Seven High-Profile Advances from CGEB's Portfolio Companies: Steady Progress in Clinical and Commercial Milestones

Nov 19, 2025 11:22 CST Updated 11:22

ICT

Oncology Drug Developer

Mabworks

Differentiated Antibody Drug Developer

Lyell Immunopharma

Cell Therapy New Drug Developer

▲ The 16th issue of Gao Tejia's industry research journal, *Gao·Insights*, is about to be released. The core research report focuses on in vivo CAR-T (in vivo CAR-T), which has the potential to shorten treatment cycles, reduce treatment costs, and improve treatment accessibility by directly editing genes in T cells within the body. Stay tuned.

Recently, members of the Gao特佳 (Gortka) healthcare ecosystem, including ICT, Mabworks, Zhonghui Biotech, Boan Biotech, VivaVision Biotech, United Imaging Intelligence, and Henlius, have achieved multiple clinical and commercial milestones. As a long-term investor dedicated to China's healthcare industry, Gao特佳 (Gortka) Investment remains confident in the vast potential of the healthcare sector and will continue to identify innovative enterprises that truly meet clinical needs and deliver value, supporting the rapid growth of more outstanding healthcare companies.

01
ICT: GCC19CART Achieves Overseas Licensing‍‍‍‍‍‍
Total transaction amount exceeds $8.6 billion‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, ICT, a clinical-stage biotechnology company focused on solid tumor CAR-T therapies, announced a collaboration with Lyell Immunopharma.ImmunopharmaICT Successfully Reached an Overseas Licensing Collaboration for Its Core Product GCC19CART, with a Total Transaction Value Exceeding $860 Million. This Not Only Sets a New High in the Field of CAR-T for Solid Tumors in China, but Also Marks the Formal Recognition by the Global Market of Cell Therapy Technology Independently Developed in China.‍‍‍

As the leading product developed by ICT based on its proprietary CoupledCAR® platform technology，GCC19CART Demonstrates Unprecedented Antitumor Activity in Third-Line and Above Treatment Settings for Relapsed/Refractory Metastatic Colorectal Cancer (R/RmCRC). In August 2025, ICT announced the successful completion of the dose-escalation phase of its U.S. Phase I clinical trial. Data showed that among 12 subjects, 54.5% achieved objective response (ORR), with the high-dose group (2×10^6 CAR-T cells/kg) reaching an ORR as high as 80%, and the median duration of response (mDoR) was 6.9 months.This efficacy data far exceeds the current third-line standard therapy approved by the U.S. FDA. With its excellent clinical performance, GCC19CART has received clinical trial approval and Fast Track designation from the U.S. FDA.

Under the license agreement, Lyell will obtain exclusive global rights to GCC19CART outside mainland China, Hong Kong, Macao, and Taiwan for research, development, manufacturing, and commercialization. ICT will receive a $40 million upfront payment and 1.9 million shares of Lyell common stock. ICT is also eligible for additional cash and equity consideration, as well as tiered royalties on future net sales. The additional cash consideration includes potential clinical milestone payments of up to $30 million, late-stage regulatory milestone payments of up to $115 million, and commercial sales milestone payments of up to $675 million.

02
Beijing Mabworks Biotechnology Co.,Ltd: Phase III Clinical Trial Results of MIL62 for Membranous Nephropathy Released‍‍‍‍
The world's first PMN Phase III clinical study to achieve its primary endpoint‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Beijing Mabworks Biotechnology Co.,Ltd announced that during the 58th Annual Meeting of the American Society of Nephrology (ASN) in 2025, the Phase III clinical research results of the third-generation CD20 antibody MIL62 for the treatment of primary membranous nephropathy (PMN) will be presented as an oral report at the "High-Impact Clinical Trials" session.. This clinical trial is the world's first Phase III PMN study to reach its primary endpoint, providing prospective randomized controlled clinical evidence for the global treatment practice of this disease.‍‍‍

In terms of clinical complete response, immunological complete response, and clinical response indicators, MIL62 monotherapy demonstrated deeper and more sustained responses compared to guideline-recommended treatments and other investigational drugs with published data. Not only did the primary endpoint, the 76-week clinical complete response rate, achieve statistically significant superiority, but it also exhibited breakthrough clinical value. In improving patients' renal function, the MIL62 monotherapy group showed significantly better glomerular filtration rate (eGFR mean change) at week 2 compared to the control group, with an upward trend beginning to emerge.

As of now, no specific drug for the treatment of PMN indications has been approved by pharmaceutical regulatory agencies worldwide, representing a significant unmet medical need for patients. MIL62 is currently the only drug under NDA review for this indication.The NDA application for MIL62, a new drug for PMN treatment, was accepted by the Chinese regulatory authority in September 2025 and included in the "Priority Review and Approval" list. It is expected to become the first drug approved in China for PMN treatment, offering patients suffering from the disease a new therapeutic option and hope for recovery.

