Seven High-Profile Advances from HTGE’s Portfolio: BeiGene Biosciences, Viva Biotech, Xinkanghe Bio, Changfeng Pharma, Boan Bio, Henlius, and Fangzhou Jianke

Jan 07, 2025 14:45 CST Updated 14:45

Mabworks

Differentiated Antibody Drug Developer

VIVAVISION

Innovative Drug Developer

CF PharmTech

Full-series Product Developer for the Respiratory System

BoAn Biotech

Integrated Biopharmaceutical R&D and Manufacturing Company

Henlius

Innovative Biopharmaceutical Company

Fangzhou Pharmaceutical

Chronic Disease Service Platform

▲ The thirteenth issue of Gao特佳's industry research journal《Gao·Insights》has been officially released. The report《Sanming Medical Reform Takes New Steps: An In-depth Analysis of the Restructuring and Impact on China’s Healthcare System》comprehensively analyzes the practice of Sanming's medical reform and explores a Chinese-style healthcare security system.

Recently, Gao Tejia Invested in Multiple Members of the Medical EcosystemBeijing Mabworks Biotechnology Co.,Ltd, VIVAVISION, Xinkanghe, CF PharmTech,Shandong BoAn Biotechnology Co. Ltd.Shanghai Henlius Biotech, Inc., Fangzhou PharmaceuticalAchieved multiple clinical and commercialization advancements. As a long-term believer deeply committed to China's healthcare industry, Gao Tejia Investment firmly believes in the vast prospects of the healthcare and health industry.Will continue to explore innovative companies that truly meet clinical needs and values, and accompany more outstanding healthcare enterprises.The industry is growing rapidly.

01
Beijing Mabworks Biotechnology Co.,Ltd: Trispecific Antibody MBS314 (SC))
Clinical Trial Application Approved by U.S. FDA‍

Recently, Beijing Mabworks Biotechnology Co., Ltd. ("Mabworks") and Kangyuan Bochuang Biotechnology (Beijing) Co., Ltd. ("Kangyuan Bochuang") jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for their co-developed trispecific antibody MBS314(SC) (administered via subcutaneous injection) for Phase I clinical trials, intended for the treatment of relapsed/refractory multiple myeloma.‍‍

MBS314, as a novel mechanism-based trispecific antibody targeting CD3/BCMA/GPRC5D, features a differentiated CD3 binding epitope that enables low-affinity but sustained activation of T cells for killing effects, offering enhanced safety. Meanwhile, its high-affinity binding to BCMA and GPRC5D overcomes the heterogeneity issue of BCMA and GPRC5D expression in tumor cells within patients, effectively eradicating tumor lesions with improved broad-spectrum efficacy. Dr. Li Feng, Chairman and General Manager of Beijing Mabworks Biotechnology Co., Ltd., stated: "MBS314 (SCThe approval of Phase I clinical trial is an important milestone in the overall development of the company, and a critical step in the international clinical development strategy of MBS314. We look forward to it bringing greater benefits to patients with multiple myeloma.”

On November 6, 2024, Beijing Mabworks Biotechnology Co., Ltd., Kangyuan Bochuang, and Pfizer signed a "Memorandum of Cooperation" at the 7th China International Import Expo.Record". According to the "Memorandum of Cooperation", through Pfizer's Ignite program, all parties will jointly explore global clinical development opportunities for the MBS314 project in the treatment of multiple myeloma.

Beijing Mabworks Biotechnology Co., Ltd. focuses on the research and development and industrialization of innovative antibody-targeted drugs, committed to bringing novel therapeutic solutions to patients with autoimmune diseases and cancer. The company transforms scientific breakthroughs in immunology and biology into new antibody-targeted therapies, developing products and driving technological innovation for various markets of autoimmune diseases and cancers that have significant unmet medical needs and market potential.

