Domestic Class 1 Innovative Drugs Achieve Breakthroughs Across Multiple Therapeutic Areas Within a Week

　　【Pharmaceutical Network | Industry Trends] Last week (June 16–22), the field of domestically developed Class 1 innovative drugs witnessed several key breakthroughs, including approvals for new indications, commercial shipments, inclusion in the priority review program, and clinical trial approvals. These advancements spanned multiple sectors, covering small molecules, bispecific antibodies, antibody-drug conjugates (ADCs), and AI-driven innovative drugs.
 

Recently, the China Investigators Meeting for the Phase III clinical trial of Rentosertib, an oral drug for the treatment of idiopathic pulmonary fibrosis, was held in Beijing, with plans to launch the clinical trial in July.
 

Rentosertib, developed by Insilico Medicine, features a novel target and molecular structure discovered and designed through AI-driven approaches, demonstrating first-in-class potential. Results from the Phase IIa clinical trial in September 2024 indicated that the candidate drug exhibited favorable safety and tolerability profiles. In patients receiving 12 weeks of treatment, dose-dependent improvements were observed in multiple endpoints, including forced vital capacity (FVC), suggesting a potential therapeutic trend toward reversing disease progression.
 

On June 18, ApicHope announced that its wholly-owned subsidiary, Guangzhou ApicHope Pharmaceutical Co., Ltd., had its application for clinical trial registration of APH03867 tablets, a Class 1 innovative drug independently developed by the company, accepted by the National Medical Products Administration. The drug is intended for the treatment of patients with gout accompanied by hyperuricemia.
 

APH03867 tablets are a novel oral, non-peptide small-molecule inhibitor of URAT1 (urate transporter 1). By inhibiting URAT1 activity, it blocks the reabsorption of uric acid in the renal tubules, increases uric acid excretion, and thereby effectively lowers serum uric acid levels. The drug has not been marketed either domestically or internationally and is classified as a Class 1 innovative chemical drug that has not been launched in any market.
 

On June 16, Sedomingji Injection (brand name: Huasuoling), a Class 1 innovative drug independently developed by Northland, passed the GMP compliance inspection conducted by the Beijing Municipal Drug Administration and received the relevant notification. During the same period, Jiangsu Yaohai Biopharmaceutical Co., Ltd., the contract manufacturing organization for the drug, also obtained the GMP compliance inspection notification issued by the Jiangsu Provincial Drug Administration.
 

The approved indication for Sedomingji Injection is limb ulcers caused by severe lower limb ischemia (such as arteriosclerosis obliterans of the lower extremities, thromboangiitis obliterans, and diabetic lower limb ischemia) in patients who are not suitable for revascularization surgery or have poor surgical outcomes.
 

On June 16, Alphamab Oncology’s HER2 bispecific antibody Enituo® (KN026) initiated its first commercial shipments across China. According to reports, Enituo® was approved for marketing in May 2026 through the National Medical Products Administration’s priority review and approval program. It is indicated for use in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing regimen.
 

On June 16, Henlius announced that the Phase III international multicenter clinical study (NCT04740671) of HLX04-O for wet age-related macular degeneration (wAMD) had successfully met its prespecified primary endpoint. Previously, the New Drug Application (NDA) for this drug in the treatment of wAMD had been accepted by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) of China.
 

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Overall, the intensive breakthroughs in domestically developed new drugs last week indicate that Chinese companies with a long-term commitment to independent R&D are beginning to reap the rewards; meanwhile, leading domestic pharmaceutical companies are continuing to focus on major indications, with their competitiveness steadily increasing.
 

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