
Developer of Tumor Immunotherapy and Gene Therapy Technologies

Developer and Manufacturer of Biomedical New Materials

Developer and Producer of Therapeutic Products in the Neurointervention Field
Oral Medical Device R&D and Manufacturer

Innovative Medical Device Solution Provider

Developer and Manufacturer of High-End Medical Imaging Equipment

"Morning Star Brilliance"The column aims to keep track of the latest developments of companies invested in by ChenDe Capital on a weekly basis. On the road to innovative exploration, ChenDe always walks hand in hand with numerous "Chen stars" who strive tirelessly.
Express Preview ·2026/4/1

Beijing Kerui Biological Technology Co., Ltd.Dual Filing in China and the US! Beijing Kerui Biological Technology Co., Ltd.'s First Innovative TCR-TCE Drug CRPA1A2 Receives NMPA IND Approval, Advancing Precision Treatment for Solid Tumors in Clinical Development in Both Countries

illumaxHeavyweight Certification! illumax "Three-in-One" Twin Stars Assemble, X16+X100 Reshape Immunoassay Paradigm with "One Certificate for Multiple Models"

Bio RegenerativeBio Regenerative® Dura Mater and Spinal Cord Biological Patch Successfully Wins Bid in the Beijing-Tianjin-Hebei "3+N" Alliance Centralized Procurement

Wallaby MedicalWallaby Medical Completes Strategic Financing, Optimizes Capital Structure to Accelerate Global Expansion

Shanghai Smartee Denti-Technology Co.,Ltd.Smartee Denti-Technology Invests Nearly 500 Million Yuan to Expand Jiaxing Production Base, Strengthening the Global Invisible Orthodontics "Smart" Supply Chain

Genlight MedicalCrowned with Gold! Epilcure™ Wins Special Recognition Gold Medal at the 51st Geneva International Exhibition of Inventions

SinovisionNational-level Certification! All CT Products Submitted by Sinovision Technology Selected for the 11th Batch of the "Excellent Chinese Medical Device Products Directory"

Hann MicroorganismThe Science and Technology Innovation Project of Anhui Province Led by Hefei Hanmicroorganism Technology Co., Ltd. Officially Launched
Beijing Kerui Biological Technology Co., Ltd.
Dual Filing in China and the US! Kerui Biotech's First Innovative TCR-TCE Drug CRPA1A2 Receives NMPA IND Approval, Advancing Precision Solid Tumor Treatment in Clinical Development in Both Countries
Recently, Beijing Kerui Biological Technology Co., Ltd. (hereinafter referred to as "Kerui Bio") announced that its self-developed TCR-TCE (T-cell Receptor-T Cell Engager) innovative drug CRPA1A2 injection has received clinical trial tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This approval marks the official entry of Kerui Bio's first TCR-TCE product into the clinical research stage in China. Previously, CRPA1A2 had obtained FDA IND approval in December 2025, achieving dual-track clinical progress in both China and the United States.
It is worth mentioning that CRPA1A2 was included in the 30-day channel for the review and approval of clinical trials for innovative drugs this time. From the acceptance on February 28, 2026, to the approval on March 31, the review efficiency was outstanding, reflecting the regulatory authorities' efficient support for the clinical development of innovative drugs. It also reflects the solid advancement of project application quality, research foundation, and clinical transformation preparation work.

The long-term challenges in solid tumor treatment include strong tumor heterogeneity, a high risk of recurrence and metastasis, and limited targetable sites for precise attack. There is an urgent clinical need for innovative therapies that combine high specificity, low toxicity, and deeper therapeutic effects. TCR-TCE, as a significant innovation direction in T-cell engagers, combines the TCR's ability to recognize intracellular antigen-derived peptide-MHC complexes with CD3-mediated T-cell recruitment and activation capabilities. It is considered to have the potential to open new avenues for precision immunotherapy in solid tumors.
Unlike traditional antibody drugs that mainly recognize cell surface antigens, TCR can identify intracellular tumor-associated antigen-derived peptides presented by HLA molecules, thereby reaching a broader range of previously difficult-to-drug tumor targets. This mechanism enables TCR-TCE not only to have greater potential for target development but also to achieve a better balance between precision and safety.
CRPA1A2 Targets MAGE-A1 Positive and HLA-A*02:01 Positive Advanced Solid Tumors. MAGE-A1 belongs to the typical cancer/testis antigens, which are abnormally expressed in various solid tumors such as hepatocellular carcinoma, head and neck squamous cell carcinoma, melanoma, bladder cancer, esophageal cancer, and gastric cancer, while being basically non-expressed in normal somatic tissues, only limited to immune-privileged sites such as testis and placenta. This highly tumor-restricted expression pattern provides an important basis for the precise recognition and safety margin of CRPA1A2.
At the same time, the MAGE-A1-derived peptide can be presented by HLA-A02:01, which is one of the more common Class I HLA molecules in the population. This provides a practical basis for the clinical development and patient coverage of CRPA1A2. Current data shows that the positive rate of MAGE-A1 in different solid tumors ranges from about 20% to over 50%, indicating high clinical development value. In terms of the current global R&D landscape, the advancement of CRPA1A2 is expected to bring new treatment options to relevant patient populations.