02‍
VIVAVISION: VVN461 TreatmentAnterior Uveitis
China Phase 2 Clinical Study Meets Primary Endpoint

Recently, VIVAVISION announced that the company's independently developed First-in-classThe innovative non-steroidal anti-inflammatory eye drop VVN461 demonstrated excellent anti-inflammatory effects in this clinical trial, with both dosage groups showingPositive Control 1%Compared with prednisolone acetate ophthalmic solution, it achieved non-inferiority to the control in both primary and secondary efficacy endpoints with statistical significance.‍

Anterior uveitis is the most common type of uveitis, accounting for more than half of all patients. Currently, treatment options for anterior uveitis are very limited. First-line treatment drugs usually choose potent glucocorticoid eye drops, but long-term or repeated use can lead to adverse reactions such as increased intraocular pressure, increased risk of cataracts, delayed corneal epithelial repair, and wound healing.‍‍‍‍

VVN461: A Breakthrough Innovation in Ophthalmic Anti-Inflammatory Treatment‍‍‍‍‍‍‍‍‍‍‍‍

VIVAVISION is a clinical-stage innovative drug company focused on the field of ophthalmic treatment. The company was founded by a team of world-class experts in ophthalmic drug research and development and has established a unique platform for innovative ophthalmic drug research. Several self-developed innovative drug products have already entered or are about to enter the clinical stage.

03‍
Xinkanghe: XKH001 Moderate to Severe Atopic Dermatitis (AD)‍
Phase II Clinical Study Completes First Patient Dosing‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Zhejiang Xinkanghe Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as "Xinkanghe") announced that the first patient has been enrolled globally in the Phase II clinical trial of its self-developed First-in-class drug XKH001 injection (anti-IL-25 monoclonal antibody) for the treatment of moderate to severe atopic dermatitis (AD).

XKH001 is the world's first anti-IL-25 monoclonal antibody inhibitor independently designed and developed by Xinkanghe. It is the only IL-25 target drug in the world that has entered clinical trials, while other drugs with the same target are currently in the preclinical development stage. XKH001 for asthma indication has completed Phase Ia and Ib clinical trials in healthy Chinese subjects, as well as Phase Ic clinical trials in asthma patients.

XKH001 Injection for the Treatment of Moderate to Severe Atopic Dermatitis (AD) Receives Clinical Trial Approval from China's National Medical Products Administration (NMPA) on October 21 and from the U.S. Food and Drug Administration (FDA) on November 1. This marks the second indication for global clinical development following the approval of clinical trial applications in both China and the U.S. for the asthma indication. Xinkanghe will systematically proceed with subsequent clinical trial developments and expand its product pipeline to multiple indications. The company plans to apply for Phase II clinical trial permits for Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF) from regulatory authorities in the first quarter of 2025.

Xinkanghe was founded in 2015 by renowned international immunologist Academician Chen Dong. The company adheres to cutting-edge international immunology research as its foundation, focusing on the development of macromolecular drugs in the fields of autoimmune diseases and immuno-oncology. It is committed to creating innovative drugs with independent intellectual property rights originating from China and targeting the global market, providing patients with first-in-class or best-in-class therapeutic solutions.

04‍
CF PharmTech: ComfortFeimin®Allergic Rhinitis
Phase III Clinical Research ResultsPublished in an international authoritative journal

Recently, a "Nasal Spray of Azelastine and Fluticasone Propionate" study led by Professor Luo Zhang from Beijing Tongren Hospital, Capital Medical University, was conducted with the participation of 32 clinical institutions across China.The Phase III clinical research results of "(Shu Fei Min®) for the treatment of allergic rhinitis: Efficacy and Safety" were published in *Asia Pacific Allergy*, the official journal of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology. This international authoritative journal focuses on allergy research and has been indexed by SCIE.

This study is a multi-center, randomized, double-blind, parallel-group trial comparing Dymista® as a control to evaluate the efficacy and safety of CF PharmTech's Shufei Min® in treating patients with allergic rhinitis (AR). The data results of this clinical study indicate that Shufei Min® significantly improves nasal symptoms and quality of life in patients with moderate to severe AR, equivalent to Dymista® nasal spray, with good safety and tolerability. From the perspective of clinical practice, this study not only provides doctors with new medication strategies and guidance but also accumulates experience with azelastine fluticasone nasal spray.Evidence-Based Medicine Evidence for Nebulizers.

