Chenxing Capital Portfolio Highlights: December 2025 – Multiple Companies Advance with Regulatory Approvals, Strategic Partnerships, and Funding

Recently, the TCR-TCE (T-cell Receptor-T-cell Engager) drug CRPA1A2 Injection, independently developed by Beijing Kerui Biological Technology Co., Ltd. ("Kerui Bio" for short), has officially received the Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This milestone not only marks the world’s first TCR-TCE drug targeting MAGE-A1 positive and HLA-A*02:01 positive advanced solid tumors entering international clinical research but also sets a record as the first TCR protein drug from a Chinese company to enter clinical trials, demonstrating the global competitiveness of Chinese innovative pharmaceutical companies in the field of precision oncology.

MAGE-A1, as a cancer/testis antigen, is expressed at medium to high frequency in various solid tumors such as liver cancer, squamous cell carcinoma of the lung, esophageal cancer, head and neck cancer, and gastric cancer, with a positive rate of 20%-60%. It is basically not expressed in normal somatic cells of the human body but is present only in testicular tissue lacking HLA-I molecules (which cannot present MAGE-A1 to form antigenic epitopes). This highly tumor-restricted expression pattern provides CRPA1A2 with an inherent safety margin, enabling it to "precisely target" and attack tumor cells while minimizing damage to normal tissues. Combined with the high carriage rate of HLA-A*02:01 in the global population, this establishes a broad population coverage foundation for CRPA1A2.

More notably, the TCR molecule adopted by CRPA1A2 is derived from Beijing Kerui Biological Technology Co., Ltd.'s independently developed SMART-TCR® affinity optimization platform. While significantly enhancing the affinity and functional activity of the TCR, this platform rigorously eliminates potentially cross-reactive clones, ensuring excellent specificity for the MAGE-A1/HLA-A02:01 complex. The dual advantages of tumor-specific antigens and highly precise TCR molecules provide CRPA1A2 with a "safety + precision" double insurance, which is expected to effectively avoid the common on-target/off-tumor toxicity risks associated with traditional membrane surface antigen-targeting TCE drugs, enabling safer and more precise immune attacks on solid tumors.

Following the approval of this IND, Kerui Bio will immediately initiate a global multicenter Phase I clinical trial to primarily evaluate the safety, tolerability, and preliminary efficacy of CRPA1A2 injection in patients with advanced solid tumors.

Recently, Hefei Hanmicroorganism Technology Co., Ltd. has achieved significant research and development progress! The company's self-developed innovative live bacterial drug — IBNI617 enteric-coated capsules — has officially received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for its Investigational New Drug (IND) application!

IBNI617 is the first product in Hefei Hanmicroorganism Technology Co., Ltd.'s pipeline for neurological disorders. It has previously received clinical trial approval from the U.S. FDA, becoming a global "leader" in the brain-gut axis antidepressant field. The recent approval by China's NMPA marks the drug's official entry into the clinical research phase in China, simultaneously establishing dual clinical development pathways with both the U.S. FDA and China's NMPA, achieving a global strategic layout.

Unlike traditional treatment options, IBNI617 enteric capsules leverage the unique microbiota mechanism of "live bacteria gut colonization and metabolite regulation" to directly address the clinical pain points of slow onset and significant side effects associated with current first-line antidepressants. This presents a novel treatment concept, offering a safer, more advantageous, and sustainable "green" therapeutic alternative for patients with depression. The NMPA approval of IBNI617 enteric capsules marks a critical step in translating "gut-brain axis" research from theory to clinical practice.

In the future, Hefei Hanmicroorganism Technology Co., Ltd. will continue to focus on the innovative track of live bacterial drugs, accelerating the clinical research process of the IBNI617 enteric capsule in China, driving breakthroughs and applications of gut microbiota drugs globally with hardcore scientific research capabilities and efficient clinical execution.

