China Renaissance Healthcare & Life Sciences Weekly Report Vol.331 Highlights Key Financing Activities and Innovation in Neurology, Inhaled Biologics, and Green Bio-manufacturing

Aug 05, 2024 09:30 CST Updated 09:30

Novamab

Nanobody Innovative Drug Developer

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

Healthcare and life sciences is a sector that Huaxing Capital has focused on and deeply cultivated for many years. It has served as a financial advisor for nearly 200 financing and M&A projects.

Innovation in the medical and life science technology industry continues to emerge, making it one of the most active sectors. Huaxing Capital has always supported and accompanied the growth of start-ups in this field, striving 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 Observations" - "Life Science & Technology" in the backstage to obtain more information related to the healthcare and life science & technology industries.

SINEUGENE Completes Nearly 100 Million Yuan Pre-A Financing Round

Recently, SINEUGENE (Beijing) Biotechnology Co., Ltd. successfully completed a nearly RMB 100 million Pre-A round of financing. This round was led by Zhongguancun Capital, with participation from ZHONGBU Julili, Chuanghua Capital, and Sanmei Investment. The funds raised will mainly be used for the IND application of SINEUGENE's first pipeline, SNUG01, and the advancement of other pipeline products.

Industry Perspective:

SINEUGENE, relying on over a decade of scientific research accumulation by Professor Yi-Chang Jia's team from the School of Medicine at Tsinghua University, has established platforms for novel gene knock-in animal disease models, such as fruit flies and mice, and a central nervous system adeno-associated virus (AAV) vector screening platform. It is committed to developing treatments for neurological diseases such as Amyotrophic Lateral Sclerosis (ALS, commonly known as "Lou Gehrig's disease"), stroke, and Parkinson’s disease.

Novamab Completes RMB 200 Million B2 Financing Round, Led by Qiming Venture Partners

Shanghai Novamab Biopharmaceuticals Co., Ltd., a biotechnology company dedicated to the research and development of innovative nanobody drugs, officially announced today: the successful completion of nearly 200 million RMB in B2 round financing. This round of financing was led by Qiming Venture Partners, with participation from Huangpu Biomedical Industry Fund and Jiuyu Investment. Existing shareholder Shengdi Investment continued to increase its investment. The company also announced the successful conclusion of its B-round financing, accumulating nearly 300 million RMB in funding. Previously, Novamab had completed the B1 round of financing in December 2023, led by Shengdi Investment with participation from Guosheng Capital. The proceeds from this round of financing will mainly be used to advance the clinical Phase II studies of two inhaled antibody drugs (LQ036, LQ043H) independently developed by the company based on its "Inhaled Macromolecule Drug Development Platform," while enriching the company's pipeline in the autoimmune field, strengthening the team, and further replenishing corporate working capital.

Industry Perspective:

Novamab focuses on the research and development of inhalable nanobody drugs. It has established a complete R&D, CMC, and pilot production system, built five major innovative technology platforms, and pioneered the study of fast-acting, highly specific inhalable nanobodies. It is currently the only company in China with full-process development capabilities for inhalable nanobody drugs.

Dedicated to Green Biomanufacturing, Beijing Yanwei Technology Co., Ltd. Completes Over 150 Million Yuan in Series A Financing

Recently, Beijing Yanwei Technology Co., Ltd., a bio-manufacturing enterprise, completed an A-series financing round exceeding 150 million yuan. This round was led by Tsinghua Holdings Jinxin and Yizhuang Guotou, with participation from new and existing shareholders including Sequoia China, Frees Fund, Kangyu Capital, and CDH VGC.

Industry Perspective:

Beijing Yanwei Technology Co., Ltd. is an innovative enterprise established by the transformation of synthetic biotechnology achievements from Tsinghua University. The company is committed to realizing the green bio-manufacturing of specialty chemicals and advanced materials. Since its establishment, Yanwei Technology has received tens of millions of yuan in venture capital from several international and domestic first-tier institutions.

