Weekly Highlights in Life Sciences and Healthcare (No.44): Regulatory Approvals, Capital Moves, and Breakthrough Collaborations

Nov 11, 2024 17:02 CST Updated 17:02

Noya

Medical Device R&D and Manufacturer

Cathay

R&D and Manufacturing of Bio-based Materials

Weekly Dynamics of Life and Health (No.44)

2024.11.4-11.10

Innovation never stops, and progress keeps moving forward. What are the latest developments in Zhangjiang's biopharmaceutical industry over the past week? A quick overview ↓

Major Progress

November 5,PfizerAnnounced that Tazenar® (Talazoparib Tosylate Capsules) has been approved by the NMPA for marketing, 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, intended as an adjunctive treatment for adult patients with severe, active anti-neutrophil cytoplasmic antibody-associated vasculitis under standard treatment containing glucocorticoids.
November 8,Karl StorzAnnounced that the domestically produced IMAGE1 S imaging platform has been approved for marketing.
Recently,NoyaThe composite steep pulse therapeutic device HFMP-01E has received CE approval for marketing, and the portable devices Noya Elly® PCa & Noya Elly® BPH have been approved for marketing in China.
Recently,BetapharmaNew Indication for EGFR Inhibitor Rezivertinib Mesylate Capsules Approved by NMPA.
Recently,EscugenESG401 Granted Breakthrough Therapy Designation by CDE for Previously Untreated, Unresectable Locally Advanced, Recurrent, or Metastatic PD-L1-Negative Triple-Negative Breast Cancer.
Recently,Shanghai Institute of Materia MedicaIND Application for Class 1 Antibiotic New Drug SM-V-61 Approved by NMPA.
Recently,Yunsheng R&DIND Application for BCM899 Granules, a Class 2.2 New Drug, Granted Conditional Approval by CDE for Hypertension and Coronary Heart Disease.

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 Output of Herbal Materials, and High-definition Spectra of Chinese Herbal Medicine.
November 8,Cathay BiotechReceived notice from the Shanghai Stock Exchange, the private placement has passed the SSE review.。Cathay Biotech Plans to Raise No More Than 6.6 Billion Yuan through a Private Placement, Introducing China Merchants Group as an Indirect Shareholder, and Signs a Business Cooperation Agreement to Accelerate the良性 Complementarity of Advanced Technologies and High-quality Scenarios, Jointly Promoting the落地 Development of Synthetic Biology Industrialization.

CIIE Special Zone

From November 5th to 10th, the 7th China International Import Expo was successfully held in Shanghai, featuring the appearance of biopharmaceutical and medical device companies from Zhangjiang:

Boehringer IngelheimSign a clinical research strategic agreement with Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and sign a "BOAT Action" strategic cooperation memorandum with the Chinese Stroke Association.
Baxter ChinaNew Brand for Kidney Care CompaniesWanYiTeUnveiling: Wanyi Te respectively signs strategic cooperation agreements with Longyue Bio and Kerton.
Bayer Co.Lab ChinaWelcomes the first入驻企业科动生物,BayerSigned memorandums of cooperation with the China Population Welfare Foundation and the National Health Commission's Maternal and Child Health Center, respectively.Bayer HealthCare LLCSign a strategic cooperation agreement with Shanghai Pharmaceuticals Holding.
GE HealthcareRespectively withNovartis, Eisai China signs a strategic cooperation memorandum, reaching a tripartite strategic cooperation with Rich Healthcare and Yizhun Intelligence.
GSKSigned cooperation agreements with multiple partners, including Shanghai Pujie Rheumatism Care Center, China Foundation for Hepatitis Prevention and Control, and Jinan University Guangdong-Hong Kong-Macao Greater Bay Area Institute of Real-World Research on Pharmaceuticals and Medical Devices.
PfizerAztreonam Avibactam Sodium for Injection Makes Its Asian Debut, Signs Innovative Business Cooperation Agreement with Sinopharm Holding, and Deepens Pilot Cooperation with CR Guangdong Pharmaceutical.
Roche PharmaceuticalsLaunch Roche Early Lung Brand — “Together, Leading the Way to Intelligent Healing”.
MerckSigned a green electricity procurement agreement with Envision Technology Group and a non-binding cooperation agreement with the Chengdu Eastern New District Management Committee.
NovartisSigned strategic cooperation agreements with Shanghai Pharmaceuticals Holding and Chongqing Pharmaceuticals Holding, respectively signed memorandums of strategic cooperation with Philips, Beijing Anzhen Hospital, and the Beijing New Sunshine Charity Foundation, and launched the cooperation project "Aurora Plan" with the China Rare Disease Alliance.
Siemens HealthineersRelease of Co-Development Achievements with Local Innovative Enterprises – The World’s First ARTIS icono floor Integrated Multimodal Diagnosis and Treatment Platform.
AbbottFreeStyle Libre 2 Continuous Glucose Monitoring System Officially Launched, andMerckAchieve cooperation, integrate diagnosis and treatment for thyroid health management in physical examination populations, promote multidisciplinary exchange, and jointly build a thyroid health management ecosystem.
Futuo ZhidaAndSiemens HealthineersOfficially signed a cooperation agreement to comprehensively collaborate on the "one-stop lung nodule diagnosis and treatment solution."
HenliusSigned a strategic cooperation agreement with SVAX to jointly promote the global registration and commercialization of multiple products from Henlius.
Haihe PharmaceuticalSign a strategic cooperation agreement with Shanghai Pharmaceuticals Holding, focusing on the field of oncology and carrying out long-term cooperation.
I-Mab BiopharmaAndSanofiHold a product authorization cooperation signing ceremony for the innovative CD73 antibody drug Uliledlimab.
The Cord Rare Disease Center, in collaboration with numerous leading domestic and international pharmaceutical enterprises, jointly released the "Patient-Centric Pharmaceutical Enterprise Consensus Initiative." This initiative has been supported by includingAstraZeneca, Boehringer Ingelheim China, Novartis China, NineSkies BiopharmaRecognition and joint initiative from more than 20 leading domestic and international pharmaceutical enterprises, including.

