Chinese Pharma Companies Announce Multiple R&D Milestones: New Indications, Clinical Approvals, and Late-Stage Trial Successes

　　【Pharmaceutical Network Product InformationOn October 23, Xingqi Pharmaceutical, BeOne Medicines, Kanghong Pharmaceutical, Hansoh Pharma and other pharmaceutical companies announced new progress in their R&D, including clinical approvals and new indications.
 

　　BeOne Medicines: Tislelizumab Approved for New Indication
 

BeOne Medicines announced that its PD-1 inhibitor, tislelizumab (BeiGene's Baizean), has been approved by the National Medical Products Administration (NMPA) for neoadjuvant treatment in combination with platinum-based chemotherapy, followed by adjuvant treatment with this product as a single agent after surgery, for the treatment of patients with resectable stage II or IIIA non-small cell lung cancer (NSCLC). This is the first PD-1 drug approved in China for neoadjuvant plus adjuvant immunotherapy in patients with stage II-III NSCLC, offering a new treatment option for patients.
 

As of now, tislelizumab has received approval from the National Medical Products Administration for 14 indications, 11 of which have been included in the National Reimbursement Drug List.
 

　　Kanghong Pharmaceutical: NASH Class 1 New Drug Approved for Clinical Trials
 

Kanghong Pharmaceutical announced that the company's Class 1 new drug KH629 tablets have received clinical trial implied permission, with the indication being adult non-alcoholic steatohepatitis.
 

According to reports, KH629 is a thyroid hormone β receptor selective agonist independently developed by the company. It belongs to the Class 1 innovative chemical drug, and its formulation is an oral solid dosage form tablet.
 

Non-alcoholic steatohepatitis (NASH/MASH) is a common liver disease in China. According to relevant reports, the market size of MASH drugs in China is predicted to grow to 35.5 billion yuan by 2030. Currently, numerous pharmaceutical companies worldwide are conducting research and development in this field of disease treatment.
 

　　Hansoh Pharma: Ameile Phase III Clinical Trial Meets Primary Endpoint
 

Hansoh Pharma announced that the Phase III registrational trial AENEAS2, which evaluated the efficacy of Almonertinib (Ameile) combined with chemotherapy as a first-line treatment for locally advanced (Stage IIIB to IIIC) or metastatic (Stage IV) epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC), has met its primary endpoint of progression-free survival (PFS).
 

It is reported that Amelie combined with chemotherapy has demonstrated statistically significant and clinically meaningful improvement in PFS among patients with advanced lung cancer with EGFR mutations. Detailed results of the study will be presented at future medical conferences and submitted to regulatory authorities.
 

Lung cancer is a malignant tumor with a very high incidence rate in China, among which non-small cell lung cancer (NSCLC) is the most common type. There remains a significant unmet treatment need for patients. With the advancement of research on Almonertinib (Ameile) combined with chemotherapy, it may offer a new treatment option for patients.
 

　　Xingqi Pharmaceutical: Summary Report Obtained for Multiple Specifications of Atropine Research
 

Xingqi Pharmaceutical announced that the Phase III study of Atropine Sulfate Ophthalmic Solution (0.02% and 0.04%) developed by the company for delaying the progression of myopia in children has been summarized in a final report. The study results showed statistically significant differences in primary efficacy endpoints between the 0.02% and 0.04% Atropine Sulfate Ophthalmic Solution groups compared to the placebo group. The Atropine Sulfate Ophthalmic Solution groups demonstrated superiority over the placebo group, with good safety and strong patient compliance.
 

To date, no 0.02% and 0.04% atropine sulfate eye drops have been approved for marketing in China or abroad.
 

In addition, the company's developed Atropine Sulfate Eye Drops recently received a clinical summary report titled "A Randomized, Double-blind, Placebo-controlled Parallel-group, Multi-center 2-year Clinical Trial on the Efficacy and Safety of Atropine Sulfate Eye Drops (0.01%) in Delaying the Progression of Myopia in Children."
 

The study results showed that, compared with the placebo group, the Atropine Sulfate Eye Drops group demonstrated a statistically significant difference in the primary efficacy endpoint. The Atropine Sulfate Eye Drops group outperformed the placebo group, exhibited good safety, and showed high patient compliance.
 

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