40 Class 1 New Drugs in Pipeline! Hansoh Pharma's Deep Commitment to Innovation Drives Rapid Transformation

　　【Pharmaceutical Network Enterprise NewsAccording to the 2023 earnings report recently released by Hansoh Pharma, the company's innovative drug revenue achieved a breakthrough. In 2023, the revenue from its innovative drugs and collaborative products reached approximately 6.865 billion yuan, representing a year-on-year increase of 37.1%, and accounting for 67.9% of total revenue.
 

After nearly 30 years of development, Hansoh Pharma has become an innovation-driven Big Pharma in China. Currently, it has seven innovative drugs approved for marketing, with 42 new drugs in the clinical application stage or above, including 40 Class 1 new drugs and one imported Class 5.1 new drug, covering key areas such as oncology, anti-infectives, central nervous system, metabolic disorders, and autoimmune diseases.
 

Recently, Hansoh Pharma announced that "HS-10504 Tablets," a Class 1 new drug independently developed by its subsidiaries, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Shanghai Hansoh Biomedical Technology Co., Ltd., has received the clinical trial approval from the National Medical Products Administration. It is intended for the treatment of advanced non-small cell lung cancer, with the specific indications to be determined after clinical trials.
 

Phase I clinical data of the Class 1 innovative drug RET inhibitor (HS-10365) has been released at the 2023 American Association for Cancer Research (AACR) Annual Meeting. According to the published results of the Phase I dose-escalation study, HS-10365 demonstrated good safety, tolerability, and pharmacokinetic characteristics in advanced NSCLC patients with RET fusions who have no standard treatment options, cannot access or tolerate standard treatments, and showed superior anti-tumor activity. The ORR of HS-10365 in treatment-naïve NSCLC patients was 83.3%, while in previously treated NSCLC patients it was 66.7%. Among them, two subjects achieved complete response in target lesions, with the longest response duration exceeding 48 weeks, exhibiting remarkable and durable anti-tumor activity.
 

In addition, in July 2023, Hansoh Pharma also announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Ibrexafungerp Citrate Tablets, intended for the treatment of vulvovaginal candidiasis (VVC) in adult and postmenarcheal female patients. Data shows that this drug is a glycogen synthase inhibitor with a novel triterpenoid structure and represents a new mechanism of action among antifungal drugs. Both in vivo and in vitro studies have demonstrated that Ibrexafungerp possesses broad-spectrum antifungal activity and can be used to treat infections caused by drug-resistant strains, including azole- and echinocandin-resistant strains.
 

According to Hansoh Pharma's forecast, in the next three years, the company will file 8-10 IND applications and 2-3 NDA applications annually. By 2025, it will have over 15 innovative drugs (including new indications) on the market, and the revenue from innovative drugs will account for more than 80%.
 

Industry insiders say that drug innovation R&D capabilities, scientific development strategies, and efficient execution are becoming the long-term sustainable competitive advantages of Hansoh Pharma. In 2023, Hansoh Pharma continues to strengthen independent R&D, accelerate the connection with global resources, and has now built up a series of innovative drug pipelines at different R&D stages.
 

It is reported that anti-tumor is a key focus area for Hansoh Pharma. The company has laid out multiple targets including CDK4/6, EGFR, PIK3, c-Met, RET, Bcr-Abl, and HIF-2α, covering sub-categories such as lung cancer, breast cancer, ovarian cancer, leukemia, and renal cell carcinoma. In the ADC sector, Hansoh Pharma has differentiated its layout with promising targets like B7-H3 (HS-20093, Phase II) and B7-H4 (HS-20089, Phase II), demonstrating competitive advantages in both R&D speed and indication coverage.
 

Dedication to innovative R&D is the foundation of Hansoh Pharma's rapid transformation, but this would not be possible without continuous investment in R&D and an increasingly robust R&D team. Data shows that in 2023, the company's R&D expenditure increased by approximately 23.8% year-on-year, reaching about 2.097 billion yuan, accounting for 20.8% of total revenue.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.