Sufenmin® is the first domestically produced compound preparation of nasal corticosteroid and antihistamine in China, suitable for patients aged 12 years and above with moderate to severe allergic rhinitis (AR). It delivers two first-line medications in a single spray, fundamentally improving patient compliance and treatment efficacy. Numerous studies have shown that the azelastine-fluticasone nasal spray can relieve nasal symptoms in patients with moderate to severe AR more quickly and effectively, enhance overall therapeutic outcomes, and maintain good safety. This marks another milestone in the treatment of allergic rhinitis since the introduction of intranasal corticosteroids (INCS).

CF PharmTech is committed to researching, producing, and selling various types of inhalation drugs that are safe, effective, and beneficial to the public. It has established a multi-formulation R&D pipeline covering inhalation aerosols, inhalation powders, inhalation liquid formulations, inhalation sprays, nasal sprays, and liposomes.

05‍
BoAn Biotechnology: Authorized Sinovac Biotech in Hong Kong and Macao, China‍
Exclusive Promotion of Denosumab Injection‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, BoAn Biotech(6955.HK) announced its collaboration with Sinovac Biotech on two denosumab injection products, BA6101 (Chinese trade name:Boyoubei^®) and BA1102 (Chinese trade name:Bolonga^®) to sign an agreement for commercial rights, granting the latter exclusive promotion of two products in the Hong Kong and Macao regions of China.

According to the agreement, Sinobioway Pharmaceutical will act as the Marketing Authorization Holder (MAH) responsible for the sales of the two products in Hong Kong and Macao, China. Shandong BoAn Biotechnology Co. Ltd. will be responsible for the commercial production and supply of the products, and will receive an upfront payment and milestone payments.

BA6101 and BA1102 are the original reference drugs of denosumab, Prolia® (widely used for osteoporosis) and Xgeva® (Biosimilars for the treatment of bone metastases from solid tumors, multiple myeloma, giant cell tumor of bone, and hypercalcemia. The two products were independently developed based on BoAn Biotechnology's global development strategy and are planned for commercialization in multiple countries and regions worldwide. The two products were approved for marketing by the China National Medical Products Administration in 2022 and 2024, respectively, and are currently in the international multicenter Phase III clinical trial stage in Europe, the United States, and Japan. After the completion of this clinical trial, Shandong BoAn Biotechnology Co. Ltd. will submit marketing applications for BA6101 and BA1102 to international pharmaceutical regulatory agencies such as the European Medicines Agency, the U.S. Food and Drug Administration, and Japan's Pharmaceuticals and Medical Devices Agency., apply for all indications of the original reference drug.

Shandong BoAn Biotechnology Co. Ltd. (6955.HK) is a fully integrated biopharmaceutical company dedicated to the development, manufacturing, and commercialization of biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic disorders. The company’s new drug discovery efforts are centered around multiple platforms, including a fully human antibody transgenic mouse and phage display technology platform, a bispecific T-cell engager technology platform, an antibody-drug conjugate (ADC) technology platform, and a cell therapy platform.

06‍
Shanghai Henlius Biotech, Inc.: HLX78International Multicenter Phase III Clinical Study
Completion of the First Patient Dosing in China

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Recently, Shanghai Henlius Biotech, Inc. (2696.HK) announced HLX78(Lasofoxifene, Lasofoxifene Tablets) in combination with Abemaciclib (CDK4/6 inhibitor) for the treatment of patients with locally advanced or metastatic breast cancer who are estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), have previously received aromatase inhibitor (AI) therapy, and have estrogen receptor alpha gene (ESR1) mutations – the international multicenter Phase III clinical study (ELAINE-3 study, NCT05696626) has completed the first patient dosing in China. Currently, the study is simultaneously recruiting subjects in the United States, Canada, the European Union, and other countries and regions.‍‍‍‍‍

