Home Tongyuan Kang's TY-9591 Outperforms Osimertinib in Head-to-Head Trial and to File NDA; Darui Bio Completes $25M Pre-B Financing

Tongyuan Kang's TY-9591 Outperforms Osimertinib in Head-to-Head Trial and to File NDA; Darui Bio Completes $25M Pre-B Financing

Apr 09, 2025 09:41 CST Updated 09:41
Rona Therapeutics

Nucleic Acid Drug Developer

Salus

Sequencing and Spatial Omics Platform Provider

MEDICAL AI

AI-Assisted Medical Imaging Diagnosis System Developer

H&H Healthcare

R&D and Producer of Interventional Medical Devices for Heart Disease

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Financing Information

1

Rona Therapeutics Announces Completion of $25 Million Pre-B Round Financing

On March 14, 2025, Rona Therapeutics, a clinical-stage platform company that continues to lead in the field of nucleic acid drug research and development, officially announced the successful completion of its Pre-B round of financing, raising US$25 million. This round of financing was led by Guanghua Wutong, with participation from both new and existing shareholders including Boyuan Capital, Lilly Asia Ventures, and Jiangyuan Investment, fully demonstrating continued recognition and confidence in Rona Therapeutics' innovation in the nucleic acid drug field.

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Business Progress

1

"Yuan Mountain Healthcare" Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University Completes the First Officially Charged Nanoknife Ablation Surgery in a Public Medical Institution in the Province

Recently, Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University conducted the first nanoknife tumor ablation surgery using domestically produced nanoknife equipment. The surgery was led by Director Xu Linfeng of the Interventional Department, with close cooperation from the CT room, anesthesiology department, and other departments. They used a domestically produced nanoknife device—the pulse electric field therapy system—developed and manufactured by Salus Medical for treating a patient with locally advanced pancreatic malignancy.

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2

"Salus Medical" Entity List Implementation! Salus Medical's China-produced Preferred Sequencing Solution: A New Choice

On March 4, 2025, the Chinese Ministry of Commerce issued the latest announcement to officially implement measures against Illumina, Inc., a U.S.-based company, as part of the Unreliable Entity List, banning it from exporting gene sequencers to China. As a globally leading solutions provider in genomics and spatial omics and a key player in China’s domestic sequencing sector, Salus remains committed to user needs at its core, focusing on developing proprietary upstream sequencing platforms and offering a series of leading localized sequencing solutions.

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3

MEDICAL AI Obtains the Industry's First Class III Certificate for AI in Real-Time Dynamic Ultrasound Detection

Recently, MEDICAL AI's breast ultrasound imaging auxiliary detection software obtained the "Dynamic Ultrasound AI" NMPA Class III certificate, becoming the first Class III certificate for breast ultrasound AI, marking a significant breakthrough in the field of ultrasound AI. This will also further enhance MEDICAL AI's comprehensive process for breast cancer screening, diagnosis, and treatment.

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4

HuiHe Healthcare's K-Clip®: China's First Transcatheter Tricuspid Valve Device Approved for Marketing

Recently, the K-Clip® Transcatheter Tricuspid Annuloplasty Repair System, independently developed and globally首创 by Shanghai Huihe Healthcare Technology Co., Ltd., has officially received approval from the National Medical Products Administration (NMPA) for market launch! Thus, K-Clip® fills the gap in China's interventional tricuspid valve field, becoming the first domestically produced certified product for transcatheter treatment of tricuspid regurgitation. K-Clip® also ushers in a new era of global TTVA (Transcatheter Tricuspid Valve Annuloplasty) treatment for tricuspid regurgitation, leading international academic research trends.

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5

"NuPulse Medical" Successfully Completes a Severe Aortic Stenosis with Extreme Calcification TAVR Surgery Using Prizvalve® at the Second Xiangya Hospital of Central South University

Recently, Professor Zhou Shenghua and Professor Fang Zhenfei's team from the Second Xiangya Hospital of Central South University successfully completed a highly challenging TAVR surgery using the NewMed Prizvalve® TAV26 valve. The elderly patient suffered from severe aortic stenosis combined with mild regurgitation, significant thickening of the valve leaflets accompanied by extremely severe calcification, with a calcium score of 928mm³ (HU850). This placed extremely high demands on the radial support force of the implanted valve, which required ensuring that the valve's shape remained unaffected after implantation.

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"Tendvia Medical" First Case in Gansu Province | Jiuquan People's Hospital Successfully Treats a Patient with Acute Pulmonary Embolism Using China's First Tendvia® Pulmonary Artery Thrombectomy Stent System

Recently, Director Jing Lei, a member of the team led by Director Rui Xingwu from the Department of Interventional and Vascular Surgery at Jiuquan Hospital of Shanghai First People's Hospital (Jiuquan People's Hospital), successfully performed a pulmonary artery thrombectomy surgery on a 62-year-old male patient with acute pulmonary embolism using Tendvia®, China's first domestically produced pulmonary artery thrombectomy stent system. This surgery marks the first clinical application of the Tendvia® pulmonary artery thrombectomy stent system in Gansu Province since its market launch, further advancing the application and development of interventional treatment techniques for acute pulmonary embolism in Gansu Province.