The approval of the CDE IND marks another key milestone for CRPA1A2 following the FDA IND approval, further validating Beijing Kerui Biological Technology Co., Ltd.'s R&D and translational capabilities in the TCR-TCE field. With the official launch of clinical research in China, CRPA1A2 will accelerate the completion of safety, tolerability, and preliminary efficacy evaluations under a dual-track clinical framework in both China and the U.S., driving innovative outcomes more rapidly toward patient accessibility.
——Dr. Xie Xingwang
Founder, Chairman and CEO of Beijing Kerui Biological Technology Co., Ltd.
illumax
Heavyweight Certification! illumax "Three-in-One" Twin Stars Assemble, X16+X100 Reshape Immune Diagnostics Paradigm with "One Certificate for Multiple Models"
Following the earlier certification of X16 in February this year, illumax's X100 has recently been officially approved, with the registration certificate number: Sichuan Medical Device Registration Certificate No. 20262220040. With this, illumax’s "three-in-one" multimodal immune diagnostics twins have fully assembled! Even more exciting, this registration certificate adopts a flexible "one certificate for multiple models" strategy, covering single-method and multi-method fusion configurations. Within its extremely compact body, illumax provides the industry with a freely customizable, all-scenario-covered precision diagnostic solution.

NMPA Approval Screenshot
One of the biggest highlights of this certification is that the registration certificate covers various models ranging from a single methodology to a triple fusion. Illumax has broken the traditional notion of "buying equipment must be an all-in-one package," offering customers the ultimate freedom to choose according to their needs.
All-in-One Triple Function Version(Chemiluminescence + Flow Fluorescence + Flow Cytometry):
· Application Scenarios: Emergency, Intensive Care, Rheumatology and Immunology Departments in General Hospitals.
· Core Advantages: One device equals three, panoramic insight, avoids missed diagnoses, maximizes space utilization.
Dual-mode Advanced Edition(Chemiluminescence + Flow Fluorescence / Flow Fluorescence + Flow Cytometry):
· Application Scenarios: Specialty Clinics, Specific Disease Screening Centers.
· Core Advantage: Strong targeting, more cost-effective, meeting specific joint inspection needs.
Single Mode Classic Version(Chemiluminescence Only / Flow Fluorescence Only / Flow Cytometry Only):
· Application Scenarios: Small laboratories, budget-sensitive customers.
· Core Advantage: Ultimate cost-performance ratio, retaining the core advantage of single-person portions, easy upgrade to precise detection.
Commercial Value: No matter how much the customer's budget is, how large the venue is, or how special the requirements are, illumax can provide the optimal solution under the same registration certificate. This "flexible and adaptable deployment" model is exactly the new business approach that is most needed during an industry downturn.
From the breakthrough of X16 in February to the conclusion of X100 today, and further to the flexible strategy of "one certificate for multiple models," illumax is not only selling equipment but also promoting an adaptable and highly risk-resistant operational concept. In a cost-sensitive era, the illumax X series twin platforms enable medical institutions to build a scalable and expandable multimodal testing platform with minimal investment.
Bio Regenerative
Bio Regenerative® Dura Mater and Spinal Cord Biological Patch Successfully Wins Bid in the Beijing-Tianjin-Hebei "3+N" Alliance Centralized Procurement
Recently, the Joint Procurement Platform for Medicines in the Beijing-Tianjin-Hebei region announced the winning results of the volume-based joint procurement of dural (spinal) patch medical consumables. Bio Regenerative's independently developed Class III medical device product — BrainDura® Biological Dural (Spinal) Patch — successfully won the bid in the Beijing-Tianjin-Hebei "3+N" Alliance dural (spinal) patch centralized procurement project. This marks a significant breakthrough for Bio Regenerative in the field of neurosurgical consumables and demonstrates that its core regenerative medicine technology industrialization achievements have gained dual recognition from both the market and the industry.