Professor Cui Zhao Gives Oral Presentation on PMN at ASN Annual MeetingPhase III Clinical Research Results

03
Zhonghui Biotech: Trivalent, Tetravalent Influenza Virus Subunit‍‍‍‍
Vaccine (Adjuvant) Enters Phase I Clinical Trial as Scheduled‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Zhonghui Bio (2627.HK) and its subsidiary Yihui Bio jointly declared two Class I new drugs, the "Influenza Virus Subunit Vaccine (Adjuvanted)" and the "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvanted)," with Phase I clinical trials successfully initiated one after another in Hubei. The research and development achievements of these two vaccines are steadily translating into company performance, also marking a solid step forward for the company’s subunit influenza vaccine product pipeline towards providing the most precise coverage for different age groups and populations with varying needs.‍‍‍

The adjuvanted influenza subunit vaccine, developed by Zhonghui Biotech in response to the vaccination needs of different populations and WHO's recommendations for influenza vaccines, utilizes the company’s mature platform technology and a novel adjuvant. This vaccine is specifically designed for individuals aged 65 years and older. Preclinical studies have shown that the adjuvanted influenza subunit vaccine significantly enhances antibody levels and neutralizing antibody titers, demonstrating a marked advantage in boosting immune responses, offering the optimal choice for elderly populations in combating influenza.

In September 2025, Zhonghui Biotech Huier Kangxin®Approved for expanded use to include individuals aged 6 months and above, it has become the first and only quadrivalent influenza subunit vaccine in China approved for full-dose use across all age groups.This high-quality vaccine, which combines the characteristics of high purity, low adverse reactions, good safety, and superior immune effects, conforms to the international vaccine development trend. It unifies the vaccination dosage form for people aged 6 months and above, greatly enhancing the convenience of vaccination and management, and provides broader and more efficient immune protection for influenza prevention and control in China.

04
Boan Biotech: Two Self-Developed Denosumab Products
UK Marketing Authorization Application Accepted‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Boan Biotech (6955.HK) announced its self-developed denosumab injection 60 in the field of orthopedics.The UK marketing authorization applications for mg (BA6101) and denosumab injection 120mg (BA1102) in the field of oncology have recently been accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).‍‍‍

BA6101 is a biosimilar of Prolia® (Chinese trade name: 普罗力®). It was approved for marketing in China in 2022 as the first domestically produced denosumab injection (Chinese trade name: 博优倍®) and has received positive feedback from doctors and patients in nearly three years of clinical use. BA1102 is a biosimilar of Xgeva® (Chinese trade name: 安加维®) and was approved for marketing in China in 2024 (Chinese trade name: 博洛加®).

The marketing application in the UK represents an important milestone in Bio-Thera's internationalization process. As core products developed under Bio-Thera’s global development strategy, it is expected that BA6101 and BA1102 will be approved for all indications granted to the reference drugs in the UK. The UK will also become the first stop for these two products to serve patients internationally.In addition to the UK, marketing authorization applications for these two products will also be submitted to international pharmaceutical regulatory agencies such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

05
Vivoryon Biosciences: Clinical Trial Results of VVN461 Eye Drops in China and the US
Selected for Oral Presentation at the 129th Annual Meeting of the American Academy of Ophthalmology‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, the 129th annual meeting of the American Academy of Ophthalmology (AAO) was grandly held in Orlando. As one of the largest and most influential ophthalmic academic conferences globally, VivaVision Biotech presented the clinical trial results of VVN461 eye drops from both China and the United States in an oral presentation at the conference, receiving recognition from attending experts.Positive evaluation,The relevant findings were published in the international top-tier ophthalmology journal "Ophthalmology".。‍‍‍

At the conference, Professor Yang Liu, Director of the Ophthalmology Center at Peking University First Hospital and Chief Physician, serving as the principal investigator (PI) for VivaVision Bio's VVN461 eye drop Phase II clinical study in China, delivered an oral presentation on [Phase 2 Study of The Efficacy and Safety of VVN461 Solution in Patients with Noninfectious Anterior Uveitis]. Later, Dr. Gary Novack, an advisor to VivaVision Bio’s Scientific Advisory Board, presented orally during the "Poster Theatre" session on [A JAK Inhibitor for Post-operative Inflammation], systematically introducing the results of VivaVision Bio's core pipeline product, VVN461 eye drops, from its U.S. Phase II clinical trial. These presentations sparked significant interest and lively discussions among attendees and judges, who gave high praise for the impressive clinical trial outcomes.

