Chinese Research Team Identifies Two SARS-CoV-2 Subtypes; Beta Pharma Announces Non-Public Offering to Raise Up to RMB 1.002 Billion for New Drug Development

National Science Review: Chinese Research Team Discovers That the Novel Coronavirus Has Mutated, Evolving Into Two Subtypes

On March 3, the latest findings from a Chinese research team revealed that the novel coronavirus has recently accumulated 149 mutation sites and evolved into two subtypes: the L subtype and the S subtype. The study found significant differences between these two subtypes in terms of geographic distribution and prevalence among populations. The S subtype is the relatively older version, while the L subtype is more aggressive and highly contagious. This study was published in National Science Review, sponsored by the Chinese Academy of Sciences.

National Health Commission Issues Clinical Treatment Protocol for Convalescent Plasma from Recovered COVID-19 Patients (Trial Version 2)

On March 4, the official website of the National Health Commission released the “Notice on Issuing the Clinical Treatment Protocol for Convalescent Plasma from Recovered COVID-19 Patients (Trial Version 2).” This version primarily revised the sections on donor recruitment, laboratory testing, and clinical application guidelines.

Biopharmaceutical Company Inovio Accelerates Development of COVID-19 DNA Vaccine INO-4800

On March 4, 2020, biopharmaceutical company Inovio Pharmaceuticals announced that it was accelerating the development of INO-4800, a DNA vaccine against coronavirus disease 2019 (COVID-19). Reportedly, Inovio planned to initiate human clinical trials in the United States in April, followed shortly thereafter by trials in China and South Korea, the countries most severely affected by the epidemic at the time.

Beta Pharma Plans to Raise No More Than RMB 1.002 Billion for New Drug Development

On March 3, Beta Pharma released its plan for the 2020 non-public offering of A-shares. The company intends to raise no more than RMB 1.002 billion through the non-public offering, with the number of shares issued not exceeding 30% of the total share capital prior to the issuance, i.e., no more than 120.3 million shares (inclusive). According to the announcement, the net proceeds from this non-public offering, after deducting issuance expenses, will be used for new drug research and development (R&D) and R&D equipment upgrades, as well as to supplement working capital. Among these, approximately RMB 742 million will be allocated to the new drug R&D and R&D equipment upgrade project. This project was launched in 2020, with an expected total construction period of 48 months. The company stated that the funds raised will help advance its new drug R&D projects, achieve high-quality and efficient development, and further enhance its profitability.

Luye Pharma’s New Antidepressant LY03005 NDA Accepted by the FDA

On March 4, 2020, Luye Pharma Group announced that the U.S. Food and Drug Administration (FDA) had completed its filing review of LY03005, a novel compound independently developed by the company, and had formally accepted its New Drug Application (NDA) for marketing approval. Indicated for the treatment of depression, LY03005 is the second central nervous system (CNS) new drug from Luye Pharma to reach the NDA stage in the United States. LY03005 is an exclusive CNS product developed based on Luye Pharma’s novel chemical entity/new therapeutic entity (NCE/NTE) platform.

Roche’s Oral Anti-Fibrotic Therapy Esbriet Receives FDA Breakthrough Therapy Designation

Recently, Genentech, a member of the Roche Group, announced that the U.S. FDA has granted Breakthrough Therapy Designation to Esbriet (pirfenidone) for the treatment of adult patients with unclassifiable interstitial lung disease (uILD). Esbriet (pirfenidone) is an oral medication approved for the treatment of idiopathic pulmonary fibrosis (IPF), exhibiting both antifibrotic and anti-inflammatory effects. It is currently marketed in more than 60 countries worldwide. Esbriet was approved in Europe in 2011 for the treatment of adults with mild-to-moderate IPF, and received U.S. approval for the treatment of IPF patients in October 2014.

Innovent Biologics’ Pemigatinib Completes First-Ever Dosing in China for Patients with Advanced Cholangiocarcinoma

On March 4, 2020, Innovent Biologics announced that the first patient in China had been dosed in its pivotal Phase 2 registrational clinical study of pemigatinib, an FGFR1/2/3 inhibitor. The study aims to evaluate the efficacy and safety of pemigatinib in Chinese patients with advanced cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements, who have previously received at least one line of systemic therapy. The results of this study will support the New Drug Application (NDA) for pemigatinib in China.

HUTCHMED Releases 2019 Financial Results: Revenue of $204.9 Million, a 4.3% Year-on-Year Decrease

On March 3, Hutchison China MediTech Limited announced its 2019 financial results, reporting full-year revenue of $204.9 million, a 4.3% year-on-year decrease; a net loss of $106 million; and R&D expenses of $138 million, a 3% year-on-year decrease. It is reported that in 2020, Hutchison Medicine will initiate Phase II studies in China on sintilimab/toripalimab in combination with fruquintinib/surufatinib; release Phase III clinical data for savolitinib in the treatment of renal cell carcinoma, following the previously announced termination of the trial last year; and establish a commercialization team to market surufatinib after its launch.

Gene Sequencing Company Illumina Launches TSO500 ctDNA, a Liquid Biopsy Product for Comprehensive Variant Analysis

Recently, Illumina launched TruSight™ Oncology 500 ctDNA (TSO500 ctDNA), a liquid biopsy product for comprehensive genomic profiling (CGP). It can serve as a complement to tissue-based testing and as an alternative when tissue samples are unavailable. Leveraging Illumina’s mature hybrid capture technology, TSO500 ctDNA enables customers to detect variants in 523 genes from circulating tumor DNA (ctDNA) within cell-free DNA (cfDNA) samples.

China’s National Healthcare Security Information “One-Code Pass” Continues to Be Implemented; Second Batch of 6,000 Drug Records Released

On March 2, the National Healthcare Security Administration (NHSA) publicly displayed the second batch of drug information from the Medical Insurance Drug Classification and Code Database through the dynamic maintenance window for medical insurance information business coding standards. This update involved a total of 5,899 data entries. Consistent with the first batch, the display is organized into three search fields: pharmaceutical enterprises, registered names, and approval numbers, with a dedicated section for medical insurance drug catalog information. This initiative achieves standardization of medical insurance information services, ensuring “vertical integration across all levels and horizontal coverage across all areas.”