Zhikang Hongyi Secures Hundreds of Millions in A+ Round Financing

On July 31, ZhiKang Hongyi announced the successful completion of a multi-million yuan A+ round of financing. This round of financing was led by Xichuang Investment and Binhu Industrial Group, with existing shareholders such as Wuxi Biologics continuing to increase their investment.

Industry Perspective:

ZhiKang Hongyi is currently actively advancing the clinical development of several innovative drugs with "global first-in-class, best-in-class" potential in the fields of oncology and nephrology. Among them, the core oncology product, BC3195, a globally exclusive ADC drug targeting CDH3, is conducting dose-expansion studies in multiple cohorts in Phase Ib clinical trials simultaneously in China and the United States. The core nephrology product, SC0062, a potentially best-in-class highly selective ETA small molecule antagonist, is nearing completion of the Phase II 2-SUCCEED study, and is currently in active communication with regulatory authorities to strive for initiating Phase III clinical trials within the year.

Fuxiang Medical Completes Series A Financing, Jointly Invested by Herui Ventures, Yuhai Capital, and Shaanxi New Era Capital

Recently, Fuxiang Sital Medical Technology (Suzhou) Co., Ltd. announced the completion of its Series A financing round, with investments from Herui Venture Capital, Yuhai Capital, and Shaanxi New Era Capital. The funds will be used to further increase R&D efforts, promote product launches, expand market channels, and enhance brand awareness.

Industry Perspective:

Fuxiang Medical was founded in 2020 as an innovative enterprise specializing in the research and development of silk fibroin medical materials. The company has developed various forms of silk fibroin materials, including absorbable interface screws, biodegradable silk fibroin bone nails, 3D-printed cartilage, and other consumable products, as well as biological patches and skin wound repair membranes.

RuiPai Medical Completes D-round Financing of Several Hundred Million Yuan

News on July 30: Recently, Guangzhou RuiPai Medical Device Co., Ltd., a global player in the single-use endoscope sector, announced the successful completion of a D-round financing worth hundreds of millions of yuan. This round was led by Tianxin Emerging Industry Fund under CICC Capital, with participation from Guangzhou Industrial Investment, Suzhou Trust, Qingke Capital, and Tongying Venture Capital. Existing shareholders Yuexiu Industrial Fund and Oriza Origination continued to increase their investment. The funds raised will mainly be used for the iteration of multi-mirror products and the further expansion of overseas business. After this round of financing, RuiPai Medical will continue to promote the construction of intelligent endoscopic operating rooms, providing comprehensive single-use endoscopic diagnosis and treatment solutions covering all departments for medical institutions, doctors, and patients.

Industry Perspective:

Currently, Ray-Endo Medical has obtained 20 NMPA certificates, covering seven types of endoscopes: disposable ureteroscopes, disposable rigid cystoscopes, disposable flexible cystoscopes, disposable hysteroscopes, disposable cholangioscopes, disposable gastroscopes, and disposable colonoscopes. Based on a full-department strategy, Ray-Endo Medical has simultaneously developed portable, multi-interface endoscope hosts that can meet the needs of different levels of hospitals by matching various models with multi-mode compatibility. In terms of commercialization strategy, since Ray-Endo Medical has reserved a technical upgrade iteration window for the endoscope host, hospitals that have purchased Ray-Endo Medical hosts will be able to quickly respond to the demands of new surgical procedures subsequently. This allows for one machine with multiple scopes and efficient consecutive operations, significantly reducing surgical costs and truly achieving convenient healthcare and affordable patient care.

Herci Medical, a medical injection pen company, completes hundreds of millions of yuan in financing

August 1 News: Hanerci Medical Completes Hundreds of Millions of Yuan in Series B Financing, Led by Fuzhe Fund and Co-led by Jianchuang Medical Growth Fund, with Lishui Fuchu and Herui Venture Capital participating.