A relevant official from Chengdu Medical City stated: "Today, we are witnessing not only the culmination of wisdom from the collaboration between Radiometer and illumax, injecting strong momentum into the pharmaceuticals and healthcare industry in Western China, but also evidence of the continuous optimization of Wenjiang's industrial ecosystem and its vibrant innovative vitality. In the future, Wenjiang will continue to provide businesses with a first-class business environment with the sincerity of ‘non-interference unless necessary, always responsive when needed,’ helping enterprises thrive on this promising land and jointly creating a new industrial landscape."

The two flagship products resulting from this collaboration—the QC90 and QC95 series of fully automatic chemiluminescence immunoassay analyzers—are designed to continue the "rapid and reliable" diagnostic speed characteristic of Radiometer Medical products in critical care settings such as chest pain centers, emergency departments, and ICUs. Utilizing chemiluminescence detection methods and single-dose reagent strip designs, these products ensure precise results and user-friendly operation while maintaining testing flexibility, minimizing reagent waste, and accommodating a broader range of clinical scenarios. They provide clinicians in critical care with efficient and dependable diagnostic decision-making support. The two products deeply integrate Radiometer Medical’s globally leading technological expertise in point-of-care testing for critical conditions and illumax’s R&D and industrialization experience in China’s IVD sector, setting a benchmark for "global leadership + local innovation."

Recently, Precision Scientific announced the completion of a new round of financing, with a total amount exceeding 100 million yuan. This round of financing was jointly led by Salubris, Guangdong Investment Capital, and ShenHong Zhongheng Fund, with existing shareholders Jingu Hui Feng and Ju Yi Investment participating in the investment.

Precision Scientific has long been dedicated to the "biology + AI" field, continuously exploring applications that combine biology with AI and computational methods. The company has developed AIBERT, an AI-driven system for mining massive multi-omics data in new drug research and development. By analyzing multi-omics data, AIBERT provides decision support for differentiated strategies in new drug development, including innovative target discovery/evaluation, indication selection, novel biomarker discovery, resistance mechanism research, and combination therapy exploration. The company also addresses unmet clinical testing needs by analyzing omics data to discover multiple innovative disease biomarkers. Based on these novel biomarkers, Precision Scientific collaborates with several academicians and clinical experts to develop world-leading diagnostic products (focused on gynecological oncology). Additionally, the company has developed ProT-Diff, a generative AI algorithm that integrates large protein models with diffusion models to design and optimize peptides/proteins, achieving excellent results.

The company provides "dry and wet combined" central laboratory services, featuring innovative biomarker discovery. It has further developed a central laboratory of international standards, with CAP and CLIA certifications, thereby offering pharmaceutical enterprise partners one-stop biomarker and bioanalytical solutions.

This round of financing will focus on supporting Precision Scientific in its deepened layout in the "biology + AI" field, accelerating AI-driven drug research and innovative breakthroughs. This includes the continuous upgrading of the AIBERT multi-omics data mining platform, the ProT-Diff peptide AI design platform, and the "dry-wet combination" central laboratory, as well as the research and development and registration approval of innovative testing products.

As AI technology continues to achieve breakthroughs, the traditional drug development model is undergoing profound changes. Precision Scientific, based on "biology + AI," persists in innovation and continuous cooperation with the industry, supporting the R&D upgrade and internationalization of China's pharmaceutical and biotechnology sectors.

Recently, the GBTS targeted sequencing (liquid-phase chip) genotyping technology independently developed by Boraida, after five years of in-depth development and rigorous verification, has officially passed the dual certification of laboratory and product from the Council on Dairy Cattle Breeding (CDCB) in the United States. Boraida has thus become the world's first laboratory to obtain CDCB certification based on full-targeted sequencing technology. This certification is not only an international authoritative recognition of Boraida's technical strength and service capabilities, solidifying China's international voice in the field of agricultural biotechnology, but also means that China's self-developed genotyping technology has received authoritative endorsement for the first time in the highest international standard system for livestock breeding, opening a new chapter in the large-scale application of liquid-phase chip technology in genomic breeding.

