BioPro Biotech Secures Tens of Millions Pre-A Financing; CSPC's Sunitinib Malate Capsule Approved as China's First Generic; Edaravone and Sodium Chloride Injection Gains Market Approval
1.Over the past 24 hours, VCBeat has monitored one financing/investment deal and one acquisition in the biopharmaceutical sector.
Baipu Biology Secures Tens of Millions in Pre-A Financing for Protein Product R&D
Recently, Baipu Biology, a provider of proteomics and metabolomics technical services, announced the completion of its tens-of-millions-level Pre-A financing round. The investment was made by the Chuangye Tianshi Relay Fund, with Qingtong Capital serving as the exclusive financial advisor. Reportedly, this marks the first financing event in the proteomics field. The funds raised will be primarily allocated to product research and development, team building, and marketing initiatives.
Boehringer Ingelheim Acquires Global Exclusive Rights to Enleofen’s Preclinical Interleukin-11 (IL-11) Platform
Recently, Boehringer Ingelheim and Enleofen Bio Pte. Ltd. (Enleofen) announced that Boehringer Ingelheim has acquired global exclusive rights to Enleofen’s preclinical interleukin-11 (IL-11) platform to develop first-in-class therapies for various fibro-inflammatory diseases. This new collaboration combines Boehringer Ingelheim’s leading expertise and comprehensive R&D pipeline in fibrotic diseases with Enleofen’s world-leading expertise in IL-11 biology and its extensive portfolio of therapeutic antibodies targeting this pathway.
2.NMPA approvals in progress: three approved, one “under review and approval,” and one accepted for review.
CSPC's Sunitinib Malate Capsules Approved as First Domestic Generic in China
Recently, CSPC Pharmaceutical Group announced that its subsidiary, CSPC Ouyi Pharmaceutical, has received drug registration approval from the National Medical Products Administration (NMPA) for Sunitinib Malate Capsules (12.5 mg). This marks the first approved generic version of this product in China and is deemed to have passed the consistency evaluation. It is reported that Sunitinib Malate Capsules (hereinafter referred to as “Sunitinib”) are a small-molecule, multi-target receptor tyrosine kinase (RTK) inhibitor with multiple mechanisms of action, including inhibition of tumor angiogenesis and suppression of tumor cell proliferation and metastasis.
Chia Tai Tianqing’s Edaravone and Sodium Chloride Injection Class 3 Generic Marketing Application Approved
On January 9, Chia Tai Tianqing announced that its marketing application for Edaravone and Sodium Chloride Injection, filed under the new Class 3 regulatory pathway, had been approved by the National Medical Products Administration (NMPA). This product is the only one to have passed the consistency evaluation for the 100 mL specification. Edaravone is a neuroprotective agent (free radical scavenger) indicated for improving neurological symptoms, activities of daily living, and functional impairment associated with acute cerebral infarction.
Walvax Biotech’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Receives Drug Registration Approval
On January 11, Walvax Biotechnology Co., Ltd. announced that it had received notification from its subsidiary, Yuxi Walvax Biotechnology Co., Ltd., confirming the formal receipt on January 10 of the Drug Registration Approval for the 13-valent pneumococcal polysaccharide conjugate vaccine, issued by the National Medical Products Administration. Independently developed by Walvax Biotechnology, PCV13 is the second 13-valent pneumococcal conjugate vaccine globally and the first such vaccine in China.
Jiayi Pharmaceutical's Marketing Application for Cinacalcet Hydrochloride Tablets (Class 4 Generic Drug) Is Under Review and Approval
Currently, the Class 4 generic drug marketing application for Cinacalcet Hydrochloride Tablets by Jiangsu Jiayi Pharmaceutical Co., Ltd. (Acceptance No. CYHS1700687) is under review and approval. As the only company in China whose marketing application for generic Cinacalcet Hydrochloride Tablets has been included in the Priority Review List, Jiayi Pharmaceutical is poised to become the first to secure approval for the first generic version of cinacalcet. Cinacalcet hydrochloride is an oral calcimimetic agent that reduces levels of parathyroid hormone, calcium, phosphorus, and the calcium-phosphorus product by enhancing the sensitivity of the calcium-sensing receptor to circulating calcium levels.