Industry Perspective：

Herci's research and development in the field of pen injectors began in 2012, and in 2014, "Suzhou Herci Medical Device Development Co., Ltd." was established. In 2015, it provided the first-generation product design for Chengji Biotechnology, a subsidiary of Hanmi Pharmaceutical. After years of research and development, Herci’s new generation of products has been compared with global injection pen patents and passed the global FTO review. It has now become one of the few companies in China that owns fundamental intellectual property rights for pen injectors, and has completed the industrial transformation to automated production, supporting overseas sales for all pharmaceutical companies in China. This means that China has completely broken the overseas injection pen patent monopoly and posed a direct challenge to foreign injection pen companies.

Maike Long Completes Tens of Millions of Yuan in Pre-A Round Financing

On July 30, it was reported that Sichuan Maikelong Biotechnology Co., Ltd., an innovative high-tech enterprise focusing on microfluidic intelligent manufacturing technology, has successfully completed a Pre-A round of financing worth tens of millions of yuan. This round was jointly invested by Chengdu Science and Technology Innovation Investment Group Co., Ltd. and Sichuan Development Industrial Guidance Equity Investment Fund Management Co., Ltd. The funds will be used to accelerate the company's technological development and clinical project progress, injecting strong momentum into Maikelong's industrialization path in the field of microfluidic technology.

Industry Perspective：

As a leader in the microfluidic controllable preparation technology platform for functional microspheres, Mekelone has established several cutting-edge theories on the preparation of functional microspheres using microfluidic technology. It has innovated new strategies for confined-space fluid manipulation and developed novel methods for chip design and development. Mekelone has pioneered the use of closed and open amplification systems to create a batch production system for microspheres, successfully achieving the controllable preparation of hundreds of types of functional microspheres.

China's First Long-term Mechanism for Basic Medical Insurance Participation Officially Announced

Guiding Opinions on Improving the Long-term Mechanism for Basic Medical Insurance Enrollment Published

The World's First TCR-T Cell Therapy Approved for Marketing
Daratumumab Subcutaneous Formulation Quadruple Therapy Approved for Treatment of Newly Diagnosed Multiple Myeloma
Roche's Heavyweight Bispecific Antibody Receives EU Approval Again, Secures Third Indication
Neurodegenerative Disease Drug Developer Alpha Cognition Oral Therapy ZUNVEYL^®Approved by the FDA for the treatment of Alzheimer's disease
Long-Acting Schizophrenia Drug by Luye Pharma Approved for Marketing by U.S. FDA
SINOVAC Biotech's Albumin-Bound Paclitaxel for Injection Approved for Marketing in the EU
Multiple Medical Device Products Approved for Marketing

The World's First TCR-T Cell Therapy Approved for Marketing

Adaptimmune Therapeutics Announces Its Cell Therapy Product TECELRA^®(Afamitresgene autoleucel) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced synovial sarcoma. This is reported to be the world's first approved TCR-T cell therapy.

Source: Cell and Gene Therapy Field

Daratumumab Subcutaneous Formulation Quadruple Therapy Approved for Treatment of Newly Diagnosed Multiple Myeloma

On July 30, Johnson & Johnson announced that the FDA had approved the supplemental Biologics License Application (sBLA) for daratumumab subcutaneous injection formulation (brand name: Darzalex Faspro) for use in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) as induction and consolidation therapy for newly diagnosed multiple myeloma (NDMM) adult patients who are eligible for autologous stem cell transplantation (ASCT).

Source of Information:PharmaCube

Roche's Heavyweight Bispecific Antibody Receives EU Approval Again, Secures Third Indication

Roche announced that the European Commission (EC) has approved the bispecific antibody Vabysmo (faricimab) for the treatment of vision impairment caused by macular edema due to retinal vein occlusion (RVO). This is the third indication for Vabysmo in the EU, following previous approvals for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Source of Information:WuXi AppTec

Neurodegenerative Disease Drug Developer Alpha Cognition Oral Therapy ZUNVEYL^®Approved by the FDA for the treatment of Alzheimer's disease

Alpha Cognition (CSE:ACOG) (OTCQB:ACOGF), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has approved ZUNVEYL.^®(Benzogalantamine), formerly known as Alpha-1062, is used to treat mild to moderate Alzheimer's disease.

