Zhangjiang Innovation Pharma & MedTech Monthly Report – November: Multiple 'First-in-Class' Products Approved Domestically and Internationally
HeartCare
Neurointerventional Medical Device Developer
Group after group of dreamers with aspirations for new drugs, armed with ideas and experience, have stepped out from research institutes and large multinational platforms to start from scratch in Zhangjiang Pharm Valley. Relying on "innovation," they have warmed up the once cold bench of China's innovative drug market. Zhangjiang Pharm Valley has turned China's innovative drug dreams into reality.
As a companion on the dream-chasing journey of pharmaceutical entrepreneurs, Yaogu Jun launches a new feature every month."Industry Monthly Report"Fixed Column: Together with everyone, we look back at the hot developments in the life health industry and Zhangjiang Medipark enterprises over the past month, witnessing every step of their growth.
Policy Orientation
● "Regulations on Affixing Chinese Labels to Imported Medical Devices in the China (Shanghai) Pilot Free Trade Zone (Trial)" Issued
On November 11, the Shanghai Municipal Drug Administration issued the "Regulations on Affixing Chinese Labels to Imported Medical Devices in the China (Shanghai) Pilot Free Trade Zone (Trial)" (hereinafter referred to as the "Regulations (Trial)"). The Regulations (Trial) contain eighteen articles, covering designated purposes, target entities, supervision and management, and other aspects. For imported medical devices in the Shanghai FTZ, where the domestic agent designated by the overseas registrant or filer is located within the Shanghai FTZ, the act of the domestic agent affixing Chinese labels and providing Chinese instructions within the special customs supervision area shall be implemented in accordance with the Regulations (Trial).
● Six Foreign-Invested Enterprises in Zhangjiang Complete Business Scope Changes on Their Business Licenses
On November 14, at the Zhangjiang Science City Administrative Service Center in Shanghai, six foreign-invested enterprises, including Merck Testing (Shanghai) Co., Ltd., successfully completed the change of business scope on their business licenses. From this point forward, these six foreign-invested enterprises can officially commence operations related to cell and gene therapy within the Shanghai Free Trade Zone. Additionally, two more companies have confirmed plans to establish new foreign-invested enterprises within the Zhangjiang area of the Shanghai Free Trade Zone to engage in cell and gene therapy businesses.
● Shanghai 2024 "Science and Technology Innovation Action Plan" Cell and Gene Therapy Special Project, Synthetic Biology Field Project Approval
On November 26, the Shanghai Science and Technology Commission announced the approval of projects under the 2024 "Science and Technology Innovation Action Plan" for cell and gene therapy, as well as synthetic biology. A total of 29 projects, including "Identification of Hepatocellular Carcinoma Treatment Targets Based on Omics Strategies and Development of Innovative Cell Therapies," have been approved. The Shanghai Science and Technology Commission will provide funding of 47.8 million yuan, with 38.24 million yuan allocated in 2024. Additionally, 16 projects, such as "Development of Novel CRISPR Technologies and Their Application in Chassis Strains," have also been approved, with funding of 37 million yuan, including 29.6 million yuan to be disbursed in 2024.
Major Progress
November 2,HeartCareAnnounced that the innovative product registration application for the "Great Wall Aneurysm Embolization Assist Stent" has been approved by the NMPA, becoming the first domestically produced aneurysm embolization assist stent to be approved for marketing in China.
November 4,EscugenEscugen announced that ESG401, a recombinant humanized anti-Trop2 monoclonal antibody-SN38 conjugate, has been granted Breakthrough Therapy Designation by the CDE for unresectable locally advanced, recurrent, or metastatic PD-L1-negative triple-negative breast cancer that has not been previously treated with systemic therapy.
November 4,NuoSheng MedicalAnnounced that the Nosheng Composite Steep Pulse Treatment Device HFMP-01E has received CE approval for marketing, and the portable devices Nosheng Aieryi® PCa & Nosheng Aieryi® BPH have received NMPA approval for marketing.
November 5,Bioray PharmaceuticalNew Indication for EGFR Inhibitor Rezivertinib Mesylate Capsules Approved by NMPA.