The Council on Dairy Cattle Breeding (CDCB), recognized as the authoritative body in the global dairy cattle genomic breeding sector, is renowned for its high-standard, highly demanding, and rigorous genotype evaluation and certification system. CDCB's certification represents the international top-tier level of genotype testing. Since 2017, the CDCB has been exploring the integration of sequencing technology into the genetic evaluation system but has yet to find an ideal solution that significantly improves assessment accuracy over the years.

Coincidentally, Boraida launched the full independent research and development of GBTS targeted sequencing technology in the same year (2017). After several years of technical challenges and product iterations, in 2021, Boraida initiated in-depth technical exchanges with CDCB; in 2023, the special assessment verification was officially launched. During the two-year systematic and multi-dimensional verification, the Boraida team directly faced the stringent standards recognized by the CDCB industry, undergoing comprehensive and extreme stress testing from core aspects such as technical principles, experimental procedures, data consistency, parentage analysis, genetic similarity verification, and genotype imputation accuracy.

This five-year "certification marathon" not only witnessed the entire process of BoriTech's evolution from a technical startup to gaining international recognition but also highlighted the extremely high threshold and hard-earned nature of CDCB certification. To date, only 14 laboratories worldwide have obtained CDCB certification, and BoriTech is the only institution that has successfully broken through with its fully self-developed next-generation liquid-phase chip technology, while all others still rely on the older solid-phase chip solutions.

Even in the face of the CDCB's widely recognized stringent certification standards, the technical performance of Boruida's liquid-phase chip has achieved comprehensive surpassing, significantly outperforming all previously certified chip products. Its data repeatability and consistency both exceed 99.75%, demonstrating that China's breeding gene detection source innovation capability has reached a world-leading level.

In the future, Brightbreed will continue to focus on providing full-chain genetic breeding technical services, deepen technological innovation, expand application scenarios, and collaborate with global partners to jointly promote the livestock breeding industry towards a more efficient, more precise, and more sustainable direction, contributing Chinese wisdom and solutions to ensure global food security and agricultural modernization.

Recently, USTAR's Adenovirus/Rhinovirus Nucleic Acid Detection Kit has been approved by the NMPA as a Class III medical device. This is the 12th testing reagent approved on USTAR's EasyNAT platform and the 6th reagent in USTAR's respiratory testing field!

The detection rate of rhinovirus in China is approximately 16.7%, ranking third in the spectrum of viral respiratory infections. Rhinovirus has a high incidence rate, often causing the common cold and also leading to severe lower respiratory tract infections. The general population is universally susceptible to rhinovirus, especially children under three years old, who mostly exhibit symptoms of upper respiratory tract infections such as cough, sore throat, and runny nose. A few patients may develop viral pneumonia affecting the lungs.

The detection rate of adenovirus in China is about 10.3%, ranking fifth in the spectrum of viral respiratory infection pathogens. Adenovirus is one of the more severe types of community-acquired pneumonia in children, commonly occurring in children aged 6 months to 5 years. It can cause extrapulmonary complications, and severe cases are prone to leaving behind chronic airway and lung diseases. It is currently one of the important causes of infant pneumonia mortality and disability.

USTAR Respiratory Products Have the Following Advantages:

Recently, Ruilaipu Medical obtained the Class II medical device registration certificates for "Valproic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)", "25-Hydroxy Vitamin D Assay Kit (Protein Precipitation Method)", "25-Hydroxy Vitamin D Quality Control Material (Protein Precipitation Method)", and "Iodine Quality Control Material (Inductively Coupled Plasma Mass Spectrometry Method)", officially launching them on the market!

Epilepsy is a common and frequently occurring disease of the nervous system. According to epidemiological data, there are approximately 9 million epilepsy patients in China, with about 400,000 new cases added each year. Antiepileptic drugs (AEDs) are currently the first-line treatment for epilepsy, controlling about 70% of seizures. Valproate is suitable for almost all types of epilepsy and seizures and is one of the most effective broad-spectrum antiepileptic drugs (AEDs), particularly demonstrating outstanding efficacy for various generalized seizures. The "Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: 2017 Edition" states that valproate is recommended for therapeutic drug monitoring (TDM) at Level 1, with a reference therapeutic concentration range of 50-100 μg/mL.