Source: Arterial Network

Luye Pharma's Long-Acting Schizophrenia Drug Approved by U.S. FDA for Market Launch

On July 28, Luye Pharma Group announced that its self-developed ERZOFRI^®(Paliperidone Palmitate Extended-Release Injectable Suspension) has received FDA approval for marketing in the United States under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This medication is a long-acting injectable administered once monthly for the treatment of adult patients with schizophrenia, as well as for the treatment of adult patients with schizoaffective disorder either as monotherapy or as an adjunct to mood stabilizers or antidepressants.

Source: MEDVIEW

Sinovac Biotech's Albumin-Bound Paclitaxel for Injection Approved for Marketing in the EU

On July 28, Kexing Biopharmaceuticals announced that the injectable paclitaxel (albumin-bound) (Apexelsin), introduced from HaiChuang Bio, received marketing approval from the European Commission.

Source: PharmaCube

Multiple Medical Device Products Approved for Marketing

On August 1, 2024, the National Medical Products Administration announced the delivery information of medical device approval documents. It showed that on July 30, the domestically自主研发的锟铻^®Total Orthopedic Surgery Robot Receives NMPA Approval for Unicompartmental Knee Arthroplasty, Fully Upgraded with Three-in-One Surgical Procedure (Product Name: Joint Replacement Surgical Navigation and Positioning System, Registration Certificate No.: National Medical Device Approval 20223010510).

Source: Medical Device Innovation Network

Huaxi Biotechnology Co., Ltd.'s "Sodium Hyaluronate Injectable Composite Solution" has been successfully approved for marketing by NMPA, with the registration certificate number: National Medical Device Approval No. 20243131359. The product is mainly used for correcting neck wrinkles.

Source: Medactive

Recently, Endovastec (688016.SH) released a voluntary disclosure announcement regarding the obtainment of a medical device registration certificate, stating that its developed L-REBOA...^®Aortic Occlusion Balloon Catheter (NMPA Approval No. 20243031326) Approved for Marketing by the National Medical Products Administration (NMPA).

Source: Siyu MedTech

Siemens Healthineers Varian Announces FDA 510(k) Clearance for IntelliBlate Microwave Ablation System

Source of Information:Instrument Family

On July 30, the National Medical Products Administration approved the innovative product registration application for the "Bioabsorbable Rapamycin-Eluting Coronary Stent System" by Shanghai MicroPort Medical (Group) Co., Ltd.

Source: Medical Device Innovation Network

Recently, AEYE Health, a leading company in the field of artificial intelligence retinal imaging and diagnosis, announced that its world's first fully automatic artificial intelligence system (AEYE-DS) for portable diabetic retinopathy screening has received FDA approval.

Source: Siyu MedTech

Lilly's New Drug "Tirzepatide" Shows Positive Phase 3 Trial Results, Holds Promise for Treating Heart Failure
AstraZeneca's Long-Acting Antibody Therapy Initiates Phase 3 Clinical Trials in China
Roche's Bispecific Antibody Class 1 New Drug Approved for Clinical Trials in China
PM Biosciences' Bispecific Antibody Innovative Drug for "King of Cancers" Approved for Clinical Trials
Positive Results from Phase II Study of CD47 Inhibitor as Second-Line Treatment for HER2+ Gastric Cancer
FDA Approves In Vivo Manufactured CAR-T Therapy for Human Clinical Trials
BioNTech's Tumor Vaccine Combined with PD-1 Monoclonal Antibody Phase II Study Meets Primary Endpoint
100% of Patients' Tumors Completely Disappeared, GSK's New Anti-PD-1 Monoclonal Antibody Drug Approved for Clinical Trials in China

Lilly's New Drug "Tirzepatide" Shows Positive Phase 3 Trial Results, Promising for Heart Failure Treatment

Eli Lilly and Company announced positive topline results from the SUMMIT Phase 3 clinical trial. Analysis showed that the trial met its primary endpoint, with tirzepatide injection reducing the risk of heart failure-related events by 38% in patients with obesity and heart failure with preserved ejection fraction (HFpEF) compared to placebo.