Bio Regenerative® Dura (Spinal) Patch
The product has the following features:
1.Composite Double-layer Bionic Structure:A bilayer biomembrane sheet prepared by freeze-drying decellularized matrix from bovine pericardium and carboxymethyl chitosan, with one side loose and the other compact, consistent with the structure of autologous dura mater;
2.Excellent Biocompatibility:The material has a dense structure, excellent biocompatibility, and can reduce adhesion between the dura mater (spinal cord) and brain tissue or spinal cord;
3. Flexible operation performance: Sutureable and attachable, meeting the needs of different surgical scenarios, providing clinicians with a convenient operating experience;
4. Promote orderly tissue regeneration: Effectively restore the integrity of the dura mater (spinal cord), promote tissue regeneration, reduce postoperative complications, and significantly improve the quality of life for patients;
5. Optimize Degradation Performance: The degradation cycle matches the tissue healing process, avoiding the "space-occupying effect" caused by the non-degradability of traditional materials.
As a pioneer in the industrialization of regenerative medicine in China, Bio Regenerative has always been committed to transforming cutting-edge regenerative medical technologies into innovative products that benefit human health. This successful bid in the Beijing-Tianjin-Hebei "3+N" Alliance procurement marks another significant market breakthrough for佰睿建®硬脑(脊)膜生物补片 following its receipt of the 2025 Future Healthcare 100 Strong Series [Best Biotechnology Innovation Product Award].
Wallaby Medical
Wallaby Medical Completes Strategic Financing, Optimizes Capital Structure to Accelerate Global Expansion
Recently, Wallaby Medical (WallabyPhenox), a global neurovascular medical technology company, announced the successful completion of a significant equity financing and debt restructuring round, further solidifying the company's financial foundation. The proceeds from this round will be used to optimize the capital structure and accelerate the company’s long-term global growth strategy.
This round of financing was jointly led by Yunfeng Capital, Hillhouse Investment, Huajie High View, Gaorong Venture Capital, Jiachen Capital, and Qianhai Ark Asset Management, with Enlight Medical participating in the follow-up investment.
The strong support from top-tier investment institutions and strategic partners such as Yunfeng Capital, Hillhouse Investment, and Huajie High View fully demonstrates the capital market's high confidence in the continuous expansion of Wallaby Medical’s neurovascular platform. Following this milestone event, Yingmai Medical and Wallaby Medical have completed a strategic merger, forming a comprehensively integrated cardiovascular medical company with further enhanced global presence and influence.
Through this strategic merger, Wallaby Medical will effectively optimize the company's capital structure, enhance operational flexibility, and provide solid support for key strategic initiatives, including the advancement of major clinical studies and the continuous expansion of its global product portfolio.
Wallaby Medical is actively advancing the landmark U.S. PIANO clinical trial, which aims to further expand the application scope of flow diversion therapy and enhance its coverage breadth in the rapidly growing neurovascular segment. The company expects to complete the enrollment of the first patient in the near future.
Meanwhile, the company has launched the TRUST registry study in Europe. As a global multicenter registry study, it aims to systematically evaluate the clinical outcomes of various neurovascular treatment options through real-world data. The launch of the TRUST registry study demonstrates the company's long-term commitment to building robust clinical data in the global market.
This round of financing enables Wallaby Medical to adhere to its tradition of innovation, courage, and disruption. In the spirit of exploration, the company has consistently ventured into frontier areas: in 2012, it was the first to launch the world's first 64-wire flow diverter (p64) and became the first enterprise to validate its technology through a randomized controlled trial; relying on the COATING randomized controlled trial, it confirmed the safety of simplifying the anti-thrombotic regimen to single antiplatelet therapy (SAPT).
While continuously consolidating its existing technological advantages, the company is extending its business reach into cutting-edge innovative fields, including an early-stage Brain-Computer Interface (BCI) platform.
Shanghai Smartee Denti-Technology Co.,Ltd.
Shanghai Smartee Denti-Technology Co., Ltd. Invests Nearly 500 Million Yuan to Expand Jiaxing Production Base, Strengthening the Global Invisible Orthodontics "Smart" Supply Chain
Recently, the invisible braces production base project of Zhejiang Smartee Denti-Technology Co., Ltd. ("Smartee Denti-Technology" for short) was officially signed and settled in Jiaxing Nanhu High-tech Zone (Jiaxing Science and Technology City). The project plans to invest nearly 500 million yuan in total, a key measure for Smartee Group to deepen its presence in Nanhu and optimize its global supply chain layout.