HLX78 is an orally available selective estrogen receptor modulator (SERM) under clinical investigation, licensed by Shanghai Henlius Biotech, Inc. from Sermonix Pharmaceuticals, Inc. It demonstrates potent targeted therapeutic effects in the treatment of ESR1-mutated ER+/HER2- metastatic breast cancer. In two completed Phase II clinical studies (ELAINE-1 and ELAINE-2 trials), lasofoxifene exhibited anti-tumor activity both as a monotherapy and in combination with a CDK4/6 inhibitor against ESR1-mutated tumors. Based on lasofoxifene’s bioavailability and drug activity against estrogen receptor mutations, this candidate drug shows promise.Bring hope to the patient population with acquired ESR1 mutations after endocrine therapy and are expected to play a key role in the precision medicine treatment of advanced ER+ breast cancer.

Shanghai Henlius Biotech, Inc. (2696.HK) is an international innovative biopharmaceutical company dedicated to providing affordable high-quality biologics for patients worldwide. Its products cover areas such as oncology, autoimmune diseases, and ophthalmic conditions. To date, six of its products have been approved for marketing in China, three internationally, with 25 indications approved. Additionally, four marketing applications have been accepted by the Chinese NMPA, the U.S. FDA, and the European EMA.

07‍‍
Fangzhou Pharmaceutical: Strategic Cooperation with Bristol-Myers Squibb‍‍
Jointly Explore New Paths for the Innovative Development of Internet Healthcare‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Fangzhou Pharmaceutical (6086.HK) and Bristol-Myers Squibb China held a strategic cooperation signing ceremony in Shanghai. The two parties will conduct in-depth cooperation in the construction of digital medical platforms and the upgrading of Internet-based health management models, jointly exploring new paths for the innovative development of Internet healthcare.‍

Dr. Fangmin Xie, Founder, Chairman and CEO of Fangzhou Pharmaceutical, and Edward Man, Head of BMS China Innovative Medicines Division and General Manager of Hong Kong Market, signed a strategic cooperation agreement.

This strategic cooperation will focus on in-depth collaboration regarding the treatment drugs for β-thalassemia, Reblozyl®, and psoriasis treatment medication Sotyktu®, exploring innovative digital-intelligent marketing project management models. Notably, Reblozyl® has recently been successfully renewed in the National Medical Insurance Catalog, and its newly applied indication this year is expected to be approved by 2025; Sotyktu® has also been officially included in the National Medical Insurance Catalog this year, and starting from 2025, the disease burden for relevant patients is expected to be further reduced.

Fangzhou Pharmaceutical and Bristol-Myers Squibb Reach Strategic Cooperation: A Deep Exploration and Reshaping of Internet Healthcare Management Models, and a Vivid Practice in Jointly Safeguarding Public Health. Looking ahead, Fangzhou Pharmaceutical will move forward hand-in-hand with Bristol-Myers Squibb, leveraging their respective strengths in digital innovation, comprehensive channel cooperation, and chronic disease management services to form a powerful synergy, contributing to the healthy future of China's internet healthcare industry.

About Gortec 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 led by strategic equity investments and covers all investment stages, including VC, PE, Pre-IPO, and M&A. With a professional investment team that deeply focuses on the healthcare track, it builds an investment ecosystem platform for the healthcare industry and aims to become a healthcare investment institution with global influence.

Gortka Investment's asset management scale exceeds 22 billion RMB, with 35 healthcare industry funds. It has invested in over 110 healthcare companies and facilitated the successful listing of 37 enterprises, including Mindray Medical, United Imaging Healthcare, and Akeso Biopharma. Gortka Investment operates in China and globally, with operational centers in Shenzhen, Shanghai, Beijing, Hong Kong, and other locations. It is committed to investing in outstanding healthcare companies worldwide, creating new development opportunities for global capital and medical enterprises, and assisting entrepreneurs in building great companies.