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7

"SeekOne® DD Single-cell ATAC + RNA Multi-omics Solution Released by SeekPlas"

On March 25, SeekOne Biotech hosted a live broadcast event on single-cell transcriptomics + ATAC technology multi-omics,重磅 releasing the new product — SeekOne® DD Single-cell ATAC + RNA Multi-omics Solution. The event also explored its wide-ranging applications in cutting-edge life science fields. The launch of the SeekOne® DD Single-cell ATAC + RNA Solution not only injects new momentum into this transformative field but also provides researchers with a more powerful, stable, and efficient research platform.

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8

"Refine Medical" Refine® Multi-Port Endoscopic Surgical Robot Receives EU CE Certification

On March 24, the Jingfeng® multi-port endoscopic surgical robot system, independently developed by Jingfeng Healthcare®, officially passed the EU CE certification (MDR). It is suitable for endoscopic surgery in urology, gynecology, general surgery, and thoracic surgery, demonstrating its comprehensive compliance with the highest EU standards in terms of stability, safety, effectiveness, and clinical value. This also signifies that Jingfeng Healthcare® has entered the main battlefield of global medical technology competition with an innovative "Chinese solution," marking a milestone journey in the globalization strategy of China's high-end medical equipment.

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9

"MoYang Bio" Secures China's First Class III 13-09 Production License for Injectable Hydroxyapatite Microspheres Facial Filler

Recently, Shanghai Moyang Biotechnology Co., Ltd. officially obtained the Class III Medical Device Production License (Classification Code: III-13-09) for injectable hydroxyapatite microspheres facial filler issued by the Shanghai Drug Administration, paving the way as the first certification for injectable hydroxyapatite microspheres facial filler products under the classification code III-13-09 in the field of plastic surgery and general surgical implants. This breakthrough not only marks a new phase of high-standard compliance in China’s CaHA medical aesthetics materials sector but also highlights Moyang Biotechnology's leading position in technological R&D, production quality control, and compliance management within the industry.

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Research Progress

1

"Beijing Heng Bio" CD7 Universal CAR-T Therapy IND Application Approved by FDA

On March 1, 2025, Beiheng Bio announced that its universal CAR-T cell therapy CTD402 targeting CD7 has received approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial application (IND) to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II clinical trial using a simplified dose exploration design aimed at optimizing the dosing regimen and accelerating the clinical development process.

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2

Abogen Biosciences' Lyophilized mRNA Vaccine Approved for Clinical Trials

On March 4, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the Investigational New Drug (IND) application for the freeze-dried Respiratory Syncytial Virus (RSV) mRNA vaccine submitted by Abogen Biosciences (application numbers: CXSL2400848, CXSL2400849, CXSL2400850) has received clinical trial authorization by default. This marks a milestone as the first product utilizing Abogen’s proprietary base modification technology to be approved for clinical trials.

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3

"Tongyuan Kang Pharmaceutical" TY-9591 Head-to-Head Defeats Osimertinib, Will Submit for Market Approval

On March 9, 2025, Tongyuan Kang Pharmaceutical announced that TY-9591 showed statistically significant and substantial clinical benefits in a pivotal Phase II clinical trial, head-to-head versus Osimertinib as first-line treatment for EGFR-mutated brain metastatic NSCLC. The iORR achieved the expected goal, with TY-9591 demonstrating statistically and clinically meaningful improvements compared to Osimertinib. Tongyuan Kang Pharmaceutical will submit an application for market approval in the near future.

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4

"Yanming Biotech's Novel Mechanism Tumor Immunotherapy Class 1 New Drug Approved for Clinical Trials in China"

On March 14, 2025, Beijing Yanming Biotechnology Co., Ltd., dedicated to developing revolutionary innovative drugs for the treatment of inflammation and tumors, announced that its self-developed small molecule innate immune agonist PTT-936 with a novel mechanism of action has been approved by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) to conduct clinical research in China, following the approval from the U.S. Food and Drug Administration (FDA) for clinical studies.

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5

Rona Therapeutics Announces FDA Approval for RN0361 to Initiate Phase 2 Clinical Trial

March 17, 2025 – Rona Therapeutics Inc., a global leader in nucleic acid technology within the RNA-targeted therapeutics field, announced that its small interfering RNA (siRNA) candidate drug RN0361 targeting APOC3 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). The company will initiate a Phase 2 clinical trial. The drug is intended for the treatment of severe hypertriglyceridemia (SHTG), mixed dyslipidemia, and familial chylomicronemia syndrome (FCS). Based on the favorable safety profile and sustained triglyceride (TG) reduction observed in a single-dose Phase 1 clinical trial over six months, the upcoming randomized, double-blind, placebo-controlled global multicenter Phase 2 trial will evaluate the efficacy, safety, and durability of RN0361 in patients with hypertriglyceridemia during a nine-month follow-up period.