Jiaxing Production Base Effect Picture
As a leading benchmark in invisible orthodontics based in China and serving the world, Shanghai Smartee Denti-Technology Co., Ltd. has been introduced as a key talent enterprise by Jiaxing Nanhu High-Tech Zone. It has consistently focused on the research, design, production, and service in the field of digital orthodontics.
Relying on its hardcore independent innovation capabilities, as of February 2026, Shanghai Smartee Denti-Technology Co., Ltd. has submitted more than 1,060 patent applications domestically and internationally, obtained 772 patent authorizations, and its products have been sold to over fifty countries and regions worldwide.
In the layout of intelligent manufacturing, Smartee Group has currently built up a supply chain network radiating globally — in addition to the production base located in Jiaxing, Zhejiang, the group also has a production base in Ziyang, Sichuan, relying on "China Tooth Valley," and has established a production base in Madrid, Spain overseas to achieve rapid response and localized delivery in the global market.
The Jiaxing Invisible Aligner New Production Base Project, which has been signed and settled this time, covers a total area of about 60 mu and will construct a new plant with a building area of approximately 100,000 square meters. After the completion and operation of the project, the annual production capacity of Smartee’s Jiaxing production base will reach over 50 million customized invisible orthodontic appliances. This significant expansion will further unleash the intelligent manufacturing potential of Shanghai Smartee Denti-Technology Co., Ltd., helping the company maintain its leading position in the new digital dentistry track.
GenLight Medical
Crowned with the Gold Award! Epilcure™ Wins Special Recognition Gold Award at the 51st Geneva International Exhibition of Inventions
Recently, following the silver award won by LaserRO™, Genlight Neurotech has announced another significant piece of good news! At the 51st Geneva International Exhibition of Inventions, another core product, Epilcure™ Implantable Neurostimulation System, received the Special Gold Award with Commendation due to its breakthrough innovation and outstanding clinical value. With two awards in hand, it shines on the global stage of neuro-medical innovation with the strong power of Chinese creation, setting new industry achievements.

Award Ceremony
The International Exhibition of Inventions of Geneva, founded in 1973, is co-organized by the Swiss Federal Government, the Geneva Cantonal Government, the City of Geneva, and the World Intellectual Property Organization. It is one of the world's longest-running and largest-scale invention exhibitions. This year's exhibition features over 1,000 innovative achievements from 35 countries and regions, with a jury composed of more than 80 global independent experts. The awards are strictly evaluated based on core criteria such as innovation, practicality, and technological advancement. Among them, the Special Gold Medal, selected from the Gold Medal projects, is hailed as "the Gold Medal of Gold Medals."
As the core innovative product of Genlight Neurotech, Epilcure™ is China's first implantable neurostimulation system based on brain-computer interface technology, specifically designed for patients with drug-resistant epilepsy. It precisely captures abnormal EEG signals through highly sensitive electrodes implanted in the skull, combined with self-developed recognition algorithms to monitor in real time and automatically initiate intervention programs, effectively alleviating or preventing epileptic seizures.
Sinovision
National-level Certification! All CT Products Submitted by Sinovision Technology Selected for the 11th Batch of the "Excellent Domestic Medical Device Products Directory"
Recently, the China Medical Equipment Association officially released the evaluation results of the eleventh batch of the *Directory of Excellent Domestic Medical Device Products*. All the CT products submitted by Sinovision Technology (Beijing) Co., Ltd. were selected, marking that the company’s technical strength and product quality in the field of domestically produced CT have once again received national-level authoritative recognition.

The CT products selected this time have achieved a full-dimensional layout from ultra-high-end to practical types, and can comprehensively meet the needs of various complex applications and diversified scenarios in clinical settings. Whether it is routine examinations in grassroots medical institutions or high-end precision diagnostics in large tertiary hospitals, the CT equipment from Sinovision Technology (Beijing) Co., Ltd. can precisely adapt to provide reliable imaging diagnostic support for medical professionals.
The Selection of the "Directory of Excellent Chinese Medical Device Products" is organized by the China Association of Medical Equipment. After rigorous technical review, clinical verification, and comprehensive evaluation, it is one of the most authoritative national-level selections in the field of Chinese medical devices. All products submitted by Sinovision Technology (Beijing) Co., Ltd. passed the review at once, fully demonstrating the company's comprehensive leading advantages in CT core technology, image quality, clinical applicability, and reliability.
From grassroots screening to ultra-high-end scientific research, from parameter catch-up to clinical leadership, Sinovision Technology (Beijing) Co., Ltd. is redefining the value boundaries of domestically produced CT with a "full-scene coverage" approach. The inclusion of its full series of products in the directory of excellent domestically produced equipment will further promote the localization of high-end CT equipment. In the future, Sinovision Technology will continue to adhere to independent innovation, deepen clinical cooperation, and provide medical institutions at all levels with more cost-effective and independently controllable medical imaging solutions, contributing solid strength from domestic imaging to the "Healthy China" strategy.
Hann Microorganism
The Science and Technology Innovation Project of Anhui Province Led by Hefei Hanmicroorganism Technology Co., Ltd. Officially Launched
Recently, the launch meeting of the Anhui Province Science and Technology Innovation Tackling Plan project — “Development of Microbial Drugs for the Treatment of Major Chronic Diseases,” led by Hefei Hanmicroorganism Technology Co., Ltd., was successfully held at Hanmicroorganism.