NMPA Accepts for Review Fosun Pharma’s Recombinant Fully Human Monoclonal Antibody Injection Targeting CTLA-4
On January 11, Fosun Pharma announced that its controlled subsidiaries, Henlius Biotech and Henlius Pharmaceuticals, had received clinical trial approval from the National Medical Products Administration (NMPA) for their investigational recombinant fully human monoclonal antibody injection targeting CTLA-4. The approved indications include the treatment of unresectable or metastatic melanoma, advanced renal cell carcinoma, metastatic colorectal cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), as well as adjuvant therapy for melanoma.Registration Review Subject toIt is reported that the new drug is an ipilimumab biosimilar independently developed by Fosun Pharma.。
Innovent Biologics’ Sintilimab Combined with Chemotherapy Meets Primary Endpoint in First-Line Treatment of Non-Squamous Non-Small Cell Lung Cancer
On January 13, 2020, Innovent Biologics and Eli Lilly and Company jointly announced that the interim analysis of ORIENT-11, a randomized, double-blind, Phase 3 controlled clinical study evaluating their co-developed innovative PD-1 inhibitor Tyvyt® (sintilimab injection), had met its primary endpoint. The study assessed Tyvyt® (sintilimab injection) in combination with Alimta® (pemetrexed disodium for injection) and platinum-based chemotherapy as first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (nsqNSCLC) without EGFR sensitizing mutations or ALK gene rearrangements.
Moderna Announces Positive Results from Phase 1 Clinical Study of mRNA Vaccine
Recently, Moderna, a clinical-stage company focused on mRNA therapeutics and vaccines, announced that its investigational cytomegalovirus (CMV) vaccine (mRNA-1647) achieved positive interim results for safety and immunogenicity at seven months following the third dose in a Phase 1 clinical study. Meanwhile, Moderna also announced that the first participant has been dosed in its Phase 2 dose-confirmatory study. Over the past 50 years, no vaccine for the prevention of CMV infection has been approved. mRNA-1647 is the first mRNA vaccine for an infectious disease to enter Phase 2 clinical trials.
Hengrui’s PD-1 Combination Therapy for Liver Cancer Included in Clinical Practice Guidelines
Recently, Hengrui Medicine (600276-CN) published a news release on its official website announcing that its independently developed new drug, Airuika® (camrelizumab), in combination with Aitan® (apatinib), has been included in the National Guidelines for Diagnosis and Treatment of Liver Cancer. This inclusion is based on favorable efficacy profiles, including manageable treatment-related adverse reactions and good patient tolerance, providing an superior therapeutic option for patients with advanced liver cancer.
Akari Announces Successful Phase 3 Clinical Trial of C5 Complement Inhibitor for PNH Treatment
Recently, Akari Therapeutics announced positive interim data from the Phase III CAPSTONE study evaluating nomacopan, a C5 complement inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The reported data are from the first eight patients enrolled in the study. Interim results showed that all patients treated with nomacopan achieved the primary endpoint of transfusion independence (i.e., freedom from transfusion dependence).
Eisai’s Original Drug Halaven Launched in China for the Treatment of Locally Advanced or Metastatic Breast Cancer
On January 13, 2020, Eisai Co., Ltd. announced that Halaven®, its latest-generation chemotherapy drug originally developed by Eisai, had entered the Chinese market (generic name: eribulin mesylate). Halaven® is a halichondrin-class microtubule dynamics inhibitor with unique binding properties. In addition to its mechanism of action involving the inhibition of microtubule dynamic growth, non-clinical studies have demonstrated that Halaven® exerts unique effects on the tumor microenvironment.