Other News This Week

11On the 4th day of the month,Haihe PharmaceuticalsSign a distribution contract for oral paclitaxel solution with Intelligene, making Intelligene the exclusive distributor of the product in Taiwan, China.
November 4th-7th, the 15th World Antibody-Drug Conjugate Conference was officially held.DualityBioAwarded the "Best New Drug Developer" Champion.
November 6,Shanghai Zhangjiang Yidian Tong&China TestingThe "Undergraduate and Graduate Medical Engineering Transformation and Detection Practice Education Base" of Shanghai University of Science and Technology was officially inaugurated.
On November 6, at the EHS Management Annual Conference of the Pharmaceutical Industry,BioDuro-SundiaZhangjiang EHS Team Awarded Two EHS Management Excellence Case Awards.
November 6-10, 2024: The Annual Meeting of the Society for Immunotherapy of Cancer (SITC) was officially held.Akeso BiopharmaRelease of the Mechanism of Action Research Results for AK132, a Bispecific Antibody New Drug Targeting Claudin18.2/CD47, Independently Developed;AntengenePoster Presentation of Three Research Achievements: ATG-201, ATG-107, and ATG-106.
On November 7, hosted by the Shanghai Municipal Federation of Trade Unions and organized by the Shanghai Staff Technical Association, Pudong New Area Federation of Trade Unions, and other units,Zhangjiang GroupCo-organized by2024 Shanghai Employees Vocational Skills Series Competition——Biopharmaceutical Experimental Skills Competition and the 17th Pudong New Area Biopharmaceutical Experimental Skills Competition Award Ceremony &"Winners' Training Camp""Activity"Held at Pudong International Talent Hub.
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 CenterHold.
November 8,Dizhe PharmaceuticalsAnnounced the submission of an NDA to the FDA for Sunvozertinib, intended for adult patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy and who have been confirmed by an FDA-approved kit to have epidermal growth factor receptor exon 20 insertion mutations.
November 8,Harbour BioMedAnnounced the submission of an IND application to CDE for HBM9378/SKB378, a fully human antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of chronic obstructive pulmonary disease (COPD).
November 8,Reindeer BioAnnounced that the results of the Phase Ib/II clinical trial of its fully human BCMA-targeted CAR-T therapy, Idecabtagene Vicleucel Injection, for relapsed/refractory multiple myeloma were published inJAMA Oncology。
November 8,Huao Tai BioAnnounced the completion of patient enrollment in the pivotal Phase II clinical trial of HB0034 for the treatment of acute exacerbations of generalized pustular psoriasis.
November 8,Shanghai Zhangjiang Institute of Medical Innovation、BiotangUnitedShanghai University of Traditional Chinese MedicineThe "TCM Microecology Medical Innovation Center" jointly built has been officially established at Shanghai University of Traditional Chinese Medicine.
November 8,Shanghai PharmaceuticalsAndShenkang CenterConduct discussions and exchanges, hoping that both parties will further explore the sustainable development and open sharing mechanisms of hospital-enterprise cooperation, and seize strategic opportunities in clinical transformation, data element empowerment, and other aspects.
Recently,Gravel BiotechAndTianzeyun TaiCRISPR-AaCas12b^MAXGene editing tools and related gene editing technologies have reached a cooperation agreement for Gravel Biotech to develop, manufacture, and commercialize its specific cell therapy products.
Recently,Cathay BiotechCathay Biotech Launches Bio-based Polyamide Fiber Brand Terlon® for Textile Applications in Strategic Partnership with Hailan Home Group.
Recently,Shanghai Institute of Clinical Innovation and TranslationHeld an exchange event with the Institute of Molecular Medicine of Shanghai Jiao Tong University School of Medicine. Both parties will further deepen their cooperative relationship around aspects such as intellectual property layout, capital对接, communication with partners, and hosting thematic salons, jointly exploring a more efficient and flexible mechanism for the transfer and transformation of scientific research成果.
Recently,Shanghai University of Traditional Chinese MedicineChen Kaixian, an academician of the Institute of Chinese Materia Medica, and other teamsActa Pharmaceutica Sinica BPublished a research paper.
Recently,BGIThe prospective research results on early screening of colorectal cancer conducted in collaboration were published inAsian Pacific Journal of Cancer Prevention。
Recently,Wanhe Yuan BioThe group standards for "Human Gallbladder Cancer Organoids" and "Human Pancreatic Cancer Organoids," which were fully involved in formulating, have been officially released.

(Edited by the Yaogu Jun team)