Seven High-Profile Advances from GenTrust Medical Ecosystem: Dk Medical, Genecast, SinoMab, Tiantai Bio, PuraCure, Topcon Medical, and Lifetech Scientific

Jul 05, 2024 10:08 CST Updated 10:08

DK Medtech

Vascular Interventional Balloon Product Developer

▲ The twelfth issue of Gao Tejia Industry Research Journal《Gao·Insights》is about to be released. The core report of this issue, 《Great Application Potential Demonstrated in Multiple Fields: The Trillion-yuan Autoimmune Drug Market in China is Rapidly Emerging》, provides an in-depth analysis of the R&D and technological trends of new autoimmune drugs in China.

NearGortka Invests in Multiple Members of the Medical EcosystemDK Medtech, Singlera GENOMICS (SHANGHAI) Ltd., Sican睿奇, Tian广实, Purui Benchmark, Tupai Medical, Xintai MedicalAchieved multiple clinical and commercial advancements. As a company deeply rooted in China's medical field,As a long-term believer in the healthcare industry, Gao Tejia Investment firmly believes in the broad prospects of the medical and health industry. 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: Completes Hundreds of Millions of Yuan in Series E Financing
Covering almost all fields of vascular intervention‍‍

Recently, DK Medical Technology Co., Ltd. (hereinafter referred to as "DK Medtech") announced the completion of a Series E round of financing worth hundreds of millions of yuan. The funds from this round will be used to strengthen the manufacturing center and commercialization efforts, further enhancing DK Medtech's advantages in technology and product innovation, while simultaneously planning for overseas market investment and expansion. In December 2021, Gortec participated in the investment in DK Medtech.‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

DK Medtech was founded in 2015 as an innovative enterprise specializing in a full range of interventional balloon products, including standard balloons, high-pressure balloons, scoring balloons,NotchDrug-Coated BalloonMore than ten types of balloons. The product line covers cardiovascular intervention, peripheral intervention, andNeurointerventionIn almost all fields of vascular intervention, nowObtained 13 certificatesClass III Medical DevicesRegistration Certificate, Completed 5 Special Class Balloon Pre-market RCT Clinical TrialsBed research, in which DK Medtech's coronary scoring balloon dilation catheter (China Medical Device Registration No. 20223031162), scoring balloon dilation catheter (China Medical Device Registration No. 20223031527), and peripheral scoring drug-coated balloon dilation catheter (China Medical Device Registration No. 20233030980) are all the first products in their respective categories to obtain certification.

On July 1, DK Medtech and Medtronic held the second-phase strategic cooperation signing ceremony in Suzhou Industrial Park, marking the collaboration since 2022.Since the two parties signed the strategic cooperation agreement for the coronary drug-coated balloon project years ago, their cooperative relationship has been upgraded once again. Based on the long-term strategic partnership, the two parties will carry out comprehensive cooperation in promoting the Diamond coronary scoring balloon dilation catheter product in the Chinese market. They will accelerate the commercialization process of this product across China and jointly explore in-depth cooperation directions in the coronary field.

02‍
Singlera GENOMICS: Completed a strategic investment of over 100 million yuan from state-owned assets‍‍‍‍‍‍‍‍
Accelerate the Commercialization Process of Early Cancer Screening‍‍‍‍‍‍‍‍‍‍

July 5, JiangsuSinglera GENOMICS (SHANGHAI) Ltd. (hereinafter referred to as "Singlera GENOMICS"") Announces Completion of Strategic Financing Round Exceeding 100 Million Yuan. This round of financing, strategically invested by Yangzhou Guojin Group, Yangzhou Dingyi, and other state-owned assets at various levels in Yangzhou City, will further consolidate...Singlera GENOMICS (SHANGHAI) Ltd. holds a leading position in the field of early cancer screening and detection, and provides strong financial support for the company's technology research and development, registration production, and commercialization implementation. 2018Singlera GENOMICS (SHANGHAI) Ltd. Secures A+ Round Financing from Gortica Investment.

Since its establishment in 2014, Singlera GENOMICS (SHANGHAI) Ltd., as a leader and promoter of methylation detection technology, provides full-cycle products and services for risk assessment, early screening and detection, medication guidance, and recurrence monitoring of high-incidence cancers. The company boasts a rich product pipeline, covering high-incidence cancer types such as pan-cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal cancer, pancreatic cancer, and thyroid cancer.

