China Renaissance Weekly Report on Healthcare and Life Sciences (Vol. 329)

Jul 22, 2024 09:30 CST Updated 09:30

Rona Therapeutics

Nucleic Acid Drug Developer

Xellar Biosystems

Drug Discovery Service Provider

"China Renaissance Healthcare and Life Sciences Weekly Report" is regularly published, focusing on interpreting the weekly data from a capital perspective and providing the latest industry insights.

Healthcare and life sciences is a field that Huaxing Capital has focused on and deeply cultivated over the years, having served as financial advisor for nearly 200 financing and M&A projects.

Innovation in the medical and life sciences industry continues to emerge, making it one of the most active sectors. Huaxing Capital consistently supports and accompanies the growth of startups in this field, aiming to bring a rational and professional voice to the industry.

Author | Huaxing Capital Healthcare and Life Sciences Team

Follow the WeChat Official Account of Huaxing Capital (ID: iChinaRenaissance), click "Insights" - "Industry Observation" - "Life Science & Technology" in the menu to access more information related to the healthcare and life science industries.

Rona Therapeutics Announces Completion of $35 Million Series A+ Financing

July 19: Rona Therapeutics, a clinical-stage platform company at the forefront of nucleic acid drug research and development, announced the successful completion of a $35 million Series A+ financing round. The round was led by LongRiver Jiangyuan Investment, with participation from investors including Zhaode Investment, Boyuan Capital, Zhongqi Capital, and Lilly Asia Ventures.

Industry Perspective:

Rona Therapeutics is a globally leading nucleic acid innovative drug platform company, focusing on the treatment of metabolic diseases and central nervous system degenerative diseases. Rona Therapeutics is committed to developing the best-in-class siRNA drugs. Its liver-targeted metabolic-related pipeline products show unique differentiation and innovation in cardiovascular diseases, non-alcoholic fatty liver disease, obesity, and kidney diseases. In addition, Rona Therapeutics also focuses on exploring the potential of extrahepatic nucleic acid delivery in the field of central nervous system degenerative diseases. It has successfully established its proprietary extrahepatic delivery platform, aiming to treat a series of complex diseases such as amyotrophic lateral sclerosis and Alzheimer's disease, which are difficult to address with traditional drug therapies.

Xellar Biosystems Completes Angel+ Round Financing Worth Hundreds of Millions

July 17, News: Xellar Biosystems, an innovative biotechnology company, recently announced the completion of an angel+ round of financing worth hundreds of millions of RMB. The round was led by TriApex, with participation from Zenxuan Investment and Tiantu Capital, while existing shareholders Legend Capital and Yae Capital continued to increase their investment. This round of financing will help Xellar Biosystems further develop its AI + organoid chip technology platform and promote its deep application in the field of new drug development.

Industry Perspective:

Xellar Biosystems is the world's first "3D-Wet-AI" biotech startup to integrate organoid-on-a-chip, high-content three-dimensional (3D) cell imaging, computer vision (CV), and artificial intelligence (AI) technologies for drug discovery. In August 2022, Xellar Biosystems completed a $10 million angel round of financing led by Legend Capital, ZhenFund, and Yae Capital.

AusperBio Completes $37 Million Series A Financing

July 15 News: AusperBio, a biotech company, announced the completion of a $37 million Series A financing round. This round was led by InnoPinnacle Fund with additional investments from Vivo Capital, H&Q China, Qiming Venture Partners, and OrbiMed. The proceeds will primarily be used to advance the Phase II clinical trial of AusperBio's potential cornerstone hepatitis B drug, AHB-137, explore combination therapy strategies, and support CMC production and other development activities. Additionally, the funds will also be utilized to expand the proprietary Med-Oligo™ technology platform and its product pipeline.

Industry Perspective:

AusperBio, a clinical-stage innovative drug research and development company operating simultaneously in China and the United States, is committed to developing First-in-class and Best-in-class self-innovative targeted delivery small nucleic acid drugs.

DaiLai Technology Completes First Round of Financing

Recently, Deral Technology completed its first round of investment, led by Fengyu Capital. The funds obtained from this financing will be used for product research and development, registration, team expansion, and the construction of a production center, advancing the clinical trials and certification of core products, and laying the foundation for subsequent industrial sales.

