▲ The twelfth issue of Gao Tejia Industry Research Journal《Gao·Insight》has been officially released. The core report,《Great Application Potential Demonstrated in Multiple Fields: China's Autoimmune Drug Market is Rapidly Emerging》, provides an in-depth analysis of the R&D and technological trends of new autoimmune drugs in China. Click on the image to read immediately.
Recently, several members of the Gao Tejia investment medical ecosystem, including TowardPi, United Imaging, Tian Guangshi, Zhonghui Biotech, Sidance, Boan Biotech, and Henlius, have made significant clinical and commercial progress. As a long-term believer in China's healthcare industry, Gao Tejia...TEJIA Investment firmly believes in the broad prospects of the healthcare industry and will continue to seek out innovative companies that truly meet clinical needs and deliver value, supporting the rapid growth of more healthcare enterprises in China.
TowardPi: In Collaboration with OCULUS Brasil
Establish Strategic Partnership
Recently, TowardPi announced the official signing of a partnership with OCULUS Brasil, appointing it as the exclusive distributor of TowardPi in Brazil. This significant milestone marks the beginning of a powerful collaboration aimed at providing cutting-edge ophthalmic technology to medical professionals across Brazil, a key market in South America.
"This is another collaboration between TowardPi Medical and OCULUS Brazil, following their partnership in OCULUS Spain. It demonstrates the high level of trust this prestigious century-old company places in TowardPi Medical's cutting-edge technology," said Mr. Zhou Jian, Vice President of International Affairs at TowardPi Medical. "We believe that our cooperation with OCULUS Brasil will further enhance ophthalmic care in the Latin American region. Together, we will bring TowardPi’s innovative solutions, such as the BeiMing BMizar, which holds the current world record for OCTA speed at 400,000 Hz, to clinics and hospitals across Brazil, providing outstanding care for ophthalmologists."TowardPi's global distribution and service network now covers Europe, Asia, and Latin America. With the recent successful attainment of EU CE certification, TowardPi products are accelerating their entry into the international high-end medical market.In June 2024, TowardPi Medical secured 200 million yuan in D-round financing from GaoTJia Investment.
TowardPi's Vice President of International Affairs, Zhou Jian (left), and OCULUS Brasil CEO Enrico J. Nitschke (right) sign a cooperation agreement at the EURETINA conference in Spain.
UNITED IMAGING: More Than Ten AI Applications
Approved CE and FDA Certifications
Recently, UNITED IMAGING's AI applications have been密集获批国际认证. Nine AI applications received CE certification, assisting doctors in the precise diagnosis of heart, brain, and lower limb vascular diseases; five applications received FDA certification, including VR, MIP, probe maps, MPR, CPR, SCPR and other multi-dimensional panoramic views, intelligent automatic segmentation and personalized editing, empowering doctors to diagnose vascular diseases.
UNITED IMAGING's 5 Applications Approved by FDA
Previously, UNITED IMAGING's PET/CT computer-aided diagnosis software, intelligent lung nodule screening and follow-up system, intelligent pneumonia analysis system, and intelligent rib fracture analysis system received CE certification. To date, a total of 13 AI applications have been approved with CE certification. Meanwhile, UNITED IMAGING's CT intelligent fracture analysis system and three AI algorithms for empowering devices have been approved by the FDA. To date, a total of 9 AI applications have received FDA certification.With its high clinical value, UNITED IMAGING's AI applications have gained recognition from customers in more than ten countries, including the United States, Saudi Arabia, Bosnia and Herzegovina, South Korea, India, Indonesia, and Thailand. In the future, UNITED IMAGING will leverage advanced comprehensive medical AI innovations to expand and deepen cooperation and product implementation both domestically and internationally, making medical AI accessible to broader populations worldwide.Tian Guangshi Bio: MSC303 for Injection
Clinical Research Trial Approved
Recently, Beijing Tian Guang Shi Biotechnology Co., Ltd. (874070) announced that its wholly-owned subsidiary has received the "Drug Clinical Trial Approval Notice" (Number: 2024LP02005) issued by the National Medical Products Administration, approving the Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and efficacy of MSC303 Injection for subcutaneous administration in treating immune-mediated glomerular diseases.
