Kelun-Biotech and Harbour BioMed secure NMPA approval for asthma drug

1 min read | Published on 15 Jul 2026, 03:43 PM |Updated on 15 Jul 2026, 03:43 PM

Reviewed by

Shriram SScanX News Team

Key Highlights

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Harbour BioMed received NMPA approval for SKB575/HBM7575 to treat asthma. The long-acting bispecific antibody targets TSLP and an undisclosed antigen, with potential dosing intervals exceeding three months. Kelun-Biotech leads global development, while Harbour BioMed co-develops the asset.

*this image is generated using AI for illustrative purposes only.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Harbour BioMed announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for SKB575/HBM7575 for the treatment of asthma. The drug is a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the two parties. This approval marks a significant step in addressing the unmet medical needs of asthma patients worldwide.

Clinical Progress and Mechanism

SKB575/HBM7575 has already initiated clinical trials for two chronic immune-mediated diseases: atopic dermatitis and asthma. The first participant was dosed in a Phase I clinical study for atopic dermatitis prior to this approval. The drug's dual mechanism of action involves blocking the interaction between TSLP and its receptor, thereby inhibiting TSLP-mediated signaling pathways and the activation of Th2 immune cells. Additionally, binding to and blocking the undisclosed target generates a synergistic effect, potentially achieving broader inflammation control compared to single-target approaches.

Drug Profile and Development

SKB575/HBM7575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy. Under the collaboration agreement, Kelun-Biotech leads the design, global development, and commercialization of SKB575/HBM7575, while Harbour BioMed participates in the investment and development of this asset and shares the benefits as agreed.

Company Backgrounds

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, focusing on the R&D, manufacturing, commercialization, and global collaboration of innovative biological drugs and small molecule drugs. The company targets major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases. Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, leveraging its proprietary Harbour Mice® platform.

Aspect	Details
Drug Name	SKB575/HBM7575
Targets	TSLP and an undisclosed antigen
Indication	Asthma
Administration Route	Subcutaneous
Dosing Interval	More than three months (anticipated)
Lead Developer	Kelun-Biotech
Collaborator	Harbour BioMed

What are the key milestones and timelines expected for the upcoming clinical trials for SKB575/HBM7575 in asthma?

How might the three-month dosing interval influence patient adherence and market positioning compared to current asthma therapies?

What regulatory hurdles could SKB575/HBM7575 face in international markets beyond China?

Kelun-Biotech partner doses first patients in Phase 2 COPD study

1 min read | Published on 09 Jun 2026, 06:38 PM |Updated on 09 Jun 2026, 06:38 PM

Reviewed by

Naman SScanX News Team

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Key Highlights

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and its partner Windward Bio have dosed the first patients in the Phase 2 SIRIUS study of SKB378/WIN378 for COPD. The drug, a potential first-to-market ultra long-acting anti-TSLP antibody, is also in a Phase 2/3 asthma study with data due in H2 2026. Phase 3 asthma trials are planned for Q4 2026.

*this image is generated using AI for illustrative purposes only.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its partner Windward Bio has dosed the first patients in the Phase 2 SIRIUS study of SKB378/WIN378 for chronic obstructive pulmonary disease (COPD). The study initiation expands the development of SKB378/WIN378 into a second major respiratory disease, addressing a condition that is the third leading cause of death worldwide. Despite existing therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, highlighting the need for new treatments.

Study Details

The SIRIUS study is a global, Phase 2 randomized, double-blind, placebo-controlled, dose-finding trial. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378/WIN378 in patients with moderate-to-severe COPD. The drug is a next-generation, fully human monoclonal antibody that inhibits the TSLP ligand, a target validated in immunological diseases such as asthma and COPD.

Development Pipeline

SKB378/WIN378 is currently being evaluated in the Phase 2/3 POLARIS asthma study, with initial Phase 2 data expected in the second half of 2026. The first Phase 3 study in asthma is planned for the fourth quarter of 2026. A Phase 1 trial confirmed an extended half-life suitable for twice-yearly dosing, a low rate of antidrug antibodies, and a safety profile that was well tolerated up to the highest dose tested.

Study	Phase	Indication	Status/Timeline
SIRIUS	Phase 2	COPD	First patients dosed
POLARIS	Phase 2/3	Asthma	Initial data H2 2026
Asthma Study	Phase 3	Asthma	Initiation planned Q4 2026

Corporate Background

SKB378/WIN378 originated as a co-development project between Kelun-Biotech and Harbour BioMed, with both parties equally sharing global rights. Windward Bio licensed the global rights, excluding Greater China and several Southeast and West Asian countries, for SKB378/WIN378. Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, focusing on innovative biological drugs and small molecule drugs for solid tumors, autoimmune, and metabolic diseases.

How will the upcoming Phase 2 data from the POLARIS asthma study in H2 2026 influence the strategic direction and investment focus for the COPD program?

Given the competitive landscape of TSLP inhibitors, what specific clinical advantages must SKB378/WIN378 demonstrate to capture market share from existing therapies like tezepelumab?

What are the potential regulatory and commercial implications of the global rights split between Windward Bio and Kelun-Biotech for the drug's eventual market launch?