Industry Perspective:

DaiLai Technology focuses on the research and development of human bioelectric sensing technology, machine learning recognition technology, and new human-computer interaction technology, aiming to achieve digital assessment and treatment of movement disorders through the deep integration of bioelectric signals and artificial intelligence.

Westlake Vitech Completes Tens of Millions of Yuan in Strategic Financing

On July 16, Westlake Vitech (Hangzhou) Diagnostic Technology Co., Ltd., a company in the field of erythrocyte folate mass spectrometry, announced the completion of a strategic financing round worth tens of millions of yuan. This round of financing was invested by Hongjia Fund, and the funds will be used for R&D investment, market expansion, etc.

Industry Perspective:

Westlake Vitech is committed to achieving one-stop precision medicine solutions through cutting-edge diagnostic technologies, with business covering third-party medical testing, clinical mass spectrometry applications, mass spectrometry kits, etc. It has established third-party precision medical testing laboratories in Beijing and Hangzhou, set up a GMP-standard production center, and founded a research and development subsidiary in Australia.

Panlin Capital Exclusively Invests in Pre-A+ Round of Capray Biotech, a Provider of Comprehensive Flow Cytometry Solutions

Recently, Henan Capricorn Biotechnology Co., Ltd. announced the completion of a multi-million yuan Pre-A+ round of financing. This round of financing was exclusively invested by Panlin Capital, and the funds will mainly be used for the application of Class III medical device registration certificates in China, innovative antibody research and development, optimization and production of flow cytometers, as well as subsidiary construction.

Industry Perspective:

Caprico Biotech's early technical accumulation was completed at Caprico Biotechnologies, Inc. in the United States. Caprico Biotechnologies, Inc. was established in Atlanta in 2013, possessing core capabilities such as R&D of flow monoclonal antibody cell lines, purification and preparation of flow antibodies, fluorescent dye conjugation, and production quality control of flow antibody reagents. In April 2022, Caprico Biotech adjusted its equity structure to wholly acquire Caprico Biotechnologies, Inc., with Zhengzhou as the headquarters and the wholly-owned subsidiary in Atlanta serving as the innovation and R&D center for flow antibodies. This setup involves investment, R&D, breakthroughs, and validation in the U.S., while industrialization and localization occur within China, forming a national standard implementation.

Synyi Completes New Round of Strategic Financing

Recently, Synyi announced the successful completion of a new round of strategic financing, jointly participated by well-known state-owned investment institutions from Beijing and Changchun, including Beijing Xinhangcheng Fund Management Co., Ltd., Changchun New District Equity Investment Fund Management Co., Ltd., Changchun Equity Investment Fund Management Co., Ltd., and Changchun Changfa Private Equity Fund Management Co., Ltd.

Industry Perspective：

Senyint Intelligent Technology is always committed to applying digital capabilities and artificial intelligence technologies to the healthcare industry, providing digitally intelligent solutions driven by intelligence for medical institutions, health regulatory agencies, government departments, biopharmaceutical R&D organizations, etc. To date, the company has cumulatively released more than 20 innovative digital-intelligent solutions, covering dozens of niche vertical fields such as data management, intelligent diagnosis, operation management, and clinical research, offering strong support for the intelligent upgrading of the healthcare industry.

HuaMeiHaoLian, an AI-driven digital healthcare service platform, secures nearly RMB 100 million in Series C financing

July 15th Update: Huamei Haolian Officially Announces Completion of Series C Financing. The round includes investors such as Amiba Capital, Ventech China Yintai Capital, and Fengqiao Capital, with an amount nearing 100 million yuan. The funds will primarily be used for the research and development of services and products, market promotion, and advancing the upgrade and construction of an AI-driven digital medical and healthcare service platform.

Industry Perspective：

Huamei Haolian is a one-stop artificial intelligence digital medical and health service platform. By integrating high-quality medical resources and technological empowerment, it fully empowers insurance institutions, banks, enterprises, and the medical sector in a B2B2C model, providing customers with comprehensive "pre-diagnosis, during diagnosis, post-diagnosis" life cycle, high-quality medical and health services.

