15 Innovative Drugs Granted Breakthrough Therapy Designation in January 2026, Led by Hengrui Medicine, Kelun-Biotech, and RemeGen

　　【Pharmaceutical Network Industry DynamicsAccording to the review, in January 2026, 15 innovative drugs were included in the list of breakthrough treatments, of which 11 are domestically produced innovative drugs in China, including HRS-5346 tablets and SHR-1826 from Hengrui Pharma, SKB264 for injection from Kelun-Biotech, Furmonertinib Mesylate tablets from Allist Pharmaceuticals, Disitamab Vedotin for injection from RemeGen, etc.
 

Among them, Hengrui Pharma has two innovative drugs included in the breakthrough therapy designation. These include SHR-1826 for injection, with the proposed indication being monotherapy using SHR-1826 for injection to treat c-Met overexpression (2-3+, ≥50%) driver gene-negative locally advanced or metastatic non-squamous non-small cell lung cancer that has failed at least one prior line of systemic therapy. The other drug is HRS-5346 tablets, with the proposed indication being the treatment of elevated lipoprotein(a) levels.
 

Zhongpeng (Xiamen) Biopharmaceutical Co., Ltd. also has two innovative drugs included in the breakthrough therapy, including NBB-002, with the proposed indication being advanced head and neck malignant tumors suitable for BNCT treatment (excluding nasopharyngeal cancer and intracranial tumors) according to the relevant requirements of therapeutic products, as well as the formulation of dosing regimens. Injectable Boron [10B] Phelhan has a proposed indication for advanced head and neck malignant tumors (excluding nasopharyngeal cancer and intracranial tumors) that have failed previous treatments.
 

In January, the domestically produced innovative drug included in the breakthrough therapy was Kelun-Biotech's SKB264 for injection. The proposed indication is for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥ 1%, negative epidermal growth factor receptor (EGFR) gene mutation, and negative anaplastic lymphoma kinase (ALK), in combination with pembrolizumab.
 

Allist Pharmaceuticals' Fumetinib Mesylate Tablets are intended for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) PACC mutations.
 

RemeGen's Disitamab Vedotin for Injection, the proposed indication is Disitamab Vedotin for Injection in combination with Trastuzumab and Toripalimab as first-line treatment for HER2 high-expressing advanced gastric/gastroesophageal junction adenocarcinoma;
 

Doer Biologics' DR10624 Injection, intended indication: for severe hypertriglyceridemia.
 

SENL101 Autologous T-cell Injection by senlangbio, with the proposed indication for adult relapsed or refractory T lymphoblastic lymphoma/leukemia (T-LBL/ALL);
 

Jiatan Pharma's WXFL10030390 tablets, with the proposed indication for recurrent or metastatic cervical cancer with PIK3CA mutations that have failed platinum-based chemotherapy and immune checkpoint inhibitor treatments;
 

Zenitar's Flunotinib Maleate Tablets: The proposed indication is BCR-ABL fusion gene (Ph)-negative myeloproliferative neoplasms.
 

In addition, four imported innovative drugs have been included in the breakthrough therapy designation, including Eli Lilly's tirzepatide injection, with the proposed indication being metabolic associated fatty liver disease (MAFLD);
 

Merck's pembrolizumab injection, with the proposed indication of pembrolizumab in combination with SKB264 for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥ 1%, negative epidermal growth factor receptor (EGFR) gene mutation, and negative anaplastic lymphoma kinase (ALK).
 

Daiichi Sankyo's DS-6000a, the proposed indication is for the treatment of adult patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have previously received bevacizumab treatment and express CDH6.
 

Bayer's BAY 2927088 tablets, with the proposed indication: Sevabertinib (BAY 2927088) is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations.
 

The inclusion of 15 innovative drugs in the list of breakthrough therapies this time reflects the continuous improvement of China's pharmaceutical innovation ecosystem. Looking ahead, the accelerated development and market entry of these breakthrough therapies will further diversify clinical treatment options.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.