In May this year, Singlera GENOMICS (SHANGHAI) Ltd.'s independently developed combined detection kit for the methylation of human Septin9, BCAT1, IKZF1, BCAN, and VAV3 genes (PCR-fluorescent probe method) — ChangAike® — was approved by the National Medical Products Administration (NMPA) and obtained a Class III medical device registration certificate. In May 2023, the company's early detection technology for pancreatic cancer, PDACatch, received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). It has also launched LDT services in the United States in collaboration with third-party testing institutions. Additionally, in the field of multi-cancer early detection, the company has independently developed a blood test for five cancers of the digestive system.PolygenicThe methylation detection technology GutSeer® enables early detection of five highly prevalent digestive system cancers—gastric cancer, colorectal cancer, liver cancer, esophageal cancer, and pancreatic cancer—in a single test, offering broad market prospects and significant social value. While continuously strengthening product development and registration, Singlera GENOMICS has also achieved positive results in commercialization and has expanded its international business to more than a dozen countries and regions, including the United States.

03‍‍
Sicong Ruiqi: 3HP-2827 Granted FDA Fast Track Designation

United StatesOn July 2, Sicon睿奇 (Shanghai) Pharmaceutical Co., Ltd. ("Sicon睿奇" for short) announced that its self-developed FGFR2 inhibitor, 3HP-2827, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of cholangiocarcinoma patients with FGFR2 mutations. Previously, 3HP-2827 had been approved to conduct clinical trials in both China and the U.S., and is currently recruiting subjects. In December 2021, Sicon睿奇 completed its Series A round of financing, led jointly by Gao特佳.

3HP-2827 is a highly selective FGFR2 inhibitor independently developed by Sicon睿奇, which can specifically inhibit FGFR2 phosphorylation, thereby suppressing the FGFR2 signaling pathway and exerting anti-tumor effects. It offers a more efficient and safer treatment option for patients with FGFR2 abnormalities, especially those with drug resistance.

Sicongruiqi focuses on the exploration and development of highly selective small-molecule chemical drugs, highly selective antibody biologics, next-generation ADC drugs, and innovative dual-target drugs. The company primarily concentrates on areas such as oncology, cancer immunotherapy, and autoimmune diseases, aiming to enhance drug selectivity, medication safety, resistance prevention, and therapeutic windows, thereby providing patients with more effective and safer treatment options and medications.

04‍‍
Tian Guangshi: Published in The Lancet Sub-Journal
Clinical 1b/2 Phase Research Results of the New Generation CD20 Antibody MIL62

Recently, eClinical Medicine, a subsidiary of the authoritative international journal The Lancet, published the Phase 1b/2 clinical research results of MIL62 recombinant humanized monoclonal antibody injection, led by Professor Shi Yuankai from the Cancer Hospital of the Chinese Academy of Medical Sciences, in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma. This study aims to evaluate the efficacy and safety of MIL62 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma and marginal zone lymphoma.

As a multi-center, open-label phase 1b/2 clinical study, this research enrolled a total of 54 patients with relapsed/refractory FL and MZL. The results showed that the overall objective response rate (ORR) of MIL62 in combination with lenalidomide was 86.0%, surpassing the pre-specified threshold of ≥65%; a cumulative total of over 31 participants achieved either complete response (CR) or partial response (PR), reaching the primary endpoint set for the study. This research further demonstrates that MIL62 can overcome resistance to first-generation CD20 antibodies, offering a potential new treatment option for CD20 monoclonal antibody-refractory FL patients.

The core product of Tiangangshi, MIL62, is a self-developed innovative third-generation CD20 recombinant humanized monoclonal antibody. The product was developed based on an independently innovated ADCC-enhanced antibody platform and has received support from the National Major New Drug Creation Special Project. The Center for Drug Evaluation of the National Medical Products Administration has officially included MIL62 for the treatment of primary membranous nephropathy (PMN) as a "breakthrough therapy" drug category. In addition, ongoing clinical trials of MIL62 also include refractory FL, systemic lupus erythematosus (SLE), and neuromyelitis optica spectrum disorder (NMOSD). In the future, as the clinical research of MIL62 continues to advance, it is expected to bring more effective and safer medication options to patients in China, addressing unmet clinical needs.

05‍
Precegen: Empowering Hengrui Medicine‍
Fluzoparib Approved for New Indication in Ovarian Cancer

Recently, Hengrui Medicine developed a Class 1 new drug, the PARP inhibitor Fluzoparib Capsules (Airie).^®) New indications have been approved for marketing, used for maintenance treatment in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete or partial response after first-line platinum-based chemotherapy. From January 3 to 5, 2024, the Precision Reference Center Laboratory assisted Hengrui Medicine in accepting and successfully passing the on-site inspection by the Center for Food and Drug Inspection (CFDI) of the National Medical Products Administration, providing efficient support for the approval of the new indication.