Project Site
Experts from the Life Science and Technology Department of Anhui Provincial Department of Science and Technology, including Xu Yingyuan, Jiang Huihui from the Anhui Rural and Social Science and Technology Development Center, and Hu Peng from the Anhui Institute of Quality and Standardization attended the meeting. The meeting was chaired by Dr. Wen Wen, Chief Operating Officer of Hefei Hanmicroorganism Technology Co., Ltd. and Administrative Director of the project. Professor Zhu Shu, founder of Hefei Hanmicroorganism Technology Co., Ltd. and Technical Director of the project, Dr. Tao Wanyin, Chief Technology Officer of Hefei Hanmicroorganism Technology Co., Ltd. and head of the project, along with experts and key members from Anhui Medical University and its affiliated hospitals, the University of Science and Technology of China and its affiliated hospitals, among other institutions, attended the meeting. Discussions were held on the overall goals, research progress, clinical transformation, and fund management of the project to build consensus and clarify directions for subsequent implementation.
At the beginning of the meeting, Professor Zhu Shu, Chief Technical Officer of the project and founder of Hanmicroorganism, delivered a speech. He pointed out that the project focuses on the development of microbial drugs for treating major chronic diseases, combining scientific frontier research with clinical transformation value, and serving as an important practice of cross-disciplinary and cross-institutional collaborative innovation. He emphasized that the project team should fully leverage the deep integration of basic research and clinical resources, focus on key scientific issues, steadily advance the R&D and transformation process, and generate original results with independent intellectual property rights.
Project leader Dr. Tao Wanyin then reported on the overall status of the project. Focusing on two major chronic diseases—inflammatory bowel disease (IBD) and depression—the project leverages Hefei Hanmicroorganism Technology Co., Ltd.'s self-developed microbial drug development platform to create proprietary live bacterial drugs, which are expected to overcome existing treatment bottlenecks. In the IBD direction, based on earlier mechanistic studies, the project team has developed a new target product, currently conducting central clinical trials in collaboration with several authoritative hospitals. In the depression direction, live bacterial drugs developed based on the "gut-brain axis" mechanism have shown promising symptom relief in early clinical studies, and subsequent efforts will further advance registration clinical trials. Afterwards, attending experts and core members of the project team engaged in an in-depth discussion regarding the project’s progress.
The meeting also conducted a special exchange on the standardized management of scientific research funds. Relevant experts, in combination with the characteristics of the project, provided a systematic explanation on the independent accounting of government special funds and self-raised funds, the organization and archiving of process documents, and cross-unit collaborative management. They emphasized that the project will adhere to the principle of "focusing on the process and strengthening supervision," reinforcing the responsibilities of each participating unit to ensure compliance in fund usage and proper process management. The lead unit, Hefei Hanmicroorganism Technology Co., Ltd., will establish a financial management system for the project, comprehensively promoting the fund management and risk investigation of all cooperating units.
At the end of the meeting, Xu Yingyuan from the Life Science and Technology Department of Anhui Provincial Department of Science and Technology congratulated the project on its successful launch and reviewed the overall arrangements and key points. She hoped that all participants would continue to pay attention to the completion of project targets, implement management requirements in daily work, and ensure the smooth completion of the project.
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Chen De Capital is an investment institution focused on innovative medical technology and cutting-edge biotechnology subfields, managed and operated by a professional team with a deep background in the medical industry, overseeing multiple RMB funds and USD funds.
Chend Capital adheres to the investment philosophy of "Focus, Perfection, and Reputation." Leveraging extensive industry resources in the healthcare sector and years of in-depth research and cultivation, Chend Capital is quick to identify the latest international technological trends and seize investment opportunities driven by innovation. The firm is committed to discovering top-tier enterprises with industry leadership potential and fostering a connected ecosystem through a win-win investment methodology and a precise, pragmatic post-investment empowerment system. By working alongside entrepreneurs to build an industrial ecosystem and grow together, Chend Capital aims to deliver sustainable, superior returns for investors.

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