November 5,PfizerAnnounced that Tazenar® (Talazoparib Tosylate Capsules) has been approved for marketing by the NMPA, in combination with Enzalutamide, for adult patients with metastatic castration-resistant prostate cancer harboring HRR gene mutations.
November 6,AmgenAnnounced that Tefoni® (Avacopan Capsules) has been approved by NMPA for marketing in China, indicated as an adjunctive treatment for adult patients with severe, active anti-neutrophil cytoplasmic antibody-associated vasculitis under standard treatment containing glucocorticoids.
November 8,Karl StorzAnnounce that the domestically produced IMAGE1 S imaging platform has been approved for marketing.
November 10,Shanghai MicroPort®China’s First Fully Implantable Cochlear Implant Prototype, Jointly Developed with Shanghai Ninth People's Hospital, Made Its Debut at the Jointly Hosted "Fully Implantable Cochlear Implant Technology Seminar."
November 11th,Zai LabAnnounced that the supplemental biologics license application for Weilijia® (Efgartigimod Subcutaneous Injection) has been approved by the NMPA for the treatment of adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), becoming the first and currently the only drug approved for the CIDP indication in China.
November 16,Junshi BiosciencesIt was announced that its independently developed PD-1 monoclonal antibody drug, Toripalimab, has been approved for marketing in the UK and Jordan. In the UK, it was approved for two indications: first-line treatment of adult patients with recurrent, inoperable or radiotherapy-ineligible, or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine; and first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma in combination with cisplatin and paclitaxel.
November 18,3SBioThe marketing application for the self-developed recombinant anti-IL-17A humanized monoclonal antibody injection 608 has been accepted by the NMPA for the treatment of adult patients with moderate to severe plaque psoriasis.
November 19,Everest MedicinesAnnounced that Nefukang® has been fully approved for marketing in South Korea, for the treatment of adult patients with primary immunoglobulin A nephropathy.
November 21,Innovent BiologicsAnnounced that IN10018 has been designated as a breakthrough therapy by the CDE for the indication of combination treatment with the KRASG12C inhibitor garsorasib in first-line patients with locally advanced or metastatic non-small cell lung cancer positive for the KRASG12C mutation.
November 22,Blood霁 BioShanghai HeartCare Medical Technology Co., Ltd. announced that its self-developed cell therapy product XJ-MK-002 has been granted Pediatric Rare Disease Designation by the FDA for the treatment of Glanzmann's Thrombasthenia.
November 22,HutchmedAnnounce that following the pricing approval of FRUZAQLA® (fruquintinib) 1mg/5mg capsules in Japan, their partner Takeda has successfully commercially launched FRUZAQLA® in Japan for the treatment of patients with previously treated metastatic colorectal cancer. Fruquintinib is the first oral innovative targeted therapy approved in Japan for the treatment of metastatic colorectal cancer in over a decade.
November 27,Zedman PharmaceuticalsZelimir® (Benvitimod) Cream has been approved for marketing through the NMPA's priority review and approval process, becoming the world's first approved aromatic hydrocarbon receptor modulator for the treatment of atopic dermatitis in children over 2 years old and adults.
November 27,Fosun PharmaNew Indication for Injectable Botulinum Toxin Type A Approved by NMPA for the Treatment of Cervical Dystonia.
November 27,Hansoh PharmaAnnounced that the fifth NDA application for Amelo® (Aumolertinib Mesylate Tablets) has been accepted by the NMPA, for use in combination with pemetrexed and platinum-based chemotherapy drugs as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations.
November 27,BeiGeneAnnounced that BeiGene's百泽安® (Tislelizumab) has been approved by the EC for first-line treatment in combination with chemotherapy for patients with esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.
On November 28, the National Healthcare Security Administration issued the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2024)," which will be officially implemented starting January 1, 2025. Multiple drugs and indications from Zhangjiang have been included, including:BeiGeneTislelizumab,Bioray PharmaceuticalRizetinib Mesylate Capsules,AntengeneXevio®,Dizhe PharmaceuticalsShuwuzhe®,Hansoh PharmaAmeile®,HutchmedVolitinib®,Hengrui MedicineAisute®,Junshi BiosciencesTorip® by Junshi Biosciences, Kaitanis® by Akeso Biopharma, Keluping® by Keytherapeutics, Taixinzan® by Luoxin Pharma,Everest MedicinesNefukang®,Zelgen PharmaRecombinant Human Thrombin, etc.
