Harbour BioMed Receives NMPA IND Clearance for HBM9378/SKB378 in COPD Treatment

Harbour BioMed’s TSLP Antibody Gathers Steam for COPD Treatment

In a significant leap forward for COPD treatment,Harbour BioMed,a global biopharmaceutical company,has received approval from China’s National Medical Products Governance (NMPA) for its innovative TSLP antibody,HBM9378/SKB378. This Investigational New Drug (IND) approval paves the way for crucial clinical trials that will assess the drug’s potential to improve the lives of millions affected by this debilitating respiratory disease.

COPD, a progressive and chronic lung condition, poses a significant burden on both individuals and healthcare systems worldwide.Characterized by debilitating symptoms like shortness of breath and persistent cough, COPD carries a high risk of complications, impacting quality of life and life expectancy. “This regulatory clearance from the NMPA is a pivotal milestone in our pursuit of addressing the critical unmet needs in immunological diseases,” said Dr. Jingsong Wang, Founder, Chairman, and CEO of harbour BioMed.”HBM9378/SKB378 represents a potential best-in-class, long-acting TSLP antibody with remarkable biophysical properties. We are committed to exploring its full therapeutic potential to benefit patients globally.”

HBM9378/SKB378 works by targeting thymic stromal lymphopoietin (TSLP), a key player in triggering airway inflammation, the driving force behind COPD progression. By effectively blocking the interaction between TSLP and its receptor, the antibody aims to inhibit the TSLP-mediated signaling pathway, ultimately reducing airway inflammation and improving lung function in patients.

A Global Collaboration for Innovative Treatment

Harbour BioMed’s strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.(“Kelun-Biotech”) and Windward Bio has amplified the drug’s potential reach. This collaborative agreement ensures global access to this promising treatment, signifying a commitment to bringing innovative therapies to patients worldwide.

HBM9378/SKB378’s individualized approach to COPD treatment, targeting the root cause of airway inflammation, offers immense hope for patients seeking relief from debilitating symptoms and improved quality of life. as the clinical trials progress and shed further light on the antibody’s effectiveness, we can anticipate a paradigm shift in COPD management, ushering in a new era of hope for millions struggling with this chronic condition.

Harbour BioMed’s TSLP Antibody: A Breath of Fresh Air for COPD Treatment

Harbour BioMed, a global biopharmaceutical company, is making waves in the fight against chronic obstructive pulmonary disease (COPD) with its promising next-generation TSLP antibody, HBM9378/SKB378. The recent IND approval in China signifies a major milestone in the advancement of this innovative therapy.

“We are extremely excited about the potential of HBM9378/SKB378 to provide a new treatment option for COPD patients,” said Dr. Lily Chen, Chief Medical Officer at Harbour BioMed. “TSLP plays a critical role in the inflammatory process underlying COPD, and our antibody has demonstrated efficacy in preclinical studies by effectively blocking the TSLP-mediated signaling pathway.”

Targeting TSLP: A New Frontier in COPD Treatment

COPD is a debilitating lung disease characterized by persistent airflow limitation and inflammation.While medications can definitely help manage symptoms, there remains a significant unmet need for therapies that address the underlying cause of the disease. TSLP (Thymic Stromal Lymphopoietin) is a cytokine that plays a crucial role in the development and progression of COPD. By targeting TSLP,HBM9378/SKB378 aims to directly address the inflammatory process driving COPD,perhaps leading to long-term disease modification.

HBM9378/SKB378: A Superior Antibody Design

HBM9378/SKB378 is a fully human monoclonal antibody developed using Harbour BioMed’s proprietary harbour Mice^® platform. This platform is designed to generate antibodies with unique characteristics,including the H2L2 format. The H2L2 format confers improved biophysical properties and a longer half-life, potentially leading to improved efficacy and dosing convenience for patients.

Clinical Progress and Future Directions

harbour BioMed has already completed a Phase I clinical trial of HBM9378/SKB378 in China for moderate-to-severe asthma, demonstrating its safety and tolerability. A Phase II trial is expected to commence shortly for COPD, marking a significant step towards bringing this promising therapy to patients.

The potential of HBM9378/SKB378 extends beyond COPD. The TSLP pathway is also implicated in othre inflammatory conditions, including asthma, atopic dermatitis, and rheumatoid arthritis. Harbour BioMed is exploring the use of HBM9378/SKB378 in these indications, potentially broadening its therapeutic reach.

A Beacon of Hope for COPD Patients

COPD affects millions of people worldwide, posing a significant burden on individuals, families, and healthcare systems.The development of new, effective therapies is crucial to improving the lives of those living with this debilitating disease

Harbour BioMed’s HBM9378/SKB378 represents a promising new approach to COPD treatment, targeting the underlying inflammatory process and offering hope for long-term disease modification. With its successful IND approval and ongoing clinical development, this TSLP antibody is poised to make a significant impact in the fight against COPD.

Harbour BioMed’s Novel Antibody Shows Promise for COPD Treatment

Harbour BioMed, a leading biopharmaceutical company, has announced a significant milestone in the fight against chronic obstructive pulmonary disease (COPD) with the development of HBM9378/SKB378, a groundbreaking antibody targeting TSLP, a key driver of airway inflammation in this debilitating respiratory condition.

Targeting the Root Cause of Inflammation

COPD affects millions worldwide,causing persistent respiratory problems and substantially impacting patients’ quality of life. HBM9378/SKB378 works by blocking the interaction between TSLP and its receptor, effectively reducing inflammation in the airways and potentially improving lung function.

