least two prior lines of therapy; and Sirolimus (Albumin-bound) for Injection from Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., a subsidiary of CSPC, with the proposed indication of malignant perivascular epithelioid cell tumor. The public comment periods are from February 25, 2025, to March 4, 2025; from February 21, 2025, to February 28, 2025; and from February 20, 2025, to February 27, 2025, respectively.
 

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