MSC303 is a bispecific antibody targeting CD20/CD3, and the approved indication for this clinical trial is immune glomerulonephritis. MSC303 can simultaneously exert B-cell killing effects and enhance B-cell killing through T-cell activation, more broadly eliminating B cells infiltrating immune organs and tissues to achieve deeper B-cell depletion, thereby reducing the production of autoantibodies for the treatment of autoimmune diseases.Epidemic glomerular disease refers to primary or secondary glomerular lesions caused by abnormal activation of humoral immunity, cellular immunity, or complement. Immune-mediated glomerular disease is one of the main causes of end-stage renal disease (ESRD). Currently, glucocorticoids and immunosuppressants are mainly used for treatment. However, some patients show poor response or intolerance to approved biologics and/or standard regimens, or experience recurrence after discontinuation, creating an urgent need for novel targeted drugs. At present, several CD20/CD3 bispecific antibodies have been approved for hematological tumor indications, but no other products have been approved for clinical use in immune-mediated glomerular diseases.
Zhonghui Bio: Innovative Adjuvant Research and Development Field
Made Breakthrough Progress
Recently, the research and development team of Yihui Bio, a wholly-owned subsidiary of Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd., has made breakthrough progress in the field of innovative adjuvant research and development.The research成果 titled "Dual-functional Emulsifier Based Nano-Emulsion Adjuvant Effectively Enhanced Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine in Mice" was published online in the internationally renowned journal *Journal of Drug Delivery Science and Technology* in the field of drug delivery.
The company's R&D team, targeting different types of immune responses and combining the structural characteristics of immune stimulants, has taken the lead in adopting emulsifiers with immune-stimulating functions to develop a highly efficient preparation process while ensuring safety. This has led to the development of a unique nano-emulsion adjuvant. Animal experimental results show that using this adjuvant, paired with recombinant protein antigens independently developed by Zhonghui Biotechnology, can effectively stimulate the body's humoral and cellular immune capabilities. Compared with the MF59 and aluminum/CpG adjuvant systems, it demonstrates significant advantages. Currently, this adjuvant can already be produced under GMP conditions, and the invention patent application for "a nano-emulsion adjuvant (application number 2023103883104)" based on this adjuvant has entered the substantive examination stage.
ZH Bio actively invests in the innovative adjuvant field, focusing on the R&D direction of "nano-adjuvant formulations, novel immunostimulants, and composite adjuvant systems." Based on antigen characteristics, it develops proprietary adjuvants and production processes aimed at efficiently enhancing immune responses, reducing the risk of adverse reactions, and decreasing antigen usage. The company is independently developing multiple adjuvants, which are gradually being applied to various innovative products such as pneumococcal polysaccharide conjugate vaccines, recombinant herpes zoster vaccines, and recombinant respiratory syncytial virus vaccines.
Stancell: The International Authoritative Journal "JAMA Oncology"First Report on CAR-T Therapy Breakthrough in Solid TumorsRecently, the authoritative international oncology journal "JAMA Oncology" published the clinical research results of GCC19CART, independently developed by Sidance Biotechnology Co., Ltd., in metastatic colorectal cancer. This study represents an important milestone in the field of CAR-T cell therapy for solid tumors, particularly in the treatment of metastatic colorectal cancer (mCRC).
This study was conducted in collaboration between Sidansai Biotechnology and the research group of Professor Cui Jiuwei from the Cancer Center of the First Hospital of Jilin University. The first author is...Deputy Chief Physician Chen Naifei. The published results highlight the successful application of GCC19CART therapy in mCRC patients who have undergone multiple lines of standard treatment. At a dose level of 2x10^6 CAR-T cells per kilogram of body weight, an objective response rate (ORR) of 57% and a median overall survival (mOS) of 26.1 months were achieved. In addition to the 57% ORR, patients who responded had approximately a 75% chance of remaining alive two years later. This therapy was applied as a single treatment modality without being combined with other drugs or treatment methods.Stemirna is a clinical-stage biotechnology company focused on developing CAR-T cell therapy products for solid tumors. Its unique CoupledCAR platform technology aims to overcome key challenges in treating solid tumors. CAR-T products developed based on this platform technology have already achieved promising clinical results in the treatment of advanced solid tumors such as colorectal cancer and prostate cancer. The company’s CAR-T cell therapy product for advanced colorectal cancer, GCC19CART, has received clinical trial approval and Fast Track designation from the U.S. Food and Drug Administration (FDA). Currently, the U.S. clinical trial CARAPIA-1 is underway, with the clinical trial number: NCT05319314. Stemirna is also developing a rich pipeline of CAR-T candidates targeting other solid tumors, including prostate cancer and pancreatic cancer.Boan Biotech: Strategic Cooperation Reached with Haier Biomedical
Exploring Digital Innovation in the Pharmaceutical Industry
Recently, Shandong Boan Biotechnology Co., Ltd. (6955.HK) and Qingdao Haier Biological Medical Technology Co., Ltd. (688139.SH) signed a strategic cooperation agreement. The two parties will engage in in-depth exchange and cooperation in the fields of digitalization, automation, and AI-integrated collaboration to promote the digital innovation and development of the pharmaceuticals industry, facilitate the transformation of achievements, and extend the reach of both parties' products and services.