VVN461 is a non-hormonal targeted anti-inflammatory innovative drug independently developed by VivaVision Bio, marking the world's first breakthrough innovation in applying JAK inhibitors to the field of ophthalmic anti-inflammation. It is a fourth-generation small-molecule inhibitor with high activity and high selectivity, targeting both JAK1 and TYK2.VVN461 Could Become the First Drug to Replace Hormonal Treatment for Uveitis; China's Center for Drug Evaluation of the National Medical Products Administration Has Granted VVN461 Breakthrough Therapy Designation.

Professor Yang Liu, Principal Investigator of the VVN461 Eye Drops Phase II Clinical Study in China, Delivers a Report

Dr. Gary Novack, Advisor to the VivaVision Biosciences Scientific Advisory Board, Delivers a Report

06
United Imaging Intelligence: Bone Age, Liver AI Applications Officially Approved
National Medical Products Administration Class III Medical Device Registration Certificate‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, two products of United Imaging Intelligence — the Bone Age Assessment Software for Pediatric Hand X-ray Images and the CT Image Triage Software for Focal Liver Lesions — have officially received Class III medical device registration certificates from China's National Medical Products Administration (NMPA). Since 2025, United Imaging Intelligence has obtained five additional Class III certificates, bringing the total number of Class III certificates to 17, placing it among the industry leaders.‍‍‍

United Imaging Intelligence's Pediatric Hand X-ray Bone Age Assessment Software can automatically detect ossification centers based on wrist X-ray images of children aged 0.5 to 18, using a modern Chinese pediatric bone age atlas. It assists in evaluating TW3C-RUS and TW3C-Carpal bone age while providing height prediction results using three methods. This not only significantly reduces the time doctors spend reviewing images but also improves the accuracy of ossification center grading and bone age calculation, offering robust support for assessing children's growth and development as well as clinical decision-making. United Imaging Intelligence's Liver Focal Lesion CT Image Triage Assistance Software intelligently processes, measures, and analyzes liver CT images, assisting in triaging focal liver lesions such as hepatocellular carcinoma, cysts, hemangiomas, etc., effectively enhancing diagnostic efficiency.

Since the beginning of this year, United Imaging Intelligence has made significant progress in both domestic and international markets. A total of 17 AI applications have been approved for NMPA Class III certification, 31 AI applications have received EU CE certification (the largest number of AI application certifications globally), and 15 AI applications have been approved by the U.S. FDA.United Imaging Intelligence is redefining the future of digital and intelligent healthcare, accelerating its progress toward becoming a world-class innovator in digital and intelligent medical solutions.

07
Henlius: The First Pertuzumab Biosimilar in the U.S.
POHERDY® Approved by the U.S. FDA‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Henlius (2696.HK) and Organon jointly announced the Pertuzumab Injection(420mg/14mL) POHERDY® (pertuzumab-dpzb) Biologics License Application (BLA) approved by the U.S. Food and Drug Administration (FDA) and interchangeable with the reference product PERJETA (pertuzumab), becoming the first and only PERJETA biosimilar in the United States.Covering all its approved indications in the United States。‍‍‍

Pertuzumab is a monoclonal antibody targeting the HER2 receptor and an essential component in the treatment of HER2-positive breast cancer. It is indicated for: metastatic breast cancer, used in combination with trastuzumab and docetaxel to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease; and early-stage breast cancer.

This FDA approval is primarily based on the review of a comprehensive data package, including analytical similarity studies, clinical pharmacokinetic studies, and clinical comparative studies.Studies show that POHERDY® is highly similar to the original product PERJETA in terms of safety, purity, and potency (i.e., safety and efficacy) and can be used interchangeably.In 2022, Henlius entered into a licensing and supply agreement with Organon, granting Organon exclusive commercial rights to several biosimilars, including POHERDY®, in global regions outside of China. The approval of POHERDY® in the United States will further expand the oncology portfolios of both parties and help bring high-quality biologics to more patients.

About Gao Te Jia Investment

GaoTeJia Investment was founded in Shenzhen in 2001, being 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 mergers and acquisitions. It has a professional investment team that is among the few in China deeply focused on the healthcare track, building an investment ecosystem platform for the healthcare industry. It aims to become a healthcare investment institution with global influence.

Gortec Investment's asset management scale exceeds 23 billion RMB, with 35 healthcare industry funds. It has invested in over 110 healthcare enterprises and facilitated the successful listing of 41 companies, including Mindray Medical, United Imaging Healthcare, and Akeso Biopharma. Gortec’s investment operations are based in China while targeting the global market, with operational centers established in Shenzhen, Shanghai, Beijing, Hong Kong, and other locations. The firm is committed to investing in outstanding healthcare enterprises worldwide, creating new development opportunities for global capital and medical companies, and assisting entrepreneurs in building great enterprises.