Seven Companies in GenTrust Healthcare Ecosystem — DK Medical, TG Therapeutics China, PuraCure, Zhonghui Bio, Boan Biologics, Henlius, and Medcaptain — Achieve Key Clinical and Commercial Milestones

Oct 25, 2024 14:30 CST Updated 14:30

DK Medtech

Vascular Interventional Balloon Product Developer

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Recently, highTEJIA Investment's Medical Ecosystem Includes Multiple Members: DK Medtech, Tian Guangshi Biotech, PreceRef Biostatistics, Zhonghui Biotech, Boan Biotech, Henlius, and Micromed Technology.Achieved multiple clinical and commercial advancements. As a long-term believer deeply engaged in China's healthcare industry, GaoTJ Investment firmly believes in the vast prospects of the healthcare sector. It will continue to seek out truly innovative companies with clinical needs and value, supporting more Chinese healthcare enterprises to grow rapidly.

01
DK Medtech:DKutting™ LL
Peripheral Scoring Balloon Dilation Catheter Approved for Marketing

Recently,DK Medical Technology Co., Ltd. (hereinafter referred to as "DK Medtech") announced that its self-developed DKutting™ LL Peripheral Scoring Balloon Dilation Catheter has officially received approval from the National Medical Products Administration for market launch (Registration Certificate No.: 20243031906).

DKutting™ LL adopts DK Medtech's unique patented triangular nitinol coil technology, combined with the actual clinical needs of lower limb arteries. It significantly increases the length of the scoring element (up to 150mm) and develops a new fully coaxial balloon delivery system compatible with 0.014”/0.018” guidewires, while enriching the selection of balloon diameters at 0.5mm intervals.

DK Medtech's exclusive directional scoring balloon boasts comprehensive performance with robust radial expansion and flexible axial bending. Its clinical performance has been widely recognized in both the coronary and hemodialysis access fields. The newly developed DKutting™ LL scoring balloon is specifically designed for lower limb arterial intervention, demonstrating significant clinical advantages in directional expansion mechanisms and setting a new standard for peripheral vascular pre-dilation.

DK Medtech has become a leading innovator in China for a full range of interventional balloon products. It has developed more than ten types of balloons, including standard balloons, high-pressure balloons, scoring balloons, and drug-coated scoring balloons. Its product line covers the needs of almost all vascular intervention fields, including cardiovascular, peripheral, and neurovascular interventions. By utilizing its self-developed directional scoring technology, which is applied in coronary scoring balloons, peripheral scoring balloons, and drug-coated scoring balloons, DK Medtech’s products have demonstrated significantly better clinical benefits compared to imported control groups in pre-market RCT studies. The company has achieved outstanding results and market position in niche markets and has signed multiple strategic cooperation agreements with well-known foreign enterprises such as Medtronic and Asahi Intecc.

02‍
Tian Guangshi: At the CSN Annual Academic Conference for Two Consecutive Years
Report on MIL62 Treatment for Primary Membranous Nephropathy Research Data‍‍

Recently, Beijing Tian Guang Shi Biotechnology Co., Ltd. (hereinafter referred to as "Tian Guang Shi") announced thatDuring the 2024 Annual Academic Conference of the Chinese Society of Nephrology (CSN), updated data from the ongoing Phase Ib/II clinical study on the third-generation CD20 antibody MIL62 for the treatment of primary membranous nephropathy was presented in an oral report. The study includes a minimum follow-up period of 76 weeks. This clinical research data was presented by Professor Cui Zhao from Peking University First Hospital.。

As the third-generation CD20 antibody, MIL62 demonstrates stronger ADCC activity and the ability to eliminate abnormally activated B cells in the body. The latest one-and-a-half-year (76-week) follow-up data released this time shows that MIL62 is sustainably and significantly superior to calcineurin inhibitors and the first-generation CD20 antibody rituximab in terms of safety, efficacy, renal function protection, and compliance. This extends the clinical advantages previously reported in the one-year (52-week) follow-up data presented at the 2023 CSN Annual Meeting and the six-month (24-week) follow-up data presented at the 2023 European Renal Association (ERA) Congress.

MIL62 is an innovative third-generation CD20 recombinant humanized monoclonal antibody independently developed by Tian Guangshi. The product was developed based on the company's self-innovated ADCC-enhanced antibody platform and has received support from the National Major New Drug Innovation Project. The Phase III clinical trial of MIL62 for the treatment of primary membranous nephropathy completed the planned enrollment of all subjects in November 2023 and has now entered the late follow-up stage, with the potential to be the first to meet the unmet clinical needs of Chinese patients with primary membranous nephropathy.