November,InnoLead® HeartCare MedicalChina's First Self-Developed Whole-Body MRI-Compatible Pacemaker Lead BonaFire® Approved for Marketing by NMPA.
November,ShenTong MedicalHeartCare's NUMEN® Coil Embolization System, NUMEN® FR Detachment Controller, NeuroHawk® Intracranial Thrombectomy Stent, and X-track® Intracranial Distal Catheter have been approved for registration in Mexico.
November,HeartFlow MedicalChina's Self-Developed Second-Generation Transcatheter Aortic Valve Implantation Product VitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System Approved for Marketing in South Korea.
November,Minimally Invasive ElectrophysiologyThe exclusive agent's Genesis RMN® Cardiac Electrophysiology Robotic Magnetic Navigation System has been approved for marketing by NMPA.
Project Progress
1January 6,Shanghai Zhangjiang Yidian Tong & Guoyan TestingThe "Undergraduate and Graduate Medical-Engineering Transformation and Detection Practice Education Base" with Shanghai University of Science and Technology officially unveiled.
On November 7, Shanghai Jiao Tong University andShanghai PharmaceuticalsStrategic Cooperation Signing and Unveiling Ceremony of the National Key Laboratory of Innovative Immunotherapy in ChinaShanghai Biomedical Industry Frontier Innovation CenterHeld.
November 8,Shanghai Zhangjiang Institute of Medical Innovation, Baoteng BiotechnologyUnitedShanghai University of Traditional Chinese MedicineThe "TCM Microecology Medical Innovation Center" jointly built has been officially established at Shanghai University of Traditional Chinese Medicine.
November 12,ForceSoundThe training base for the adjustment and maintenance of cochlear implants and hearing aids has been officially put into use.
Honors
November 4th-7th, the 15th World Antibody-Drug Conjugate Conference was officially held.DualityBioAwarded "Best New Drug Development Enterprise" (Best New Drug Developer) Champion.
On November 6, at the EHS Management Annual Conference of the Pharmaceutical Industry,BioDuro-SundiaZhangjiang EHS Team Awarded Two EHS Management Excellence Case Awards
On November 10-11, the final round of the Second World Scientific Intelligence Competition was officially held.Shanghai Institute of Materia MedicaZhang Wei's team won the championship in the material science track.
November 13,Hengrui Pharma, Akeso BioRanked on the "2024 Forbes China Top 50 Innovative Enterprises".
November 14-16, 2024, the "16th China Pharmaceutical Entrepreneurs, Scientists, and Investors Conference" was officially held.HutchmedAwarded "Top 100 Innovative Pharmaceutical Enterprises in China 2024" and four other major awards,AbbiskoAwarded "Top 100 Innovative Pharmaceutical Enterprises in China 2024" and two other major awards.
November 14-17, 2024: The Chinese Congress of Integrative Oncology officially held.Fosun PharmaAwarded "2024 Science Popularization Benefit Demonstration Unit".
On November 17, as an important part of the 2024 China Pharmaceutical Industry Development Conference and Shanghai International Biomedical Industry Week,Zhangjiang Collaborative New Quality Development ForumHeld at Zhangjiang Science Hall,"Zhangjiang Life Science and Health Industry Annual Rising Star/Enterprise • 2024"The list was announced, with 10 enterprises and 8 representatives awarded.
November 22nd-24th, the 16th China National College Students Pharmaceutical Forum was officially held.Shanghai University of Medicine & Health SciencesWon the first prize in the pharmaceutical science track for innovative achievements for the first time, along with one third prize for innovative achievements and two excellent paper awards.
On November 24, the China Health Industry Innovation Summit and the 5th "Qipu Award" Ceremony were officially held.Zedman PharmaceuticalsWon the "2024 Drug Innovation Chip Nomination Award" with the innovative technology platform of AhR "Super Target".