UCB's New Autoimmune Drug "Bimekizumab" Approved for Marketing in China
Chipscreen Biosciences' Innovative Drug Approved for New Indication, Treating Type 2 Diabetes
Rongchang Bio "Telitacicept" Approved for New Indication, Treating Rheumatoid Arthritis
Lilly's Heavyweight New Drug "Tirzepatide" Approved for Weight Loss Indication in China
New Anti-Epileptic Drug "Ganaxolone" Approved for Marketing in China
Multiple Medical Device Products Approved for Marketing

UCB's New Autoimmune Drug "Bimekizumab" Approved for Marketing in China

On July 19, the official website of China's National Medical Products Administration (NMPA) announced that the marketing application for bimekizumab injection submitted by UCB has been approved. Public information indicates that bimekizumab is an interleukin-17A/F (IL-17A/F) inhibitor. The indication for which this product has been approved in China has not yet been disclosed.

Source:MedView

Microchip Biotech's Innovative Drug Approved for New Indication, Treating Type 2 Diabetes

On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for Chiglitazar Sodium Tablets, a PPAR full agonist developed by Chipscreen Biosciences, has been approved. According to an earlier announcement by Chipscreen Biosciences, the newly approved indication for Chiglitazar Sodium is: in combination with metformin, for the treatment of patients with type 2 diabetes whose blood glucose levels are not well controlled by metformin monotherapy.

Source:MedView

Rongchang Bio's "Telitacicept" Approved for New Indication, Treating Rheumatoid Arthritis

On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for Rongchang Bio's injectable Telitacicept (RC18) has been approved. According to a previous press release by Rongchang Bio, the approved indication is for rheumatoid arthritis (RA). This marks the second approved indication for Telitacicept, following the approval for systemic lupus erythematosus (SLE) in March 2021.

Source: Pharma Observer

Lilly's Heavyweight New Drug "Tirzepatide" Approved for Weight Loss Indication in China

On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for tirzepatide injection, submitted by Eli Lilly and Company, has been approved. According to an earlier press release from Eli Lilly, the newly approved indication for this drug is: long-term weight management in adult patients with obesity or overweight accompanied by at least one weight-related comorbidity, in conjunction with a reduced-calorie diet and increased physical activity.

Source: MEDview

New Anti-Epilepsy Drug "Ganaxolone" Approved for Marketing in China

On July 16, Tenacia Biotechnology announced that its ganaxolone oral suspension (brand name: Zeyuan An), introduced from Marinus Pharmaceuticals, has been approved for marketing in China. It is indicated for the treatment of seizures in patients aged 2 years and above with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder. This is a positive allosteric modulator targeting the GABAA receptor. The marketing application for this approval had previously been granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Source: MedView

Multiple Medical Device Products Approved for Marketing

On July 18, 2024, the official website of the National Medical Products Administration announced that it had approved the registration applications for two innovative products from Shenzhen Saihe Medical Technology Co., Ltd.: the "Portable Ultrasound Diagnostic Device" and the "Single-Use Intracardiac Ultrasound Imaging Catheter."

Source: Siyu MedTech

Recently, Transit Scientific announced that its XO Constrain angioplasty platform received FDA approval for the treatment of calcified plaques and fibrotic lesions in the peripheral vascular system.

Source: Siyu MedTech

Huadong Medicine (000963.SZ) announced that KIO015, an injectable dermal filler product under Sinclair, its wholly-owned UK subsidiary, has submitted an application for EU CE certification. The product is expected to receive EU CE certification by 2025 and is poised to become the world’s first non-animal-derived chitosan aesthetic filler.

Source: Medactive

Grency@ Iliac Vein Stent System and Peri0ne Peripheral Thrombus Aspiration Catheter, independently developed by Hangzhou Weiqiang Medical Technology Co., Ltd., have been approved for marketing by the National Medical Products Administration (NMPA).

Source of Information:Instrument Family

According to MedRobot, on July 18, 2024, the National Medical Products Administration announced the delivery information of medical device approval documents. The SR2000 laparoscopic surgical robot from Kangduo was approved on July 17 (Registration Certificate No.: 20243011275), a four-arm surgical robot.

Source: MedRobot

On July 17, 2024, Global Medical (NYSE:GMED), one of the top ten global orthopedic device companies, announced that its new Excelsius Flex orthopedic surgical robotic system for total knee arthroplasty (TKA) has received FDA 510(k) clearance in the United States.

