RemeGen and Hansoh Pharma Secure New Indications for Their Innovative Therapies

May 12, 2025 18:11 CST Updated 18:11

RemeGen

Biological New Drug Developer

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

As one of the regions in China with the most complete biopharmaceutical industry chain, the best ecosystem, the most concentrated talent pool, and the most active innovation, Zhangjiang is continuously improving its innovation ecosystem to facilitate the constant emergence of innovative achievements. Just recently,RemeGen、Hansoh PharmaNew indications have been successively approved, providing more patients with new treatment options.

Among them, RemeGen's Disitamab Vedotin became the world’s first approved ADC drug for HER2-positive advanced breast cancer patients with liver metastases. This is the third indication for which Disitamab Vedotin has been approved in China.

Hansoh Pharma Amelo^®The Fourth Indication Approved for Marketing, Continuing to Lead China's Self-Developed Third-Generation EGFR-TKI.

World's First: RemeGen's Disitamab Vedotin Third Indication Approved for Marketing

May 9,RemeGenAnnounced its self-developed original antibody-drug conjugate (ADC) Disitamab Vedotin (RC48, Aidi Xi^®) has been officially approved for marketing by the National Medical Products Administration (NMPA) for HER2-positive advanced breast cancer patients with liver metastases who have previously received trastuzumab or its biosimilars and taxane-based drugs.

This is also the world's first approved ADC drug for HER2-positive advanced breast cancer patients with liver metastases. Previously, Vidcentuximab had been approved for two indications: HER2-overexpressing locally advanced or metastatic gastric cancer and HER2-overexpressing locally advanced or metastatic urothelial carcinoma.

Dr. Jianmin Fang, CEO of RemeGenBreast cancer poses a serious threat to the life and health of patients, with significant unmet clinical needs. Disitamab vedotin is the first and only approved ADC drug for HER2-positive breast cancer with liver metastases, offering an innovative treatment option that is both highly effective and less toxic for these patients. We find this very valuable and are deeply grateful to all the researchers and patients who have contributed to the clinical studies. Additionally, we have demonstrated in other clinical trials that disitamab vedotin shows encouraging efficacy and safety across breast cancer patients with varying levels of HER2 expression. We are also actively exploring its potential in combination with other drugs, hoping to expand the application of this drug in the future to benefit a broader patient population.

The fourth item, Hansoh Pharma Ameile^®New Indication Approved for Marketing

Also on May 9,Hansoh PharmaAnnouncement, Ameile^®(Aumolertinib Mesylate Tablets) New Indication Approved for Marketing: For the treatment of adult patients with stage Ⅱ-ⅢB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Patients must have previously undergone surgical resection and may or may not receive adjuvant chemotherapy as determined by their physician. This approval enables Almonertinib...^®The number of approved indications in China has reached four, continuing to lead among China-developed third-generation EGFR-TKIs.

This approval is mainly based on ARTS (HS-10296-302), a randomized, double-blind, controlled, multi-center Phase III clinical study. The results were presented as an oral report at the 2025 American Association for Cancer Research (AACR) Annual Meeting.

Data from the ARTS study presented at the 2025 AACR confirmed that, for patients with completely resected stage II-IIIB EGFR-mutated NSCLC, Almonertinib (Ameile®) is an applicable treatment option.^®Adjuvant therapy can significantly improve patients' disease-free survival (DFS), with a 2-year DFS rate as high as 90.2%, HR of 0.17, and overall controllable safety. Notably, all patients included in the study are Chinese, demonstrating the efficacy of Almonertinib.^®Significant efficacy and controllable safety for patients in China.

As the first domestically developed third-generation EGFR-TKI in China, Amelotinib^®Since its market launch five years ago, it has continuously expanded its therapeutic areas. While consolidating its advantages in locally advanced or metastatic NSCLC (Stage III-IV), in March 2025, it successfully extended its therapeutic scope to unresectable locally advanced NSCLC (Stage III). With this approval, Almonertinib (Almeile)^®The application scope has been extended to early and mid-stage NSCLC (Stage II-III), achieving broader coverage of NSCLC, which will provide more treatment options and benefits for lung cancer patients in China.

Source: RemeGen, Hansoh Pharma