On November 28, SRC 2024 (The 7th) Social Responsibility Conference and Ornate Awards Ceremony was officially held.LianRen HealthAwarded the "ONA Award - 2024 Responsible Technology Company of the Year."
On November 29, the 2024 Pudong Innovation and Entrepreneurship Conference officially opened.Aitia PharmaAwarded the honor of "Pudong Innovation and Entrepreneurship Star".
In November, the final of the 9th "Maker China" Intelligent Robot SME Innovation and Entrepreneurship Competition was officially held.XuanBlade TechnologyRanked among the top 50 in China with the "AI-Driven Bio-Automation Smart Manufacturing Solution" project.
November,Hansoh PharmaIn the 2024 ESG rating published by MSCI, it was rated "AA" for two consecutive years.
November,HenliusAwarded the "Best Companies to Work for in Asia" by HR Asia for three consecutive years.
November,ReCareAt the China Medical Device Innovation Products and Technology Exhibition, it was awarded "Top 100 Chinese Medical Device Brand Strength Enterprises of 2024".
Capital Dynamics
November 5,Kangqiao Traditional Chinese Medicine"Kangqiao TCM Research Think Tank Data" Successfully Listed on the Shanghai Data Exchange; Data Sources Mainly Include Classification, Characteristics, Regional Production of Herbal Medicines, and High-definition Spectra of Chinese Herbal Medicine.
November 8,Cathay BiotechReceived notice from the Shanghai Stock Exchange (SSE), stating that the private placement has passed the SSE review. CIBIO plans to conduct a private placement of no more than 6.6 billion yuan, introducing China Merchants Group as an indirect shareholder, and signing a business cooperation agreement to accelerate the positive complementarity between advanced technology and high-quality scenarios, jointly promoting the implementation and development of the synthetic biology industry.
November 11,BiocytogenAnnounced that IDEAYA has exercised its option to obtain the global exclusive license for Biocytogen's B7H3/PTK7 BsADC project IDE034 and nominated the project as a development candidate.
November 13,XtalPiSigned a strategic cooperation agreement with China Construction Bank, obtaining an intended credit line totaling 5 billion RMB (or equivalent foreign currency) to fully support XtalPi's accelerated expansion and scaled upgrading of its business operations both in China and overseas.
November 26,Photoacoustic PharmaAnnouncementCompleteCompleted tens of millions of yuan in A+ round financing, with this round led by ZHANGKE HERUN and participated by Shanghai Science and Technology Investment.
November,EnCare PharmaAnnounced the completion of a multi-million yuan A++ round of financing, led by 3SBio, with follow-up investments from Zhangke Herun, Yijin Capital, and others.
November,Shengna TechnologyAnnounced the completion of a multi-million yuan Pre-A round of financing, led by Fir Stream Capital.
November,LeadBioAnnounced the completion of an A-round financing of over 100 million yuan. This round of financing was led by Beijing Longpan Venture Capital, with participation from Tianrui Fengnian Investment, and continued additional investment from existing shareholder Zhangke Lingyi Venture Capital.
November,BRJAnnounced the completion of a multi-million yuan A+ round of financing, led by Topview Capital with participation from CAS Star and TusStar.
Pharmaceutical Transactions
November 4,Haihe PharmaceuticalsSign a distribution contract for oral paclitaxel solution with Zhiqing Company, which becomes the exclusive distributor of the product in Taiwan, China.
November 7,HenliusStrategic cooperation with SVAX to promote the global registration and commercialization of multiple products from Henlius.
On November 14, Merck &LevenMedAnnounced that Merck has reached an agreement to obtain the global exclusive license for the development, production, and commercialization of LM-299, a novel investigational PD-1/VEGF bispecific antibody from LiXin Pharmaceuticals. LiXin Pharmaceuticals will receive an upfront payment of $588 million and milestone payments of up to $2.7 billion.
November 21,MabwellAuthorization and Commercialization Agreement Signed with Strategic Partner in Peru for Two Denosumab Injection Products, 9MW0311 and 9MW0321.
(Edited by the Pharmagu Team)