Source: MedRobot

Tango Bio's New Class 1 Drug Submitted for Clinical Trial in China
4DMT: Positive Data from Ophthalmology Gene Therapy Announced, Phase III Clinical Trial to Launch Soon
Yimiao神州 Colorectal Cancer CAR-T Therapy IND Application Accepted
Roche's Heavyweight Bispecific Antibody Demonstrates Long-Term Efficacy
BeiGene Submits Another ADC New Drug for Clinical Trials, Targeting Lung Cancer and Other Diseases
Roche's Potential "Best-in-Class" Weight Loss Therapy Phase 2 Trial to Launch Soon
Rona Therapeutics Collaborates on Development, New Indication for Long-Acting Ophthalmic Therapy Approved for Clinical Trials
Bayer's Darolutamide Achieves Primary Endpoint in Phase III ARANOTE Trial for Metastatic Hormone-Sensitive Prostate Cancer Patients

Tangram Pharma's Novel Class 1 Drug Submitted for Clinical Trials in China

On July 20, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the clinical trial application for BRII-693 Injection, a Class 1 new drug submitted by Brii Biosciences, has been accepted. Public information indicates that this is a novel lipopeptide antibiotic. The product is being developed to treat refractory multidrug-resistant/extensively drug-resistant (MDR/XDR) Gram-negative bacterial infections. Brii Biosciences previously obtained the global exclusive development and commercialization agreement for this product through a collaboration.

Source: Pharma Observer

4DMT: Positive Data from Ophthalmology Gene Therapy Announced, Phase III Clinical Trial to Launch Soon

On July 17, 2024, leading gene drug company 4D Molecular Therapeutics announced positive preliminary 24-week data from the expansion cohort of patients in the Phase 2 clinical trial PRISM for its investigational gene therapy 4D-150. The trial evaluated the effects of intravitreal injection of 4D-150 in a broad population of patients with wet age-related macular degeneration (AMD).

Source: Frontier of Cell and Gene Therapy

Yimiao神州 Colorectal Cancer CAR-T Therapy IND Application Accepted

On July 18, Beijing Immunochina Pharmaceutical Technology Co., Ltd. announced that the Investigational New Drug (IND) application for its next-generation anti-cancer drug, IM96 Chimeric Antigen Receptor T-cell Injection (IM96 CAR-T Cell Injection), used for the treatment of metastatic colorectal cancer, has been accepted by the National Medical Products Administration.

Source: Yimaike

Roche's Heavyweight Bispecific Antibody Demonstrates Long-Term Efficacy

Roche Announces Four-Year New Data from the RHONE-X Clinical Trial of Bispecific Antibody Therapy Vabysmo (faricimab) for Diabetic Macular Edema (DME). The study met all primary endpoints, showing that Vabysmo was well-tolerated in DME patients receiving up to four years of treatment. Exploratory results from the long-term study indicated that Vabysmo continued to maintain patients' vision and extend the treatment interval for DME patients. Notably, over 90% of patients treated with Vabysmo reached the standard for DME symptom resolution after four years.

Source: WuXi AppTec

BeiGene Submits Another ADC New Drug for Clinical Trials, Targeting Lung Cancer and Other Diseases

On July 18, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the clinical trial application for BeiGene's Class 1 new drug, BGB-C354 injection, has been accepted. According to publicly available information from BeiGene, this is an antibody-drug conjugate (ADC) targeting B7-H3, intended for the development of treatments for lung cancer and head and neck squamous cell carcinoma (HNSCC).

Source:MedView

Roche's Potential "Best-in-Class" Weight Loss Therapy Phase 2 Trial to Launch Soon

Roche Reveals Detailed Results of Phase 1 Clinical Trial for CT-388, a Potential "Best-in-Class" Dual Agonist of Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide-1 (GLP-1) Receptors, in the Abstracts for the Upcoming 2024 EASD Annual Meeting

Source: WuXi AppTec

Rona Therapeutics Collaborates on Development, New Indication for Long-Acting Ophthalmic Therapy Approved for Clinical Trials

On July 15, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that a new clinical trial application for an ophthalmic treatment product, EYP-1901 intravitreal implant, co-developed by Betta Pharmaceuticals and EyePoint Pharmaceuticals, has been approved. The product is intended to treat wet (neovascular) age-related macular degeneration (wAMD) patients who have previously received anti-VEGF intravitreal injections.