According to the agreement, Boan Biotech and Haier Biomedical have formed a core strategic partnership. Haier Biomedical will upgrade the digital system for Boan Biotech and customize digital scenario solutions based on Boan Biotech's needs, covering business areas such as EMS DataManager data analysis, QC-Sample Manager sample management system, and EBR electronic batch records, to enhance Boan Biotech's manufacturing capabilities.The digitalization level of craftsmanship and quality management. At the same time, both parties will fully utilize their respective resource advantages, employing cutting-edge technologies such as data analytics, automation, and AI integration to explore innovative directions for digital transformation in the pharmaceuticals industry.In recent years, Boan Biotech's manufacturing system upgrade has made significant progress, receiving strong support and recognition from the government. In 2022, Boan Biotech’s "Antibody Perfusion Culture Technology and Continuous Production Technology Research and Industrialization" was selected as a major industrial project under Shandong Province's New and Old Kinetic Energy Conversion initiative. In 2024, Boan Biotech was recognized as a provincial-level digital workshop in Shandong. Moving forward, Boan Biotech will continue to explore and establish a digital governance model that aligns with its development path, striving to become a representative of new productive forces in the pharmaceutical industry.
Wang Xin, Quality Director of Boan Biotech, and Liu Rundong, Director of Smart Lab Scene at Haier Biomedical, signed the agreement; Jiang Hua, Chairman and CEO of Boan Biotech, and Yu Jianqiang, General Manager of General Lab Equipment Industry at Haier Biomedical, attended the ceremony and jointly witnessed the signing of the agreement.
Fuhong Hanlin: PD-1 Inhibitor
Pembrolizumab Biosimilar Approved for Clinical Use
Recently, Henlius (2696.HK) announced that the clinical trial application for its self-developed biosimilar of pembrolizumab, HLX17 (recombinant anti-PD-1 humanized monoclonal antibody injection), has been approved by the National Medical Products Administration, intended for the treatment of melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair-deficient tumors, gastric cancer, and all other indications for which the original pembrolizumab has been approved in China.
HLX17 is a pembrolizumab biosimilar independently developed by Henlius. In accordance with the requirements of the biosimilar guidelines issued by the National Medical Products Administration (NMPA), and with reference to the EU and U.S. biosimilar guidelines, it has undergone pharmaceutical comparison and preclinical studies.Pharmacology, pharmacodynamics, pharmacokinetics, and immunogenicity studies demonstrate that HLX17 is similar to the original pembrolizumab.
In recent years, immunotherapy has provided a new approach for cancer treatment, with its unique therapeutic advantages and enormous potential being successively validated. By binding to the PD-1 receptor on T cells, HLX17 can block the interaction between PD-1 and PD-L1, PD-L2 on tumor cells, relieving the immunosuppression mediated by the PD-1 pathway, including anti-tumor immune responses, thereby restoring the immune surveillance and killing ability of T cells against tumors, leading to tumor apoptosis. Based on the company’s integrated platform advantages in the field of antibody drugs, Henlius has accelerated the development and strategic positioning of immunotherapeutic agents. Focusing on immune checkpoints such as PD-1/L1, CTLA-4, LAG-3, and TIGIT, it has built a rich product pipeline, which is not only expected to achieve breakthroughs in more indications but also lays a solid foundation for subsequent synergy with other products of the company and combination with innovative therapies.
GaoTJ 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 primarily led by strategic equity investments, covering all stages including M&A, PE, VC, and angel investments. It has one of the few professional investment teams in China that deeply focuses on the healthcare track, building an investment ecosystem platform for the healthcare industry, and is committed to becoming a healthcare investment institution with global influence.With assets under management exceeding 20 billion yuan, 35 healthcare industry funds, and over 170 invested companies, more than 110 of which are in the healthcare sector. Gortica's investment business is rooted in China and oriented globally, 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.
