Ayu Pharma Completes C-round Financing of Several Hundred Million RMB; Zhuocheng Huisheng, an IVD Reagent Developer, Secures 50 Million RMB in Series B Funding

Gilead’s Remdesivir Granted FDA Orphan Drug Designation for the Treatment of Novel Coronavirus

On March 23, the FDA’s official database showed that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation to remdesivir, an investigational antiviral therapy developed by Gilead Sciences, for the treatment of coronavirus disease 2019 (COVID-19). Currently, Gilead is conducting six clinical trials to evaluate the efficacy of remdesivir in treating patients with different types of COVID-19. Among these, two clinical trials being conducted in China are expected to yield results in April.

WHO Warning: Ibuprofen May Worsen COVID-19

Recently, the World Health Organization (WHO) issued a recommendation stating that the use of the anti-inflammatory drug ibuprofen may exacerbate COVID-19 symptoms, urging caution in its use. The public is advised to seek medical consultation from a physician for fever or discomfort rather than purchasing medication directly from pharmacies.

Scientists Discover a Fourth Potential Drug Target for COVID-19

Recently, the U.S. Center for Structural Genomics of Infectious Diseases (CSGID) identified and analyzed two key SARS-CoV-2 proteins—NSP16 and NSP10. This marks the fourth SARS-CoV-2 protein structure determined by CSGID scientists as a potential drug target. The other three important viral replication protein structures previously identified are the nsp15 endonuclease, the nsp3 ADP-ribose phosphatase, and the nsp9 replicase.

Biotech Company AusDiagnostics’ SARS-CoV-2 Test Kit Receives EU CE Certification

On March 23, biotechnology company AusDiagnostics announced that its multiplex PCR test kit for SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) has received CE marking. The assay is based on AusDiagnostics’ Multiplex Tandem PCR technology, which enables the detection of multiple pathogens at low concentrations in a sample, as well as other pathogens present at high concentrations.

Yahong Medicine Completes C-Round Financing of Hundreds of Millions of RMB to Accelerate the Development of First-in-Class Global Innovative Drugs

On March 24, 2020, Yihua Pharmaceutical Technology Co., Ltd. announced the completion of its Series C financing, raising hundreds of millions of RMB. The Series C+ round is also expected to be completed in the near future. This round was led by Yanyuan Innovation Capital, with participation from investment firms such as Guozhong Venture Capital and Yifeng Capital. Existing investors from the Series B round, Beijing Longpan and Kaitai Capital, continued to increase their investments through cooperative funds. The funds raised will be used to support the advancement of multiple independently developed projects within the company.

Zhuocheng Huisheng, an IVD Reagent Developer, Completes RMB 50 Million Series B Financing

Recently, Zhuocheng Huisheng, an in vitro diagnostic (IVD) reagent developer, announced the completion of its RMB 50 million Series B financing round. The round was led by Yuansheng Venture Capital, with participation from Qingke Venture Capital and existing shareholder Wancheng Capital. Leveraging multiplex PCR technology as its core R&D platform, Zhuocheng Huisheng has developed and manufactured over 300 PCR testing reagents. Its product portfolio spans multiple series, including tests for foodborne and gastrointestinal infections, febrile respiratory illnesses, fever with rash, emerging and re-emerging infectious diseases, antimicrobial resistance gene detection, and zoonotic pathogen detection. Several of its products have obtained EU CE certification.

Novartis’ Next-Generation Ophthalmic Drug Beovu Approved by the EU for the Treatment of Wet Age-Related Macular Degeneration

Recently, Novartis announced that the European Commission (EC) has approved Beovu (brolucizumab, also known as RTH258), a next-generation ophthalmic drug, for the treatment of wet age-related macular degeneration (wet AMD, also known as neovascular AMD or nAMD). This approval applies to all 27 EU member states, as well as the United Kingdom, Iceland, Norway, and Liechtenstein. Beovu is a next-generation anti-vascular endothelial growth factor (VEGF) agent that was approved in the United States in October 2019 for the treatment of wet AMD.