Source: MEDview

AstraZeneca's Long-Acting Antibody Therapy Initiates Phase 3 Clinical Trial in China

China Drug Clinical Trial Registration and Information Disclosure Platform recently announced that AstraZeneca and its subsidiary Alexion, which focuses on rare diseases, have initiated a Phase 3 clinical study in China. This study aims to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Ravulizumab injection in Chinese adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are naïve to complement inhibitors.

Source: MEDview

Roche's Bispecific Antibody Class 1 New Drug Approved for Clinical Trials in China

On August 2, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced that Roche's submission for the innovative drug englumafusp alfa injection had received tacit approval for clinical trials. The drug is intended to be developed for the treatment of non-Hodgkin lymphoma (NHL). Public information indicates that englumafusp alfa (RG6076) is a bispecific antibody fusion protein targeting CD19 and 4-1BB, acting as a co-stimulator for NK cells and T cells. The product is currently undergoing Phase 1 clinical trials internationally.

Source: MEDview

Pumis Biologics' Bispecific Antibody Innovative Drug Approved for Clinical Trials Targeting "King of Cancers"

On July 31, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that PM1032 Injection from Primus Bio has received tacit approval for clinical trials. It is intended to be used in combination with chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer. Public information indicates that PM1032 is a bispecific antibody targeting CLDN18.2 and 4-1BB.

Source: Medicinal Observer

Positive Results from Phase II Study of CD47 Inhibitor as Second-Line Treatment for HER2+ Gastric Cancer

On July 31, ALX Oncology announced positive results from the Phase II ASPEN-06 study of its investigational CD47 inhibitor evorpacept in HER2-positive advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJ) patients who had previously received anti-HER2 therapy.

Source of Information:PharmaCube

FDA Approves In-Body Manufacture of CAR-T Therapy for Human Clinical Trials

Umoja Biopharma Announces FDA Approval of IND Application for UB-VV111, an In-Situ Generated CD19-Targeted CAR-T Cell Therapy, for the Treatment of Hematologic Malignancies

Source: WuXi AppTec

BioNTech's Tumor Vaccine Combined with PD-1 Monoclonal Antibody Phase II Study Meets Primary Endpoint

On July 30, BioNTech announced that the Phase II clinical trial (NCT04526899) of its investigational tumor vaccine BNT111 in combination with Regeneron's PD-1 monoclonal antibody Libtayo (cemiplimab) had met the primary efficacy endpoint.

Source: PharmaCube

100% of Patients' Tumors Completely Disappeared, GSK's Anti-PD-1 Monoclonal Antibody New Drug Approved for Clinical Trials in China

On July 29, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) announced that the dostarlimab injection, submitted by GlaxoSmithKline (GSK), has received tacit approval for clinical trials in China. It is intended to be developed for the treatment of adult patients with locally advanced, previously untreated mismatch repair-deficient (dMMR)/high microsatellite instability (MSI-H) rectal cancer. Public information shows that dostarlimab is an anti-PD-1 antibody, which has already been approved by the U.S. FDA for multiple anti-tumor indications. This marks the first time the product has been approved for clinical trials in China.

Source: MEDVIEW

Over $2 Billion: I-Mab Biopharma Reaches Licensing Agreement for Two Innovative Cancer Drugs
Over 1.1 Billion Yuan: Mabwell Introduces an Oral Innovative Drug for Osteoarthritis Treatment
Over $400 Million to Develop Potential "First-in-Class" Bispecific ADC Cancer Therapy, New Agreement Reached
GenScript Biotech and Porton Biologics Reach Cooperation to Jointly Advance circRNA Innovative Therapies
CanSinoBio Achieves Multiple Collaborations Including Overseas mRNA Multivalent Flu Vaccine

Over $2 Billion: Immxun Co. Reaches Licensing Agreement for Two Innovative Cancer Drugs