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6

"Aikang Baifa" Announces Successful Completion of Phase III Clinical Trial for ADHD Treatment Drug Aizhida™

Recently, Shanghai Ark BioPharmaceutical Technology Co., Ltd. announced that the Phase III clinical trial of its new drug Aizhida™ (AK0901) for treating attention deficit hyperactivity disorder (ADHD) in children and adults has been successfully completed. This progress marks a solid step forward for Ark BioPharmaceutical in the research and development of drugs for pediatric psychiatric disorders, with the potential to provide new treatment options and better therapeutic experiences for ADHD patients in China.

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7

Abogen Biosciences' Lyophilized Shingles mRNA Vaccine Approved for Clinical Trials

On March 28, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the Investigational New Drug (IND) application for the freeze-dried herpes zoster mRNA vaccine submitted by Abogen Biosciences (acceptance numbers: CXSL2500001, CXSL2500002, CXSL2500003) has received clinical trial authorization by default. This is another product approved for clinical use by Abogen Biosciences following the recent freeze-dried respiratory syncytial virus mRNA vaccine, further demonstrating the company's excellent innovation platform. In addition, based on the company's protein structure design platform, the approved vaccine features a unique and novel antigen design with full independent intellectual property rights, showing good immunogenicity, durability, and safety in preclinical studies.

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8

"OCUL101 China I/II Phase Clinical Trial Officially Launched by OcuLHealth"

On March 25, 2025, Shenzhen OcuLing Biomedical Technology Co., Ltd. (referred to as "OcuLing") announced that the Phase I/II clinical trial of its core product OCUL101 has officially launched at Shanghai First People's Hospital, the leading institution. Professor Xiaodong Sun, Vice President of Shanghai First People's Hospital and Director of the Ophthalmology Clinical Medicine Center, serves as the principal investigator. Dr. Jiongguang Chen, founder, chairman, and CEO of OcuLing, led the clinical medicine team in attending the launch meeting, marking a new phase in the development of innovative ophthalmic drugs produced in China.

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9

"Zhi Tai Bio" Treats Alzheimer's Disease - Zhi Tai Bio's Innovative Oral GLP-1 Polypeptide Third Indication Approved for Clinical Trials

On March 31, 2025, ZT006 Tablets, an orally administered GLP-1 class peptide independently developed by Beijing Zhide Peptide Biopharmaceutical Technology Co., Ltd., received tacit approval for clinical trials from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the development in the treatment of Alzheimer's disease. Previously, the product’s indications for weight loss treatment in adult patients with obesity or overweight, as well as glycemic control in adult patients with type 2 diabetes, have already been approved for clinical trials in China, and Phase I clinical trials have been initiated.

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Important Cooperation

1

"HaiChuang Pharmaceuticals" Signs Strategic Cooperation Agreement with Sinovac Biotech

On March 19, Hilead Pharma Co., Ltd. (Stock Code: 688302.SH) and Kexing Biopharmaceuticals Co., Ltd. (Stock Code: 688136.SH) held the "Innovation Leads, Synergy Sets Sail" Overseas Strategic Cooperation Signing Ceremony in Shenzhen. The two parties will engage in deep collaboration on the international market development of cooperative products, jointly promoting China-produced innovative drugs to go global. Chen Yuanwei, founder/chairman of Hilead Pharma, Dai Li, operating vice president/board secretary, Zhang Tao, deputy director of the Commerce Department, Zhao Yanqing, president of Kexing Pharma, and Shao Ke, vice president, attended the signing ceremony.

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2

"Refine Medical" Signs Major Strategic Cooperation Agreements with Dornier MedTech, the Global Leader in Urology Surgical Devices, and Poland's Long-standing Medical Group Meden-Inmed

From March 21 to 24 local time in Spain, the 40th Annual Meeting of the European Association of Urology (EAU25) was grandly held in Madrid. At this most influential academic event in the global urology field, as a leading enterprise of China's high-end surgical robot industry, JINGFENG Medical® made a stunning appearance with its multi-port, single-port surgical robots and remote surgery system, and for the first time released overseas the JINGFENG® "three-in-one" surgical solution. At the press conference, JINGFENG Medical® officially announced that it had signed significant strategic cooperation agreements with Dornier MedTech, the global leader in urological medical devices, and Meden-Inmed, a long-established Polish medical group.

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Enterprise Honor

LiGETAI|Awarded the Title of "Shanghai Science and Technology Little Giant Cultivation Enterprise"





Calibra|Ranked on the 2024 Sharp Company List by China Venture





Ocugen|Ranked on Pencil News' "2025 Emerging Future Unicorn List"





BoYuan Honor



China Fund of Funds Research Center | Ms. Chunping Lei, Partner of Boyuan Capital, Awarded "Top 30 Best Female IR in 2025" by China Fund of Funds Research Center





Disclaimer: The information in this report is derived from publicly available materials. Our company makes no guarantees regarding the accuracy or completeness of this information. The copyright of this report belongs solely to our company, and no institution or individual may reprint, reproduce, publish, post, or quote it in any form without written permission.


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