Source: Pharma Observer

Bayer's Darolutamide Meets Primary Endpoint in Phase III ARANOTE Trial for Metastatic Hormone-Sensitive Prostate Cancer Patients

On July 17, 2024, the ARANOTE III Phase clinical trial studied darolutamide combined with ADT for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The trial has reached the primary endpoint of rPFS. Compared with placebo plus ADT, darolutamide plus ADT significantly increased rPFS.

Source: Arterial Network

Huadong Medicine Announces the Introduction of a Neurological Disease Drug
GC Cell&Checkpoint Collaborate to Develop New Therapy Combining Anti-PD-L1 Antibody with Autologous T Cells
Livzon Pharmaceutical and NeuShen Therapeutics Reach an Exclusive Licensing Agreement for Highly Selective KCNQ2/3 Activator NS-041 in Greater China
Vertex Invests Nearly $1 Billion in New Treatment Model
Fluence Therapeutics Grants Global Rights for a Novel Radiopharmaceutical Cancer Drug

Huadong Medicine Announces the Introduction of a Neurological Disease Drug

On July 14, Huadong Medicine and Auson Biopharm announced an exclusive strategic cooperation agreement for the development, registration, manufacturing, and commercialization of all indications of the improved new drug Edaravone oral formulation TTYP01 tablets (Edaravone tablets) in mainland China, Hong Kong, Macao, and Taiwan. According to the agreement terms, Auson Biopharm will receive an upfront payment of 100 million RMB, milestone payments for development, registration, and sales of up to 1.185 billion RMB, and tiered royalties of up to double digits on net sales.

Source: MedView

GC Cell&Checkpoint Collaborate to Develop New Therapy Combining Anti-PD-L1 Antibody with Autologous T Cells

Recently, GC Cell announced a strategic partnership with Checkpoint Therapeutics to jointly explore the potential of combining Checkpoint's cosibelimab (anti-PD-L1 antibody) with GC Cell's Immuncell-LC (autologous T-cell therapy).

Source: Yima Guest

Livzon Pharmaceutical and NeuShen Therapeutics Reach an Exclusive License Agreement for High-Selectivity KCNQ2/3 Activator NS-041 in Greater China

Recently, Livzon Pharmaceutical Group Co., Ltd., a wholly-owned subsidiary of Livzon Pharmaceutical Factory, has reached an exclusive license agreement for Greater China with NeuShen Pharma (Shanghai) Co., Ltd. regarding the small molecule candidate drug NS-041, which is globally intellectual property owned by NeuShen Pharma. Both parties will closely cooperate on this basis to accelerate the market launch process of NS-041.

Source: Yaoke News

Vertex Invests Nearly $1 Billion to Develop New Treatment Model

Orum Therapeutics Announces Global Multi-Target Research and License Agreement with Vertex Pharmaceuticals for TPD² Platform to Develop Conditioning Agents for Gene Editing Therapies

Source: WuXi AppTec

Fusion Medical Grants Global Rights for a New Radioactive Cancer Drug

On July 17, 2024, radiotherapeutics company Full-Life Technologies announced that it had signed an out-licensing agreement with biotech company SK Biopharmaceuticals. Under the agreement, Full-Life Technologies grants SK Biopharmaceuticals exclusive global rights to clinically research, develop, manufacture, and commercialize the radiopharmaceutical FL-091 for cancers positive for neurotensin receptor 1 (NTSR1).

Source: Medicilon

TAIMEI Medical Successfully Registers IPO with HKEX

After its STAR Market IPO process was halted due to rejection by the Shanghai Stock Exchange, Zhejiang Taimei Medical Technology Co., Ltd. subsequently shifted its focus to the Hong Kong Stock Exchange. More than five months after filing, the company recently received a listing record-filing notice from the China Securities Regulatory Commission for its Hong Kong Stock Exchange listing, with an issuance of no more than 135 million shares.

Source: Cailian Press

Statistical Period: July 13, 2024 - July 20, 2024

*Data source: Huaxing Capital internal organization

Market Value Date: July 19, 2024

Market Value Unit: Million USD

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*Data source: Capital IQ, prospectus, research reports, annual reports

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