03‍
Precegen: Generative AI Tool ProT-Diff
Successfully Designed Novel Antimicrobial Peptides in Collaboration with CAS‍‍‍‍

Recently, Precision Scientific Technology (Beijing) Co., Ltd. ("Precision Scientific" for short) collaborated with Zhang Xian'en from the Institute of Biophysics, Chinese Academy of Sciences/Shenzhen Institute of Technology, and Wang Dianbing's research group from the Institute of Biophysics, Chinese Academy of Sciences to publish a research paper in the internationally renowned journal Advanced Science. Precision Scientific's newly developed modular generative AI tool, ProT-Diff, was used in this study for the design of novel antimicrobial peptides.

Through ProT-Diff, the research team successfully created multiple non-naturally occurring antimicrobial peptide drug candidate molecules with broad-spectrum antibacterial activity and good safety. In addition, the research team also validated the antibacterial effects and safety of these candidate molecules in both in vitro and in vivo environments. ProT-Diff integrates protein language models with diffusion models, significantly reducing the need for data training and computational resources; it enables the de novo design of various functional peptides quickly without requiring prior knowledge such as structural biology.This study confirms that Precise ProT-Diff has significant application value in the de novo design of functional peptides.

ProT-Diff can be applied to the design of various functional peptides (not only antimicrobial peptides) and the customization of special proteins; this algorithm can also be used for the design and generation of other types of functional sequences (DNA, RNA). The algorithm has been patented and authorized.Precision Medicine is a new platform company driven by "multi-omics + data mining," focusing on differentiated R&D strategies for innovative drugs., providing innovative services such as drug mechanism research, biomarker development, clinical differentiation strategies for drug development based on biomarkers and precision medicine, clinical statistics, central laboratory services, and co-development of drug companion diagnostics to pharmaceutical and biotech companies with globally leading standards.

04‍
ZH Bio: Trivalent Influenza Virus Subunit Vaccine‍‍
Listing Application Accepted‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

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Recently, Jiangsu Zhonghui Yuan Tong Biotechnology Co., Ltd. (hereinafter referred to as "Zhonghui Biotech")The marketing applications for "Trivalent Influenza Virus Subunit Vaccine for 6-35 Months of Age" and "Trivalent Influenza Virus Subunit Vaccine for Aged 3 Years and Above" have both been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. This acceptance marks that the first full-dose trivalent influenza virus subunit vaccine in China, applicable to individuals aged 6 months and above, will enter the final sprint stage, with its market launch imminent.

ZH BioTech has been deeply engaged in the field of subunit influenza technology. To date, ZH BioTech's subunit influenza vaccine portfolio includes: quadrivalent influenza virus subunit vaccine for individuals aged 6-35 months, quadrivalent influenza virus subunit vaccine for individuals aged 3 years and above, adjuvanted quadrivalent influenza virus subunit vaccine for the elderly, trivalent influenza virus subunit vaccine for individuals aged 6 months and above, adjuvanted trivalent influenza virus subunit vaccine for the elderly, as well as a universal subunit influenza vaccine currently under research and development.

This time, Zhonghui Biotech has completed the marketing application for a full-dose trivalent influenza virus subunit vaccine for people aged 6 months and above. This vaccine is the first trivalent influenza virus subunit vaccine in China to unify the dosage form for those aged 6 months and above, enhancing the convenience of influenza vaccination.

05‍‍
Boan Biotech: Nivolumab Injection Phase I‍‍‍‍
Publication of Clinical Pharmacokinetic Comparative Study Results‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, the Phase I clinical pharmacokinetic comparability study results of Nivolumab Injection (BA1104, formerly project number: LY01015), independently developed by Boan Biotech (6955.HK), were published in the international journal *BioDrugs*. This marks the world's first disclosed Phase I clinical pharmacokinetic similarity results for a biosimilar of Opdivo®.

Nivolumab is a humanized monoclonal immunoglobulin IgG4 antibody targeting the cell surface programmed death-1 (PD-1) receptor. By relieving the immunosuppression of immune cells by tumor cells, it restores the body's immune response, exerts an anti-tumor effect, and extends the patient’s life cycle. As a representative, tumor immunotherapy has become one of the main methods of cancer treatment globally, continuously demonstrating broad clinical application value. Research results indicate that the AUC0-∞, AUC0-t, and Cmax values between BA1104 and Opdivo® meet equivalence standards, suggesting similar pharmacokinetic profiles. Additionally, their safety and immunogenicity are also highly similar.

