Zhangjiang Pharma Valley Monthly Report | March: 11 Financings, 5 BD Deals, and Global Launch of 'Zhangjiang-made' Brain-Computer Interface Product
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
As a core area carrying national strategic missions, Pudong shoulders the important task of building a world-class biopharmaceutical industry cluster, and is accelerating the construction of "the global launching site for innovative drugs and medical devices, the preferred destination for scientists to start businesses, and the birthplace of institutional reforms."
As a landmark of Pudong's biopharmaceutical industry, the influence of the "Zhangjiang Medipark" brand continues to grow. The Medipark Journal launches a regular column, "Zhangjiang Medipark Monthly Report," each month, focusing on innovative achievements, initiatives, and services. It promotes the continuous emergence of "3F" innovative achievements: "Global First-in-Class, China First-in-China, and Clinical First-in-Human."
Policy Dynamics
● The Center for Medical Device Standards Management of the National Medical Products Administration released the "Guiding Principles for the Classification of Medical Device Products Using Brain-Computer Interface Technology (Draft for Comments)" and the "Guiding Principles for the General Naming of Medical Devices Using Brain-Computer Interface Technology (Draft for Comments)."
On March 19, according to the requirements of the National Medical Products Administration (NMPA),National Medical Products AdministrationThe Medical Device Standard Management Center organized the drafting of"Guiding Principles for the Classification of Medical Device Products Using Brain-Computer Interface Technology (Draft for Comments)" "Guiding Principles for the General Name Nomenclature of Medical Devices Using Brain-Computer Interface Technology (Draft for Comments)", Open for public comments.
●NMPA Formulates the "Guiding Opinions on the Standardization of Modern Medicine Logistics"
On March 20, to implement the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53) and the "Administrative Measures for the Quality Supervision of Drug Operation and Use," to promote the orderly and efficient development of standardized modern logistics construction by drug wholesale enterprises and third-party drug logistics enterprises, further standardize the access of drug wholesale enterprises, and continuously improve the quality management level in drug distribution, the National Medical Products Administration organized the formulation.Guidelines for the Standardized Construction of Modern Pharmaceutical Logistics。
Major Discovery
● And誉医药 CSF-1R Highly Selective Small Molecule Inhibitor Beijiema® Global Phase III Study Published in The Lancet, Gains Recognition from Top International Journal
European time, March 5th,Abbisko TherapeuticsHansoh Pharma announced that the results of the global multicenter Phase III MANEUVER study of its self-developed highly selective CSF-1R small molecule inhibitor, pimicotinib hydrochloride capsules (brand name: Beijiema®), have been officially published in the internationally renowned medical journal, The Lancet.The Lancet). The publication of this paper marks a new level for Abbisko Therapeutics in terms of the quality of clinical research, data integrity, and international academic recognition.
● Hansoh Pharma's B7-H3-targeted ADC Drug Risvutatug Rezetecan: First-in-Human Phase Ⅰa/b Study Results inCancer CellPublish
March 6,Hansoh PharmaAnnounce the results of a Phase Ia/b study (ARTEMIS-001 study, NCT05276609) evaluating Risvutatug rezetecan (research code: HS-20093/GSK5764227), an ADC drug targeting B7-H3 independently developed by Hansoh Pharma, in previously treated patients with advanced solid tumors, published in the form of a research paper.Cancer CellOfficially published. The research results showed that: the drug demonstrated clinically meaningful anti-tumor activity in lung cancer patients who had undergone multiple previous lines of treatment.
● Phase I Clinical Trial Results of HBM9378, the First-in-Human Study by Harbour BioMed, Published Online in Peer-Reviewed Journal
March 23,Harbour BioMedHBM9378 (SKB378 or WIN378) Phase I Clinical Trial Results Published in Peer-Reviewed JournalDrug Design, Development and TherapyThe favorable safety profile and extended half-life characteristics observed in this study provide support for further evaluation of the therapy's efficacy in severe immunological diseases.
● Hengrui's Innovative Drug Camrelizumab Significantly Improves Survival Rate of High-Risk Nasopharyngeal Cancer Patients; Research Published in Top International Journal
March,Hengrui MedicinePhase III Clinical Research Results of Innovative Drug PD-1 Inhibitor Camrelizumab in High-Risk Locally Advanced Nasopharyngeal Carcinoma Published in The BMJ. The study confirmed that the combination of camrelizumab with standard concurrent chemoradiotherapy followed by sequential adjuvant therapy significantly improved progression-free survival in patients with high-risk locally advanced nasopharyngeal carcinoma, offering new treatment hope for these high-risk patients.
