Chengdu Hyperway Pharmaceuticals Co., Ltd. (hereinafter referred to as “Hyperway”) has officially applied for clinical study on the first small molecule original new drug.

 

       The drug is a third generation of anti-drug-resistant and reversible BTK inhibitor with a new structure which is independently developed by Hyperway. It will be used to treat tumors including lymphoma and leukemia as well as autoimmune diseases like kidney disease, urticaria, lupus erythematosus, multiple sclerosis and rheumatoid arthritis. The drug has a wide range of application markets and development prospects.

 

 

       From project approval in May 2019 to present clinical application, it took only 2 years for Hyperway to realize the breakthrough of clinical application for original new drug from “0” to “1”. This is the first deliverable of Hyperway and also the first major milestone of Hyperway to “manufacture good domestic drugs”.

 

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       Bruton tyrosine kinase (BTK) inhibitor

 

       BTK inhibitors have achieved a great success in the treatment of lymphoma and leukemia. At present, the sales market of BTK inhibitors has exceeded USD 10 billion in the tumor field. Coupled with the application of BTK inhibitors in the treatment of multiple autoimmune diseases, it is expected that its market scale will exceed USD 50 million by 2030.

 

       However, the 5 types of BTK inhibitors marketed are all reversible inhibitors. Due to C481S mutation and other reasons, drug resistance will be produced after taking the inhibitors, and the five-year drug resistance rate is as high as 80%, seriously inhibiting the application of BTK inhibitors in the treatment of autoimmune diseases. Therefore, the development of anti-drug-resistant and reversible BTK inhibitors is not only an urgent clinical requirement for patients with B-cell tumors, but also can provide a new treatment option for patients with autoimmune diseases.

 

 

       There are still no anti-drug-resistant and reversible BTK inhibitors approved for marketing. MSD ARQ-531 in clinical Phase II, Lilly LOXO-305 in clinical Phase III and two domestic BTK inhibitors in clinical Phase I have achieved the fastest research progress. But due to efficacy, pharmacokinetics or safety problem, the indications developed are all in the tumor field, and autoimmune diseases are not involved.

 

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       Third generation of anti-drug-resistant and reversible BTK inhibitors

 

       For the third generation of anti-drug-resistant and reversible BTK inhibitor with a new structure and independent intellectual property right which is independently developed by Hyperway, key pre-clinical head-to-head comparative data such as safety (dozens of times of high security window) and efficacy are better than those of ibrutinib, ARQ-531 and LOXO-305. In addition to the application in the treatment of lymphoma and leukemia, the BTK inhibitors may be more preponderant in the treatment of autoimmune diseases like kidney disease, urticaria, sjogren syndrome, lupus erythematosus, asthma, multiple sclerosis and rheumatoid arthritis.

 

 

       About Hyperway

       Adhering to the corporate concept of "manufacturing efficient drugs and benefiting the people all over the world”, Hyperway is developing better-quality and cheaper new medicines, and continues to explore. Over the two years, Hyperway has developed multiple original new drug R&D projects quickly and efficiently, and determined 6 PCCs, of which 1 has been applied for Phase I clinical trial and 3 are being applied for all-round IND study.

 

       Next, Hyperway will build three drug R&D centers around platform technologies to drive the further rapid development of original new drugs, including Chengdu New Drug R&D Center based on the platform of new-generation nucleic acid drug development and oral peptide drug delivery, American R&D Center which is drive by AI, based on the platform of protein degradation technology (including molecular glue) and developed for traditional undruggable targets, and Shenzhen New Drug R&D Center for Brain Diseases based on the platform of strong brain drug development. The three centers strive to build Hyperway a new international bio-pharmaceutical enterprise with leading concept, strategy and technology as soon as possible.

 

 

       On the online sub-forum of “the Sixth (2021) Futang Pediatric Development Conference” sponsored by Futang Research Center of Pediatric Development and undertaken by West China Second University Hospital, Sichuan University, Dr. Zhu Yi, President of Baili Pharm was invited to attend the sub-forum and gave a special report on innovation, research and development of Children's medicines from the perspective of industry-university-research cooperation.

 

 

       Dr. Zhu Yi shared that, Baili Pharm has constructed an internationally leading complete core technology platform for antibody drug development from antibody discovery to CMC, and core molecule platforms including SEBA bisspecific antibody, GNC multispecific antibody, GNC-T cell therapy and SHRI-ADC drugs.

 

       In the coming 3 years, not only 7 ADC drugs related to pediatric tumors but also 7 GNC multispecific antibody drugs related to pediatric tumors will enter the clinical study successively. We expect a real breakthrough effect for the treatment of children's tumors.

 

 

       On the existing drug development platforms related to children's common diseases, Baili was actively cooperating with multiple scientific research platforms and institutions centered by Beijing Children's Hospital in 8 major new pediatric drug development projects during the period of the 13th Five-Year Plan. Although clinical research on children's medicines is indeed faced with many challenges, we believe that under the support of Futang Research Center of Pediatric Development, we will bring better treatment means for common pediatric diseases sooner.

 

       Recently, Baili will launch a multi-center clinical study on a drug (guanfacine hydrochloride) for the treatment of attention deficit and hyperactivity disorder in children. I sincerely hope to invite the major clinical research centers for children's drugs in China to participate.

 

       Baili always adheres to “penetrating the cognitive frontier with scientific logic”, and conducts breakthrough innovation for breakthrough efficacy. In terms of children's medicine development we will comply with the unique requirements and opportunities of children's medicine development, promote the active cooperation and contribute to the innovative development of children's medicines in China.

 

       About Baili Pharm

       Baili Pharmaceutical is a bio-pharmaceutical enterprise which focuses on global bio-pharmaceutical frontier field and is based on solving clinical unmet requirements. The Company has the drug research and development capability including small molecule chemical drugs, large molecule biological drugs and ADC drugs, has the integration advantage of from intermediates, APIs to preparations, and has the commercial operation capability covering the complete life cycle of “R&D - production - marketing”.

 

       The Company has 2 new drug R&D centers (SYSTIMMUNE in Seattle and BAILI PHARM/ BAILI-BIO located in Phase I of Tianfu Life Science Park), 1 antibody and ADC drug manufacturer, 1 chemical intermediate production enterprise, 1 chemical API manufacturer, 2 chemical pharmaceutical preparation manufacturers and 2 marketing companies.

 

 

Source: Chengdu Hyperway Pharmaceuticals Co., Ltd., Baili Pharm