Preceision Medicine has been deeply engaged in the R&D services for pharmaceutical companies related to synthetic lethal drugs targeting DDR for many years, forming a complete DDR solution from preclinical to commercialization stages, and from services to products. Its relevant services and products have been recognized by dozens of internationally renowned pharmaceutical companies, including Hengrui Medicine. Currently, Preceision Medicine has undertaken more than 30 clinical projects involving 18 DDR inhibitors, with service stages covering from preclinical to Phase I-III clinical trials.

Precise Biomarker is a novel platform company driven by "multi-omics + data mining," focusing on differentiated R&D strategies for innovative drugs. The company, with advanced multi-omics technology, bioinformatics, and AI algorithms at its core, is based on AIBERT, an AI-driven massive multi-omics data mining system developed independently over several years.^®, providing innovative services to pharmaceutical and biotech companies, including world-leading 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. In September 2019, Precise Dx completed its Series B financing round led jointly by GaoTJ Capital.

06‍
Tupai Medical: Tupai Beiming Becomes Biomarker‍‍‍
and Cognitive Research Project (BIOCIS) Only Equipment Made in China‍‍‍‍‍‍‍‍‍‍‍

The Biomarkers and Cognition Study, Singapore (BIOCIS) is a five-year longitudinal study initiated by the Lee Kong Chian School of Medicine at Nanyang Technological University in Singapore, with participation from Duke-NUS Medical School, the First Affiliated Hospital of Sun Yat-sen University, and the School of Social Sciences at Nanyang Technological University. The aim of this study is to investigate the underlying mechanisms of cognitive impairment and dementia by collecting fluid biomarker profiles, neuroimaging and retinal changes, neuropsychological and clinical outcomes from a multi-ethnic population in Southeast Asia. Details of its research plan have been published in the top-tier international journal JPAD.Namely, *Journal of Prevention of Alzheimer's Disease* (Impact Factor 6.4).

Among them,Data collection of the fundus retina will use Tupai Medical's self-developed technology.400,000-speed ultra-wide-field full-range swept-source OCTACollecting information on retinal and choroidal structures, blood flow, etc., this is also the first time that Tupai technology has been included in an overseas research project.。

Currently, Tupai Medical has completed the layout of four major product lines: OCT, microscope, ultra-wide-angle camera, and biometer. Its phacoemulsification and vitrectomy, femtosecond laser...Light and other ongoing projects have also made critical progress. Since its establishment, Tupy Medical has relied on China's optoelectronic industry and scientific research institution resources, focusing on the independent research and development of key optoelectronic components. When the functionality of product systems was limited by components, the company was still able to achieve performance breakthroughs vertically through underlying technology. This model has also driven technological progress in the field of medical optoelectronic components in China, demonstrating the direct promotion of new quality productivity for medical device enterprises. In June 2024, Tupy Medical's D-round financing was successfully invested by Gortica Investment.

07‍‍
XinTai Medical: The First Chinese-Origin Biodegradable‍
Clinical Research Results of ASD Occluder Officially Unveiled

From June 27 to 30, the 18th Oriental Congress of Cardiology and World Congress of Cardiology was held at the Shanghai International Conference Center. On June 28, Professor Wang Shouzheng from the team of Professor Pan Xiangbin of Fuwai Hospital, Chinese Academy of Medical Sciences, formally announcedMemoSorb^®BiologicalDegradable ASDOccluderOne-year follow-up results of clinical research, which strongly validatedMemoSorb^®BiodegradableThe active efficacy and safety of the ASD occluder fully demonstrate its strong potential as an innovative structural heart device originally developed in China.

ThisMemoSorb^®The ASD Occluder, independently developed by a Chinese scientific research team, is the first biodegradable ASD occluder in China. With its unique biodegradability and innovative structural design advantages, it addresses the current clinical challenges of permanent retention of occluders in patients after implantation, obstruction of the establishment of left-heart interventional pathways via trans-septal puncture, and unsuitability for patients with metal allergies. This provides a new treatment option for more patients with atrial septal defects.

XinTai Medical is committed to providing safe, effective, and innovative medical solutions. It is a pioneer in China's structural heart disease interventional medical device industry and a major supplier of congenital heart disease occlusion devices produced in China. It is also the trailblazer in biodegradable technology within the structural heart field and a practitioner of the concept "Intervention without Implantation, Implantation without Residue."

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About Gortec Investment

Gao Tejia 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, covering all stages including M&A, PE, VC, and angel investments. With a professional investment team that is among the few in China deeply focused on the healthcare track, it has built 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 160 invested companies (more than 100 of which are in the healthcare sector), Gortica has successfully facilitated the IPO of 36 companies. Gortica's investment business is rooted in China while targeting the global market, 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 healthcare enterprises, and assisting entrepreneurs in building great companies.