25-Hydroxyvitamin D is the main active form of vitamin D in the human body, known as the "active marker of the sunshine vitamin." Its deficiency or abnormal levels are closely related to various health issues.

25-Hydroxyvitamin D deficiency is a core risk factor for osteoporosis and rickets, and is also associated with increased risks of immune dysfunction, pregnancy complications, cardiovascular diseases, etc. Recommendation: It is advised that populations at high risk of osteoporosis, pregnant and postpartum women, infants, the elderly, and others routinely test their 25-hydroxyvitamin D levels, and those found deficient should receive timely and standardized supplementation to reduce the risk of related diseases (Recommendation Level A) --- Guidelines for the Diagnosis and Treatment of Vitamin D Deficiency and Insufficiency (2023 Edition).

The 25-Hydroxy Vitamin D Detection Kit assists clinicians in quickly and accurately assessing the actual nutritional status of vitamin D in the human body, providing reliable data support for the diagnosis and treatment of bone diseases, pregnancy health management, and immune-related disease screening, thereby facilitating early intervention and precise prevention and treatment of related diseases.

Iodine is one of the essential trace elements in the human body, often referred to as the "element of intelligence." Both long-term insufficient intake and excessive consumption can harm human health. Regular testing of urinary iodine can effectively evaluate iodine nutritional status, improve national quality, and ensure physical health.

Iodine deficiency is one of the causes of hypothyroxinemia. A survey conducted in iodine-sufficient areas found that excessive iodine intake during early pregnancy increased the risk of hypothyroxinemia. Recommendation: It is suggested to identify the causes of hypothyroxinemia, such as iron deficiency, iodine deficiency, or excessive iodine, and treat accordingly (Recommendation Level B) — "Guidelines for the Diagnosis and Treatment of Thyroid Diseases During Pregnancy and Postpartum (2nd Edition)."

Iodine Element Detection Kit can assist clinicians in accurately assessing the nutritional level of iodine in the human body, effectively evaluating nutritional status, and precisely identifying the causes of thyroid diseases, thereby supporting the accurate diagnosis and treatment of thyroid diseases.

Recently, at the finals of the 14th China Innovation and Entrepreneurship Competition Disruptive Technology Innovation Competition, Hangzhou V-Onco stood out among 891 high-quality projects nationwide with its outstanding technological innovation capabilities and industry-leading strength, winning the highest award of the competition and becoming a national winner of this year’s competition. This honor not only highlights Hangzhou V-Onco's profound expertise in the field of disruptive technologies but also injects strong momentum into the company’s future development.

The theme of this competition is "Gathering through Innovation, Advancing with Newness." As a national-level event hosted by the Torch High Technology Industry Development Center of the Ministry of Industry and Information Technology, the finals were held in Hangzhou and organized by the Hangzhou Municipal People's Government, Zhejiang Provincial Department of Economy and Information Technology, and Zhejiang Provincial Department of Science and Technology. Since its launch in August 2025, the competition attracted 891 projects from across China, covering six cutting-edge fields: future materials, future manufacturing, future information, future energy, future space, and future health. After multiple rounds of selection, 163 high-quality technology projects with disruptive potential advanced to the finals, fully demonstrating China's innovative vitality in strategic forward-looking technologies.

In this competition, Hangzhou V-Onco Medical Technology Co., Ltd. gained unanimous recognition from the judges and experts for its core technology breakthroughs and industrial application capabilities. The company is committed to cutting-edge technology research and development, actively engaging in industry sectors such as minimally invasive ablation and energy-based surgical solutions. Through technological innovation, it continuously drives industry transformation. Winning the highest national award in China is a strong endorsement of Hangzhou V-Onco's technical strength, innovative model, and market prospects, as well as the best testament to the team's relentless pursuit of excellence.

After winning this award, V-Onco will be officially included in the high-quality enterprise cultivation system of the Ministry of Industry and Information Technology. Subsequently, it will focus on securing a series of policy supports such as national disruptive technology innovation key special projects, and gain diversified supporting services including incubation, investment, and financing matchmaking. This will inject strong momentum into the team’s subsequent continuous innovation in R&D, technology transfer, and industrial development, helping us to further explore the field of disruptive technologies and create greater industrial and social value.