On August 1, Immgene just announced an agreement with Instil Bio. According to the agreement, Instil will obtain the development and commercialization rights outside Greater China for Immgene's proprietary PD-L1xVEGF bispecific antibody IMM2510 and next-generation CTLA-4 antibody IMM27M. Under the terms of the agreement, SynBioTx, a wholly-owned subsidiary of Instil, will gain global development and commercialization rights for IMM2510 and IMM27M outside Greater China, while Immgene will retain the development and commercialization rights in Greater China (including Taiwan, Macao, and Hong Kong). Immgene will receive an upfront payment of up to 50 million US dollars and potential near-term payments, and is expected to receive milestone payments totaling over 2 billion US dollars upon achieving several development, regulatory, and commercial milestones, as well as royalties in the single-digit to low double-digit percentage range based on net sales globally (excluding Greater China).

Source: Medicinal Observer

Over 1.1 Billion Yuan: Mabwell Introduces an Oral Innovative Drug for Osteoarthritis Treatment

On August 2, Mabwell announced that its wholly-owned subsidiary Taikang Biologics had entered into a licensing agreement with Runjie Pharmaceuticals. Under the agreement, Runjie Pharmaceuticals grants Taikang Biologics the rights to research, develop, register, commercialize, and sell the RP901 project and its companion diagnostics (developed solely for use with the licensed product) within Greater China (including mainland China, Hong Kong, Macao, and Taiwan). According to the agreement, Runjie Pharmaceuticals will receive an upfront payment of RMB 50 million, potential development and registration milestone payments, as well as commercial milestone payments totaling up to RMB 1.07 billion, and royalties of up to 10% of net sales.

Source: MEDtime

Over $400 Million to Develop Potential "First-in-Class" Bispecific ADC Cancer Therapy, Newcomer Reaches Agreement

IDEAYA Biosciences Announces Agreement with Biocytogen Pharmaceuticals for Potential Deal Worth Over $400 Million – IDEAYA Granted Global Exclusive License Option for Biocytogen's Potential "First-in-Class" Bispecific Antibody-Drug Conjugate (BsADC) Therapy.

Source: WuXi AppTec

GenScript Biotech and BioRay Biotech Collaborate to Advance circRNA Innovative Therapies

On July 29, 2024, Guangzhou Genesea Biotech Co., Ltd. announced a strategic partnership with Suzhou Porton BioPharma Co., Ltd. Leveraging their respective strengths in the gene therapy field, the two parties will collaborate closely to enhance drug development services. Genesea Biotech possesses comprehensive core patented technologies in circRNA drug proof-of-concept and process development. Combined with Porton BioPharma’s end-to-end gene and cell therapy service platform and resource advantages, the collaboration aims to advance technological innovation and clinical translation, accelerating the implementation of innovative circRNA therapies.

Source: Frontier of Cell and Gene Therapy

CanSinoBio Achieves Multiple Collaborations Including Overseas mRNA Multivalent Flu Vaccine

Recently, CanSino Biologics and the National Institute of Biotechnology in Malaysia (NIBM), representing China and Malaysia respectively, signed a cooperation agreement, marking a new phase of long-term, extensive, and deepened collaboration in the vaccine field. According to the agreement, CanSino Biologics and NIBM will engage in in-depth cooperation on the development, manufacturing, technology transfer, and talent exchange of innovative products such as mRNA multivalent influenza vaccines.

Source: Frontier of Cell and Gene Therapy

Tongyuan Kang Medicine Goes Public in Hong Kong, Expected to Continue Losses in 2024

On July 29, Zhejiang Tongyuan Kang Pharmaceutical Co., Ltd. submitted an application for listing on the Hong Kong Stock Exchange Main Board, with CITIC Securities as the sole sponsor.

Source: CNR Network

Statistical Period: July 26, 2024 - August 2, 2024

*Data source: Huaxing Capital internal organization

Market Value Date: August 2, 2024

Market Value Unit: Million USD

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*Data Sources: Capital IQ, Prospectus, Research Reports, Annual Reports

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