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40401,21,2026 104 views
【Pharmaceutical Network Industry Trends】At the beginning of 2026, China's innovative drug field will see intensive breakthroughs. According to the website of the Drug Evaluation Center of the National Medical Products Administration, since January 2026, six innovative drugs have been included in the list of breakthrough treatment varieties, from domestic and foreign pharmaceutical companies such as Zhejiang Daoer Biotechnology, Rongchang Biotechnology, Suzhou Shengdia Biotechnology, Shanghai Ailis, Kelombotai, Bayer, etc.
Among them, DR10624 injection from Zhejiang Daoer Biotechnology was included in the breakthrough therapy on January 10th, intended for severe hypertriglyceridemia. According to the data, DR10624 is a long-acting three specific agonist independently developed by Doer Biotech, targeting fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon like peptide-1r receptor (GLP-1R). DR10624 is a chimeric peptide targeting GLP-1R/GCGR at the N-terminus, fused with engineered IgG1 Fc, and fused with a recombinant FGF21 mutant at the C-terminus of Fc. The product has successfully completed phase II clinical research on severe hypertriglyceridemia (SHTG) and obtained positive top line results after unblinding.
Rongchang Biotech's injectable vediximab was included in breakthrough therapy on January 9th, with the proposed indication being first-line treatment of HER2 overexpressing advanced gastric/gastroesophageal junction adenocarcinoma using vediximab combined with trastuzumab and terilelizumab. Data shows that vediximab is an ADC drug developed by Rongchang Biotechnology, which targets the HER2 protein on the surface of tumors and can accurately identify and kill tumor cells. At the annual meeting of the American Society of Clinical Oncology (ASCO) in 2025, the results of a study on the first-line treatment of locally advanced or metastatic gastric cancer with HER2 expression using vediximab combined with trastuzumab and chemotherapy/trastuzumab were announced.
The injection SHR-1826 of Suzhou Shengdia Biotechnology was also included in the breakthrough therapy on January 9th, with the proposed indication being the monotherapy of injection SHR-1826 for the treatment of c-Met overexpression (2-3+, ≥ 50%) driver gene negative locally advanced or metastatic non squamous non-small cell lung cancer that has previously received at least first-line systemic treatment failure. SHR-1826 for injection is an antibody drug conjugate (ADC) independently developed by the company, targeting c-Met. It binds specifically to the target antigen on the surface of tumor cells and is internalized to kill tumor cells.
In addition, on January 5th, Shanghai Ailisi's famotinib mesylate tablets were included in breakthrough therapy, which is suitable for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with epidermal growth factor receptor (EGFR) PACC mutations. Kolombotai's injectable SKB264 is included in breakthrough therapy, and SKB264 combined with pembrolizumab is used as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 1% and epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative. Bayer's BAY 2927088 tablets are included in breakthrough therapy, and Sevabertinib (BAY 2927088) is suitable for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations.
In addition to the products that have already been included in breakthrough therapies, there are currently four other products that are planned to be included in breakthrough therapies, including Chengdu Zeling Biopharmaceutical's flunominib maleate tablets, which are intended for BCR-ABL fusion gene (Ph) negative bone marrow proliferative tumors; WXFL10030390 tablets from Shanghai Jiatan Pharmaceutical Technology are intended for recurrent or metastatic cervical cancer with PIK3CA mutations that have failed platinum based chemotherapy and immune checkpoint inhibitor treatment; DS-6000a from China is intended for the treatment of adult patients with platinum resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have previously received treatment with bevacizumab and express CDH6; SENL101 autologous T cell injection from Hebei Senlang Biotechnology is intended for adult relapsed or refractory T-cell lymphoma/leukemia (T-LBL/ALL).
The advancement of these breakthrough therapies may accelerate the benefits of innovative achievements to patients and also promote the innovation and transformation of China's pharmaceutical industry. In the future, as more innovative drugs enter the clinical and market stages, the accessibility and efficacy of major disease treatments in China will continue to improve.
Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone.