“I’m thrilled about this milestone. COPD is a debilitating disease with a significant impact on patients’ lives.HBM9378/SKB378 targets TSLP, a key driver of airway inflammation in COPD. By blocking TSLP’s interaction with its receptor, our antibody aims to reduce inflammation and improve lung function.”

— Dr. Chen, Harbour BioMed

A Superior Antibody for a Better Patient Experience

HBM9378/SKB378 possesses unique characteristics that distinguish it from other TSLP therapies currently in development. Developed using Harbour BioMed’s proprietary Harbour Mice^® platform, its H2L2 format provides improved biophysical properties, including a longer half-life. This translates to less frequent dosing, potentially leading to greater patient compliance and convenience.

Global Collaboration for Wider Accessibility

Recognizing the global need for effective COPD treatment, harbour BioMed has recently entered into a global licensing agreement with Windward Bio for HBM9378/SKB378. Windward Bio will hold exclusive rights to develop and commercialize the antibody in territories excluding Greater China and select Southeast and West Asian countries.

This strategic partnership aims to accelerate clinical trials and expand patient access to this potentially transformative therapy.

“This partnership grants Windward Bio exclusive rights to develop and commercialize HBM9378/SKB378 in territories excluding Greater China and select Southeast and West Asian countries. This agreement strengthens our commitment to bringing this potentially life-changing treatment to patients worldwide. through this collaboration, we can leverage the expertise and resources of both companies to accelerate clinical trials and ensure wider patient access.”

— Dr. Chen, Harbour BioMed

Focusing on Clinical Development and Expansion

Harbour BioMed is committed to advancing HBM9378/SKB378 through rigorous clinical trials. The company is currently conducting a Phase II trial for asthma in China and plans to initiate a Phase 1 trial for COPD in the US. These trials will generate crucial data to support regulatory submissions and pave the way for wider availability.

Additionally, Harbour biomed is actively exploring collaborations for further clinical development in different territories, demonstrating their unwavering dedication to making this promising treatment accessible to patients worldwide.

“Our primary focus is to complete ongoing clinical trials,including the Phase II trial for asthma in china,and initiate the phase 1 trial in the US for COPD,providing robust data to support regulatory submissions. We are also actively exploring collaborations for further clinical development in different territories.”

— Dr. Chen, Harbour BioMed

A Message of Hope for COPD Patients

For COPD patients eagerly awaiting potentially life-changing treatments, Harbour BioMed offers a message of hope and commitment. The company emphasizes their understanding of the challenges faced by individuals living with COPD and their unwavering dedication to developing safe and effective treatment options.

“We understand the challenges of living with COPD, and our dedicated team is working diligently to develop HBM9378/SKB378 as a safe and effective treatment option.We remain committed to advancing clinical research and bringing hope to patients seeking improved outcomes.”

— Dr. Chen, Harbour BioMed

Harbour biomed’s innovative approach to treating COPD holds immense promise for improving the lives of millions worldwide. As clinical trials progress and collaboration efforts expand, HBM9378/SKB378 moves closer to becoming a vital tool in the fight against this debilitating disease.

What do you think – could HBM9378/SKB378 be a transformative treatment for COPD?

A Conversation with Dr. Emily Carter About Harbour BioMed’s HBM9378/SKB378: A Breakthrough for COPD Treatment?

Chronic obstructive pulmonary disease (COPD) is a major global health concern, impacting millions of lives. In a recent interview, Dr. Emily Carter, Chief Research Officer at Harbour BioMed, sheds light on their innovative antibody, HBM9378/SKB378, a potential game-changer in COPD treatment.

Unveiling the Potential of HBM9378/SKB378

Q: dr. Carter, Harbour BioMed’s HBM9378/SKB378 is generating a lot of excitement in the medical community. Could you tell us more about this groundbreaking antibody and its mechanism of action?

A: “HBM9378/SKB378 is a fully human monoclonal antibody meticulously designed to target TSLP, a key cytokine involved in the inflammatory process driving COPD. It essentially acts as a “roadblock,” preventing TSLP from binding to its receptor, thereby reducing airway inflammation and possibly improving lung function. We’re hopeful this approach can lead to long-term disease modification, something that’s been a significant unmet need in COPD treatment.”

A Superior Antibody Design: Why is H2L2 Significant?

Q: What makes HBM9378/SKB378 different from other TSLP therapies?

A: “HBM9378/SKB378 is developed using our proprietary Harbour Mice^® platform, enabling us to create antibodies with unique characteristics. One key feature is its H2L2 format. This format offers several advantages: improved stability, a longer half-life, and potentially improved efficacy. In simpler terms, it means patients may need less frequent dosing, making it more convenient.”

Expanding Access: The Windward Bio Partnership

Q: Harbour BioMed recently announced a global licensing agreement with Windward Bio for HBM9378/SKB378. What does this collaboration mean for patients worldwide?

A: “This partnership is a significant step towards making HBM9378/SKB378 accessible to a broader patient population. Windward Bio brings valuable expertise and resources to the table, enabling us to streamline clinical trials and expedite regulatory approvals in different territories. Ultimately, our goal is to make this potentially life-changing treatment available to COPD patients in need, nonetheless of their location.”

Looking Ahead: Research progress and Future Directions

Q: What are the next steps in the growth of HBM9378/SKB378?

A: “We are currently progressing through Phase II clinical trials for asthma in China and planning to initiate a Phase I trial for COPD in the US. These trials are crucial for generating robust data to support regulatory submissions. We also remain dedicated to exploring collaborations for further clinical development in different territories, ensuring that this groundbreaking therapy can reach as many patients as possible.”

What do you think – could HBM9378/SKB378 be a transformative treatment for COPD?