Hansoh Pharma Submits Two New Innovative Drug Candidates, Bringing 2021 Filings to Nine

On July 28, the CDE's official website indicated that Hansoh Pharma consecutively filed applications for two innovative drugs, HS-10375 and HS-10381.

According to the Insight database, as of July 28, Hansoh Pharma's innovative drug pipeline comprises 32 products. In addition to five marketed new drugs, the pipeline includes 12 clinical-stage innovative drugs, 9 innovative drugs that have received clinical trial approval but have not yet initiated trials, and 6 innovative drugs currently under clinical trial application.

Notably, in recent years, Hansoh Pharma has significantly increased its R&D investment and accelerated innovative drug development. This year alone, Hansoh has already submitted applications for nine new innovative drug projects, one of which has already entered clinical trials.

2021 New Projects: Immunology, Oncology, Diabetes

Based on the disclosed information regarding Hansoh Pharma's newly filed and clinically initiated innovative drug projects in 2021, its pipeline spans multiple therapeutic areas, including HS-10360 and HS-10374 in the autoimmune field, the antitumor drug HS-10365, the dual-target antidiabetic agent HS-20094, and the psychiatric antidepressant HS-10353.

Among these, HS-20094 warrants particular attention. The GLP-1 drug sector is currently highly competitive, with the global market size reaching $12.4 billion in 2020 and continuing to grow, while domestic competition in China has also intensified. With the release of positive clinical data, the next-generation potential "blockbuster" antidiabetic drug may well emerge from the multi-target agonist field. Currently, among domestic companies with pipelines in this area, none except Innovent's IBI362 have initiated clinical trials. As a GLP-1R/GIPR dual agonist, Hansoh Pharma's HS-20094 holds promising future potential.

Biologics Gain Momentum

On July 15, Hansoh Pharma consecutively submitted applications for two Class 1 therapeutic biologics, HS-20093 and HS-20089, both of which were accepted by the CDE. This marks Hansoh's strategic expansion into the biologics sector. Since 2020, Hansoh Pharma has had four biologics applications under review by the CDE, including one pending production approval, one in Phase I clinical trials, and two at the IND stage.

The first biologic drug filed by Hansoh Pharma is inebilizumab, a CD19 monoclonal antibody licensed from Viela Bio, which is a first-in-class novel drug for neuromyelitis optica spectrum disorder (NMOSD). The collaboration between Hansoh and Viela Bio was established on May 28, 2019. Under this agreement, Hansoh paid an upfront fee, milestone payments exceeding $220 million, and tiered royalties based on net product sales. In October 2020, the marketing approval application for inebilizumab was filed in China.

In addition, Hansoh's fastest-advancing biologic drug is HS-20090, a denosumab biosimilar, which initiated Phase I clinical trials in September 2020.

Currently, Hansoh Pharma has established a biologics R&D center, with its product pipeline covering monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and fusion proteins. Looking ahead, Hansoh's biologics innovation R&D is poised to enter a fast track, ushering in a new chapter of innovative development and the transformation and upgrading of its product portfolio.