● Fudan University's latest research published in NEJM, first confirms that preoperative neoadjuvant therapy reduces mortality risk by 57% in high-risk intrahepatic cholangiocarcinoma
In March, a significant research achievement led by the team of Academician Fan Jia, Academician Zhou Jian, and Professor Shi Guoming from Fudai University-affiliated Zhongshan Hospital, in collaboration with 11 top medical centers in China, was published online in The New England Journal of Medicine (NEJM). The study is the first to confirm through a randomized controlled trial that for patients with resectable intrahepatic cholangiocarcinoma at high risk of recurrence, the preoperative use of the "GOLP" regimen (gemcitabine plus oxaliplatin chemotherapy, combined with the targeted drug lenvatinib andJunshi BiosciencesNeoadjuvant treatment with the self-developed PD-1 inhibitor Toripalimab significantly extended patients' event-free survival, increasing the median event-free survival from 8.7 months in the control group to 18.0 months, prolonging it by nearly 10 months.
Listing Progress
● BrainLink Implantable Brain-Computer Interface Hand Movement Function Compensation System Innovative Product Approved for Marketing by NMPA
On March 13, the National Medical Products Administration (NMPA) approvedBrainRoboticsInnovative Product Registration Application for Implantable Brain-Computer Interface Hand Motor Function Compensation System Achieves World's First Market Launch of a Brain-Computer Interface Medical Device, Marking the Entry of the World’s First Invasive Brain-Computer Interface Medical Device into Clinical Application.
● Innovein Medical's Transcatheter Mitral Valve Clip System Innovative Product Approved for Marketing by NMPA
On March 24, the National Medical Products Administration (NMPA) approvedYingmai MedicalTranscatheter Mitral Valve Clip System: Innovative Product Registration Application. The product consists of a mitral valve clip and catheter delivery system, as well as a steerable guiding catheter.
Capital Dynamics - IPO Dynamics
●Bailin科 completes A-share STAR Market IPO coaching registration
March 8,BailincoCompleted the registration for IPO tutoring on China's A-share STAR Market, with CITIC Securities Co., Ltd. as the tutoring institution.
● BioRay Biotech IPO Successfully Approved, to be Listed on the Beijing Stock Exchange
March 31,BiointronThe initial public offering application has been approved by the Beijing Stock Exchange and will be listed on the Beijing Stock Exchange. It is reported that Biointron Biotech plans to invest 490.8 million yuan of the raised funds, mainly for the upgrade project of the Shanghai R&D Center and the construction project of the Jiangsu production base.
●Mabwell Bio冲刺港交所
March,MabwellFiled a prospectus with the Hong Kong Stock Exchange for a proposed listing on the Main Board of Hong Kong. CITIC Securities and Haitong International are the joint sponsors.
Capital Dynamics - Financing Dynamics
● Accura Bio Completes Over RMB 100 Million in Series A3 Financing
March 9,Aikai BioAnnounced the completion of an over RMB 100 million Series A3 financing round. This round was jointly led by Woje Capital and Zhiyi Investment, with Lianxin Capital continuing to increase its investment.
● Mabon Biotech Completes Over 100 Million Yuan in B+ Round Industrial and Strategic Financing
March 9,Maibang BioAnnounced the completion of a Series B+ round of industry and strategic financing exceeding RMB 100 million. This round of financing was led by Nanjing Xingu Group, with follow-up investment from the Huatai Jinsirui Fund under Huatai Zijin.
●Hectech Intelligence Completes RMB 50 Million in New Round of Financing
March 9,HET Carbon IntelligenceAnnounced the completion of a new round of financing worth 50 million yuan. This round of financing was led by Yonghua Investment, with Weihaocreate and individual investors following the investment, and existing shareholder Yunqi Capital continuing to support.
● Ladder Medical Completes 500 Million Yuan Strategic Financing
March 13,Tiered HealthcareAnnounced the completion of a 500 million yuan strategic financing round, and large-scale pivotal clinical trials will be initiated within the year. This round of financing was led by Alibaba, with SDIC Innovation following; existing shareholders Tencent, Origin Capital, Orbimed, Yuanhe Origination, Qiming Venture Partners, Lilly Asia Ventures, Source Code Capital, and Shanghai SDIC Pioneer also continued to participate.
● Wab Medical Completes Major Equity Financing and Debt Restructuring
March 18,WabimedAnnounced the successful completion of a major round of equity financing and debt restructuring, further solidifying the company's financial foundation. 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 as a follow-up investor.
● Tianyikang Pharmaceuticals Completes Over 100 Million Yuan in Seed Financing
March 19,Tianyikang PharmaceuticalAnnounced the completion of a seed funding round exceeding 100 million yuan. This round of financing was jointly led by Hony Capital and Mifang Health Fund, with participation from Suzhou Venture Capital, Chengshu Investment, Yingxian Investment, and Yida Capital.
● Seal Code Biotech Completes Pre-A Round Financing Worth Tens of Millions of Yuan
March 24,Zhuàn Code BioAnnounced the completion of a Pre-A round of financing worth tens of millions of yuan. This round of financing was jointly participated by Zeyue Venture Capital, Yifeng Zhuohua Fund, and Mifang Health Fund.