Recently, the 2025 Artificial Intelligence Medical Device Innovation Task Application and Evaluation Work, jointly conducted by the Science and Technology Department of the Ministry of Industry and Information Technology (MIIT) and the Medical Device Registration Management Department of the National Medical Products Administration (NMPA), has been successfully completed. This initiative was led by the MIIT, with guidance and evaluation provided jointly by the Science and Technology Department of the MIIT and the Medical Device Registration Management Department of the NMPA. The aim is to encourage companies to tackle core artificial intelligence technologies and promote innovative breakthroughs in the medical device field. Two portfolio companies of ChenDe Capital have been honored as leaders in this initiative.

This "open competition for innovation" initiative focuses on three major categories and nine key areas, including intelligent decision-support products, brain-computer hybrid intelligence products, and supporting environments. It aims to gather and select a group of highly innovative entities to collaborate on focused research efforts, promoting the innovative development of artificial intelligence in medical devices and accelerating the implementation of new technologies and products.

The project "Transnatural Orifice High-energy Water Jet Surgical Robot," led by Zhiyu Healthcare and jointly applied for with several top-tier tertiary teaching hospitals and research institutions in China, has been successfully selected for the 2025 Artificial Intelligence Medical Device Innovation Task list by the Ministry of Industry and Information Technology of China.

Zhiyu Medical's project stood out from over a thousand projects recommended from all over China, receiving high recognition from the Ministry of Industry and Information Technology (MIIT), the National Medical Products Administration (NMPA), and evaluation experts. This fully demonstrates the company’s leading advantages in product innovation direction, technical strength, and application prospects. This selection marks Zhiyu Medical's first undertaking of a national-level project task, signifying an important acknowledgment of the company’s technological innovation capabilities and cutting-edge product technology level, and officially integrating the company into the national innovation system.

At the same time, the project "Closed-loop Neuromodulation System for Refractory Epilepsy" submitted by Nowei Medical, a subsidiary of Genlight Neurotech, also stood out from thousands of applications across China and was successfully selected. With its profound expertise and forward-thinking breakthroughs at the intersection of brain-computer interface and artificial intelligence, Genlight Neurotech has gained authoritative recognition at the national level.

Recently, the "Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)" (TB-EASY®), independently developed by hugo biotech, has officially obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA) (Registration No.: National Medical Device Approval 20253402448). This product is China's first approved Class III tuberculosis PCR detection kit based on tongue swab samples, contributing "Chinese wisdom and solutions" to the realization of the "2035 Global Goal to End Tuberculosis."

According to the WHO's "Global Tuberculosis Report 2025," the burden of tuberculosis has risen sharply, and early diagnosis and active detection (active case finding) are key to ending the tuberculosis epidemic. However, traditional testing methods that rely on sputum samples face many bottlenecks, such as difficulties in sampling, a limited number of people who can produce sputum, a high rate of unsuitable specimens, the risk of aerosol contamination, and biosafety concerns, which severely limit testing efficiency.

The tongue swab test has the following advantages: convenient and non-invasive collection, good patient compliance; easy sample acquisition, friendly to patients with little or no sputum; reduces aerosol transmission and lowers safety risks; it is also an ideal specimen for tuberculosis testing.

Relying on hugo biotech's PrimEvo platform, TB-EASY achieves 89.6% sensitivity even in samples with a low bacterial load, thanks to advanced primer design and sample preprocessing techniques. Although the concentration of Mycobacterium tuberculosis complex DNA in tongue swab samples is typically less than 1% of that found in sputum, hugo biotech has effectively overcome this limitation through AI-driven primer optimization and pathogen identification algorithms.

TB-EASY® will provide a more convenient and accurate solution for early tuberculosis detection, fever of unknown origin in outpatient and emergency departments, difficult case diagnosis, and active case-finding strategies across medical institutions at all levels. Together, let's usher in a new era of non-invasive tuberculosis testing!