Zelgen Pharmaceuticals Submits New Drug Application for Donafenib Tosylate Tablets

On March 23, Zelixir Pharmaceuticals announced that it had submitted a New Drug Application (NDA) for donafenib tosylate tablets, an independently developed drug, to the National Medical Products Administration (NMPA), and is currently awaiting formal acceptance. Previously, in the Prospectus for the Initial Public Offering and Listing on the STAR Market of Suzhou Zelixir Biopharmaceutical Co., Ltd., the company disclosed that it expected to complete the Phase III clinical trial of donafenib as first-line treatment for advanced hepatocellular carcinoma by the end of 2019 or early 2020, and to submit the NDA in the first quarter of 2020. Donafenib tosylate tablets are an oral multi-target, multi-kinase inhibitor small-molecule anti-tumor drug developed by Zelixir Pharmaceuticals. Classified as a Class 1 new drug, the product is protected by independent intellectual property rights owned by the company.

AbbVie’s Venclexta Combined with Azacitidine Meets Primary Endpoint in Phase III Trial as First-Line Treatment for Acute Myeloid Leukemia

AbbVie Announces Positive Topline Results from Phase III VIALE-A (M15-656) Study of Venclexta (venetoclax) as First-Line Treatment for Acute Myeloid Leukemia (AML)The results demonstrated that the study met its co-primary endpoints: venetoclax plus azacitidine showed statistically significant improvements in overall survival (OS) and composite complete response rate (CR+CRi) compared with placebo plus azacitidine. The safety profile observed in this study was generally consistent with that seen in prior Phase I/II studies and with the known safety profiles of each drug individually.

Pharmaceutical Company Biohaven Announces Intranasal CGRP Receptor Antagonist Vazegepant Enters Phase III Clinical Trials

Recently, Biohaven announced the successful completion of its interactions with the U.S. Food and Drug Administration (FDA) regarding the Phase II clinical and nonclinical development of intranasal vazegepant for the acute treatment of migraine. The company has addressed all questions raised by the FDA and will advance the 10 mg intranasal vazegepant regimen into a double-blind, placebo-controlled Phase III clinical trial. Vazegepant is a third-generation, high-affinity, selective, structurally unique small-molecule CGRP receptor antagonist, and it is the only intranasal CGRP receptor antagonist currently in late-stage clinical development.

Ascentage Pharma’s Bcl-2 Inhibitor APG-2575 Completes First Patient Dosing in the U.S. in Global Phase Ib/II Clinical Study

On March 23, 2020, Ascentage Pharma announced that the first patient had been dosed in the United States in its global Phase Ib/II study evaluating APG-2575, a novel, first-in-class selective Bcl-2 inhibitor, as monotherapy or in combination therapy for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This global, multicenter, open-label Phase Ib/II dose-finding and efficacy-exploration study aims to assess the safety and tolerability of APG-2575, either as monotherapy or in combination with rituximab or acalabrutinib, in patients with relapsed/refractory CLL/SLL, and to preliminarily evaluate its efficacy.

Boehringer Ingelheim and Zealand Terminate Research on Islet Amyloid Polypeptide Analog

Recently, German pharmaceutical company Boehringer Ingelheim decided to terminate its research on amylin analogs in collaboration with Zealand Pharma and has returned the global rights to these amylin analogs, including the once-weekly lead molecule, to Zealand. Neither party disclosed specific details regarding why Boehringer Ingelheim abandoned the development of the amylin analog program. Zealand stated that it is evaluating the development pathway for the amylin analog program within its portfolio and will determine the next steps for the project after a thorough assessment.

AstraZeneca and Schrödinger Expand Partnership to Accelerate Drug Development

On March 24, 2020, Schrödinger, a company focused on leveraging computational platforms to accelerate drug development, and AstraZeneca decided to expand the scope of their existing collaboration. The aim is to optimize key properties of biologics, such as affinity and selectivity, through Schrödinger’s Free Energy Perturbation (FEP) technology, thereby accelerating the development of antibody and protein therapy candidates.