● Aoi Technology Completes C1 Round of Financing
March 25,AOYI TechAnnounced the completion of the C1 round of financing, which was led by the Shenzhen Brain Science and Brain-inspired Intelligence Industry Investment Fund under CICC Capital, with several existing shareholders continuing to invest.
●FengTai Pharmaceuticals Completes $89 Million Series B Financing
March 26,Fengtide PharmaAnnounced the completion of an $89 million Series B financing round, which was oversubscribed. This round was co-led by LAV and Foresite Capital, with participation from Quan Capital, HLC, RA Capital Management, Logos Capital, as well as existing investors Orbimed and Qiming Venture Partners.
● MetaNovas Successfully Completes A+ and A++ Rounds of Financing
March,MetaNovas (Yuanxin Zhiyao Technology)Announced the completion of A+ and A++ rounds of financing in succession. This round of financing was jointly invested by industry leaders such as Mommy Kangaroo Group and OEM Yayan Group, together with top financial institutions focusing on AI and deep technology, including GRC SinoGreen Fund and Hillhouse Capital.
● ImmuneOnco Biopharmaceuticals Completes Nearly 200 Million Yuan Pre-IPO Financing Round
March,Immunocore BioAnnounced the completion of a nearly 200 million yuan Pre-IPO round of financing. This round of financing was led by Gaorong Capital and Jiyuan Capital, with participation from Shenzhen Angel Investment and Mingdao Investment, and continued investment from existing shareholder Yueyin Capital.
Pharmaceutical Transactions
● Aikang Bafu and Qilu Pharmaceutical Reach Commercial Cooperation on Aizhida®
March 3,Ark BiopharmaceuticalAnnounced the official establishment of a commercial partnership with Qilu Pharmaceutical. Both parties will collaborate to advance the commercialization of Aizhida® (Compound Lisdexamfetamine Dimesylate Capsules) in China, providing better treatment options for Chinese patients with Attention Deficit Hyperactivity Disorder (ADHD). Under the agreement, Qilu Pharmaceutical will obtain exclusive commercial rights to Aikang Bifeng's new ADHD treatment drug Aizhida® in mainland China (excluding Hong Kong, Macau, and Taiwan regions). Aikang Bifeng will receive milestone payments of up to 470 million yuan, in addition to royalties based on future net sales.
● Antengene Licenses Global Rights of CD3/CD19 Bispecific Antibody ATG-201 to UCB
March 4,Dexi MedicalMedicineAnnouncement: Global rights of CD3/CD19 bispecific antibody ATG-201 licensed to UCB, which will pay $60 million upfront, $20 million in near-term milestone payments, up to $1.1 billion in milestone payments, and a certain percentage of sales royalties.
● Sanofi and China Biologic Products' subsidiary, Zhengda Tianqing, sign exclusive licensing agreement for JAK/ROCK dual-target inhibitor Rovatini.
On March 4, China Biologic Products andSanofiOfficially Reached a Heavyweight Collaboration: Exclusive Licensing Agreement Signed for the World’s First JAK/ROCK Dual-Target Inhibitor, Rovatitinib. According to the agreement, China Biologic Products’ subsidiary, Chia Tai Tianqing, will grant Sanofi the exclusive global license for the development, production, and commercialization of Rovatitinib. China Biologic Products will receive an upfront payment of $135 million, with potential additional payments tied to development, regulatory, and sales milestones, bringing the total potential earnings to up to $1.53 billion. Additionally, based on the annual net sales of Rovatitinib, it will also enjoy tiered royalties at a maximum double-digit rate.
● Libang Pharmaceuticals and R1 Therapeutics Sign Licensing and Equity Agreement for AP306
March 17,Libang PharmaceuticalsAnnounced the signing of a licensing and equity agreement with R1 Therapeutics. Under the agreement, LaboPharm has granted R1 Therapeutics exclusive rights to develop, manufacture, and commercialize AP306 in regions outside Greater China. As part of this transaction, the overall financial terms under the agreement include development, registration, and commercialization milestone payments totaling up to hundreds of millions of US dollars. Additionally, LaboPharm will receive tiered royalties based on a low double-digit percentage of net sales.
● Insilico Medicine Announces Out-Licensing and Global R&D Collaboration with Eli Lilly
March 30,Insilico MedicineAnnounced a drug discovery collaboration with Eli Lilly. This collaboration will leverage Insilico Medicine's AI engine to accelerate the discovery and development of novel therapies across multiple therapeutic areas. Under the terms of the agreement, Insilico Medicine is eligible to receive an upfront payment of $115 million and additional payments upon achieving development, regulatory, and commercial milestones, bringing the total potential value of the deal to approximately $2.75 billion. In addition, Insilico Medicine will also receive tiered royalties based on future sales.
(Edited by the Yaogu Jun team)