The development progress of BA1104 is internationally leading as the world's first biosimilar of Opdivo® to initiate a Phase III clinical trial, with the Phase III clinical study currently proceeding in an orderly manner. After completing the Phase III clinical trial, BA1104 can apply for simultaneous approval of all Opdivo® indications, including more than ten types of cancers such as non-small cell lung cancer, squamous cell carcinoma of the head and neck, gastric or gastroesophageal junction adenocarcinoma, malignant pleural mesothelioma, and urothelial carcinoma.

06‍
Fuhong Hanlin: HLX22 International Multicenter Phase III
Clinical Trial Approved in Japan‍

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Recently,Henlius Receives Approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to Initiate International Multicenter Phase III Study of its Innovative Anti-HER2 Monoclonal Antibody HLX22, Intended for First-Line Treatment of HER2-Positive Advanced Gastric Cancer in Combination with Trastuzumab and Chemotherapy.

Previously, the Investigational New Drug (IND) application for this study has been approved by the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA). Currently, there is no HER2 dual-targeting therapy for the treatment of HER2-positive gastric cancer that has been approved for marketing globally.

HLX22 is an innovative monoclonal antibody targeting HER2 that was licensed from AbClon, Inc. by Henlius and subsequently independently developed. Similar to trastuzumab, HLX22 binds to subdomain IV of HER2, but its binding epitope differs from that of trastuzumab, allowing both HLX22 and trastuzumab to simultaneously bind to HER2, thereby producing a stronger HER2 receptor blockade. Preclinical studies have shown that combination therapy with HLX22 and trastuzumab can inhibit EGF (epidermal growth factor) and HRG1 (Histidine-Rich Glycoprotein 1)-induced cell proliferation, enhancing anti-tumor activity both in vitro and in vivo.

07‍
McCloud Medical: New Product for Thrombosis Prevention and Control Launched‍‍‍‍
Integrated Platform Empowers Comprehensive VTE Management in Hospitals‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Shenzhen Medcaptain Biomedical Technology Co., Ltd. ("Medcaptain Medical" for short), as the designated partner of the Chinese VTE In-hospital Warning and Care Alliance, has collaborated with multiple Class III Grade A hospitals to promote the prevention of deep vein thrombosis (DVT) and launched a series of new products.

The Intermittent Pulsed Compression Anti-thrombosis System involves the main unit cyclically inflating and deflating airbags to intermittently apply pressure to the limbs encased in the airbags. This process passively contracts the muscles of the compressed limbs, thereby promoting venous blood return and preventing deep vein thrombosis. The 0.5S pulsed compression increases instantaneous blood return velocity, activates the endogenous fibrinolytic system, and prevents blood coagulation.

The main unit of the air pressure therapy device is compact and lightweight, with a large touch screen for easy and quick observation and use. It comes standard with a bedside hook and can also be paired with a trolley for convenient installation and transfer. The air pressure therapy device features venous filling detection technology that periodically checks vascular filling conditions and automatically adjusts venous refilling time in a personalized and dynamic manner. It includes a treatment scheduling function to arrange patient treatment times efficiently and a parallel function that supports simultaneous treatment of all four limbs.

The Integrated Thrombosis Prevention and Control Platform meets the Level 4 requirements of the China Pulmonary Embolism and Deep Vein Thrombosis Prevention and Treatment Capacity Building Project's Informationization Application and Quality Control Management Guidelines (2020 Edition), achieving intelligent application management in the VTE prevention and treatment process. From thrombus-related factor testing, mechanical thrombosis prevention to integrated VTE prevention and control management, Maikotian is committed to providing comprehensive solutions for in-hospital thrombosis prevention.

About Gortca Investment

GaoTJ Investment was founded in Shenzhen in 2001. It was the first in the industry to propose the investment model of "thematic industry investment," focusing on healthcare industry investments. It is primarily led by strategic equity investments, covering all stages including mergers and acquisitions, PE, VC, and angel investments. With one of the few professional investment teams in China deeply focused on the healthcare sector, it has built an investment ecosystem platform for the healthcare industry and aims to become a globally influential healthcare investment institution.

With assets under management exceeding 20 billion yuan, 35 healthcare industry funds, and over 170 invested companies, of which more than 110 are healthcare enterprises. Gortica's investment business is rooted in China and oriented towards the globe, with operational centers established in Shenzhen, Shanghai, Beijing, Hong Kong, and other locations. It is committed to investing in outstanding healthcare companies worldwide, bridging global capital with Chinese momentum for medical enterprises, and assisting entrepreneurs in building great companies.