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BMS and Nektar Strengthen Strategic Collaboration to Advance Bempeg in Combination with Opdivo for the Treatment of Multiple Tumor Types
Recently, Nektar Therapeutics and its partner Bristol Myers Squibb (BMS) jointly announced that they have agreed on a new joint development plan to advance the immunotherapy combination of bempegaldesleukin (bempeg, NKTR-214) and Opdivo (generic name: nivolumab) into multiple new registrational trials. As part of the new strategic collaboration agreement, BMS will independently conduct and fund an Phase I/II dose optimization and expansion study evaluating first-line treatment with bempeg plus Opdivo in non-small cell lung cancer (NSCLC).
Gilead Enters Exclusive Licensing Agreement with Rockefeller University to Develop New Therapies for HIV Prevention and Treatment
Recently, Gilead Sciences announced that it has licensed from The Rockefeller University a combination of broadly neutralizing antibodies (bNAbs) against HIV, including two clinical-stage candidates, 3BNC117 and 10-1074. These investigational drugs hold potential for long-acting therapies for the treatment and prevention of HIV, as well as for cure strategies.
Jichuan Pharmaceutical’s Subsidiary Receives Drug Registration Approval for Levetiracetam Concentrated Solution for Injection
On January 13, Jichuan Pharmaceutical issued an announcement stating that its subsidiary, Jichuan Pharmaceutical Group Co., Ltd., had received the Drug Registration Approval issued by the National Medical Products Administration (NMPA) for Levetiracetam Concentrated Solution for Injection (5 mL:500 mg). This medication is indicated as adjunctive therapy for partial-onset seizures (with or without secondary generalization) in adult and pediatric epilepsy patients aged 4 years and older. It may be used as an alternative when patients are temporarily unable to take oral levetiracetam formulations.
Zelgen Biopharmaceuticals Sets Issuance Price at RMB 33.76 per Share
On January 12, Suzhou Zelgen Biopharmaceuticals Co., Ltd. released its announcement on the initial public offering (IPO) and listing on the STAR Market. The announcement stated that the issue price had been determined through consultation at RMB 33.76 per share, with subscription commencing on January 14. The total size of this issuance amounts to RMB 2.026 billion, implying a company market capitalization of RMB 8.102 billion at this price.
GE Healthcare Life Sciences FlexFactory™ Zhejiang Changxing Production Platform Officially Completed
On January 11, 2020, GE Healthcare Life Sciences announced the official completion and commencement of operations of the FlexFactory™ production platform built for Clover Biopharmaceuticals. Currently equipped with two 2,000-liter production lines, the platform will help accelerate Clover Biopharmaceuticals’ innovative development. The biosimilar “SCB-808 pre-filled small-volume injection,” indicated for the treatment of rheumatoid arthritis and ankylosing spondylitis, became the first biopharmaceutical product manufactured on this production platform.
WHO: China Has Shared Genetic Sequence Information on the Novel Coronavirus
On January 12, the World Health Organization (WHO) announced that it had received genetic sequence data of the novel coronavirus, identified in cases of viral pneumonia of unknown cause in Wuhan, China. The WHO further stated that it did not recommend imposing any travel or trade restrictions on China.
《Cell》: cPLA2-MAVS Regulates Astrocyte Pathogenicity via Metabolic Control
Recently, researchers from Harvard Medical School and other institutions published an article in Cell, revealing that the cPLA2-MAVS axis regulates the pathogenicity of astrocytes through metabolic mechanisms. The study elucidates the immunometabolic pathways activating pro-inflammatory astrocytes and analyzes the novel role of MAVS in central nervous system inflammation, providing potential targets for therapeutic intervention.
《Nature Genetics》: Study Identifies 191 Breast Cancer-Associated Genes
Recently, *Nature Genetics* published a research paper on the precise localization of target genes for breast cancer. This unprecedentedly large-scale study was led by the University of Cambridge and Harvard University, involving nearly 500 researchers from 458 scientific institutions. The researchers performed fine-mapping of all known breast cancer risk regions using dense genotype data from over 217,000 participants, sourced from the Breast Cancer Association Consortium (BCAC) and the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). Through large-scale population data analysis and genotyping array analysis, 191 potential target genes were precisely identified within 150 high-risk regions for breast cancer.