CSBio CSBio

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[{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Announces the Results of the Phase 1\/2 Clinical Study of PCSK9 Antibody Tafolecimab at the ESC Annual Conference","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"LianBio","sponsor":"RA Capital","pharmaFlowCategory":"D","amount":"$310.0 million","upfrontCash":"Undisclosed","newsHeadline":"LianBio Announces $310 Million Crossover Financing","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Edding Pharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amarin Shares Topline Data from Partner\u2019s Pivotal Phase 3 Study of VASCEPA\u00ae (Icosapent Ethyl) in Mainland China","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Edding Pharm"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent\u2019s Phase 3 CREDIT-2 Study of IBI306 Meets Primary Endpoint","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Announces Two Registration Studies of IBI306 (anti-PCSK-9 antibody) Met Primary Endpoint","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"LianBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Announces Mavacamten Granted Breakthrough Therapy Designation in China","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Releases Results of a Phase 3 Clinical Study of IBI306 (PCSK-9 inhibitor) in Chinese Patients with Heterozygous Familial Hypercholesterolemia at the American College of Cardiology Annual Congress 2022","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"LianBio","sponsor":"MyoKardia","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Completes Phase 1 Pharmacokinetic Study of Mavacamten in Healthy Chinese Volunteers","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Announces the NMPA Acceptance of the New Drug Application for Tafolecimab Injection (anti-PCSK-9 antibody)","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"LianBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Completes Enrollment in Pivotal Phase 3 EXPLORER-CN Trial of Mavacamten in Chinese Obstructive Hypertrophic Cardiomyopathy Patients","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Releases Results of a Phase 3 Clinical Study of Tafolecimab\uff08IBI306\uff09in Chinese Patients with non- Familial Hypercholesterolemia at the American Heart Association (AHA) Scirntific Sessions 2022","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"Shanghai Junshi Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Junshi Biosciences Announces Ongericimab (anti-PCSK9 mAb) Met Primary Endpoints in Two Phase 3 Clinical Studies","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Shanghai Junshi Biosciences"},{"orgOrder":0,"company":"LianBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Announces China National Medical Products Administration (NMPA) Acceptance with Priority Review of New Drug Application for Mavacamten for the Treatment of Patients with Obstructive Hypertrophic Cardiomyopathy","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"LianBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Announces Positive Topline Results from Phase 3 EXPLORER-CN Trial Evaluating Mavacamten in Chinese Patients","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Akeso","sponsor":"AD Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NMPA Accepted Akeso's Ebronucimab (PCSK9) Marketing Application in two Cardiovascular Indications","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akeso"},{"orgOrder":0,"company":"Jixing Pharmaceuticals","sponsor":"Bayer AG","pharmaFlowCategory":"D","amount":"$162.0 million","upfrontCash":"Undisclosed","newsHeadline":"Bayer and RTW Investments Lead Series D Financing in Chinese Biotech Ji Xing Pharmaceuticals","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Jixing Pharmaceuticals"}]

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            Details:

            The financing will enable the company to support Ji Xing Pharmaceuticals in the commercialization of JIXING’s pipeline assets in the areas of cardiovascular diseases and ophthalmology.

            Lead Product(s): Aficamten

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: CK-3773274

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bayer AG

            Deal Size: $162.0 million Upfront Cash: Undisclosed

            Deal Type: Series D Financing January 06, 2024

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            NMPA has accepted its NDA for its fully human anti-PCSK9 monoclonal antibody AK102 (ebronucimab) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia.

            Lead Product(s): Ebronucimab

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AK102

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: AD Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2023

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            MYK-461 (mavacamten) is a cardiac myosin inhibitor approved by the U.S. FDA indicated for the treatment of adults with symptomatic new york heart association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.

            Lead Product(s): Mavacamten

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MYK-461

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 26, 2023

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            MYK-461 (Mavacamten) is a cardiac myosin inhibitor approved by the U.S. FDA indicated for the treatment of adults with symptomatic new york heart association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.

            Lead Product(s): Mavacamten

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MYK-461

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 21, 2023

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            JS002 (ongericimab) is a recombinant humanized anti-PCSK9 monoclonal antibody independently, being developed for the treatment of primary hypercholesterolemia and mixed hyperlipedemia.

            Lead Product(s): Ongericimab

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: JS002

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 27, 2023

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            IBI306 (tafolecimab) is an lgG2 fully human mAB that can specifically bind to PCSK-9 and reduce LDL-C level by inhibiting PCSK-9-mediated low-density lipoprotein receptor endocytosis, subsequently enhancing clearance of LDL-C, resulting in reduction in LDL-C level.

            Lead Product(s): Tafolecimab

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: IBI306

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 07, 2022

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            MYK-461 (mavacamten) is the first and only cardiac myosin inhibitor approved by the U.S. FDA indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.

            Lead Product(s): Mavacamten

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MYK-461

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2022

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            The NDA submission was based on study results of three phase 3 trial compared with placebo, IBI306 (tafolecimab) injection reduced low-density lipoprotein cholesterol (LDL-C) levels by about 57% ~ 65%, and maintained long-term therapeutic efficacy.

            Lead Product(s): Tafolecimab

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: IBI306

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 14, 2022

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            MYK-461 (mavacamten) is the first and only cardiac myosin inhibitor, that demonstrated a favorable safety, tolerability and pharmacokinetic profile in healthy Chinese volunteers.

            Lead Product(s): Mavacamten

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MYK-461

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: MyoKardia

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 09, 2022

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            Results of study showed that both IBI306 150 mg Q2W or 450 mg Q4W yielded significant reduction in LDL-C levels in Chinese patients with HeFH, and Primary endpoint: IBI306 significantly reduced LDL-C levels for 150 mg Q2W; −61.9%, for 450 mg Q4W; P<0·0001 for both comparisons.

            Lead Product(s): IBI306

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: IBI306

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 04, 2022

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