Opmbio Secures RMB 1 Billion in New Financing; SARS Drug Shows Potential Against COVID-19

Google AI Predicts Protein Structure of Novel Coronavirus

Recently, according to foreign media reports, Google’s artificial intelligence division is joining global efforts to gain a deeper understanding of the novel coronavirus. Google’s UK research team is using DeepMind’s new deep learning system, AlphaFold, to predict the protein structures of the novel coronavirus. According to the latest statistics, scientists around the world are sparing no effort to understand this new virus, and DeepMind’s findings are expected to reduce the time required to determine viral protein structures.

Italian Researchers Find Evidence of RNA Editing of SARS-CoV-2 in the Human Body

Recently, researchers from the University of Siena in Italy published a research paper on the preprint platform bioRxiv. By analyzing the RNA sequences of the novel coronavirus (SARS-CoV-2) in the bronchoalveolar lavage fluid of two patients from Wuhan, they found that human host deaminases (APOBECs/ADARs) are involved in the RNA editing of the SARS-CoV-2 transcriptome, a process that may have profound implications for the interaction between SARS-CoV-2 and patients.

University of Chicago: Drugs Used to Treat SARS May Be Effective Against COVID-19

Recently, researchers identified a potential drug target from a new protein map of SARS-CoV-2, the virus responsible for coronavirus disease 2019 (COVID-19), which was first detected in 2019. A team comprising the University of Chicago, Argonne National Laboratory, Northwestern University’s Feinberg School of Medicine, and the University of California, Riverside School of Medicine, elucidated this structure. The scientists stated that their findings suggest drugs previously used to treat early SARS outbreaks could now be developed into effective therapies against COVID-19.

Aupubio Completes RMB 100 Million New Round of Financing to Expand Media Production Lines and CDMO Service Platform

On March 9, OPM Biologics announced the completion of a new round of financing amounting to RMB 100 million, with China Life Health Care Fund as the new investor. Haoyue Capital served as the exclusive financial advisor for this transaction. The funds raised in this round will be used to expand the culture media production line and the CDMO service platform, as well as to attract talent and expand overseas business.

FDA Grants Orphan Drug Designation to TG Therapeutics’ Novel Follicular Lymphoma Drug Umbralisib

Recently, biopharmaceutical company TG Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to umbralisib (TGR-1202) for the treatment of follicular lymphoma (FL). FL is a typical slow-growing or indolent subtype of non-Hodgkin lymphoma (NHL) and represents the most common form of indolent lymphoma, accounting for approximately 20% of all NHL cases. Previously, the FDA had granted orphan drug designation (ODD) to umbralisib for the treatment of patients with all three subtypes of marginal zone lymphoma (MZL).

ZSP0678 Tablets, a Class I Innovative Drug from Zhongsheng Pharma, Receives Clinical Trial Approval for New Indication

On March 8, Zhongsheng Pharmaceutical announced that its controlled subsidiary, Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd., had received a "Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA) for the new indication of its Class 1 innovative drug ZSP0678, which is proposed for the treatment of primary biliary cholangitis (PBC). The approval permits clinical trials of ZSP0678 for this new indication.

FDA Approves Recordati’s Isturisa Oral Tablets for the Treatment of Adult Patients with Cushing’s Disease

Recently, the FDA announced the approval of Isturisa (osilodrostat) oral tablets for the treatment of adult patients with Cushing’s disease who are unable to undergo pituitary surgery or who continue to suffer from the disease after pituitary surgery. Isturisa is an 11β-hydroxylase inhibitor developed by Novartis. Last July, Italy’s Recordati acquired the global development and commercialization rights for Isturisa from Novartis.

Chia Tai Tianqing Pharmaceutical's Tirofiban Hydrochloride and Sodium Chloride Injection Officially Approved

Recently, Chiatai Qingchunbao Pharmaceutical’s Tirofiban Hydrochloride and Sodium Chloride Injection has officially received approval. Data indicate that tirofiban is a non-peptide platelet glycoprotein (GP) IIb/IIIa receptor antagonist with high selectivity and specificity for the platelet IIb/IIIa receptor. In combination with heparin, tirofiban is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischemic events. It is also indicated for patients with acute coronary syndrome undergoing percutaneous coronary intervention or intracoronary plaque excision to prevent cardiac ischemic complications associated with sudden occlusion of the treated coronary artery.

Jingxin Pharmaceutical's Azithromycin Tablets Pass Consistency Evaluation

On March 6, Jingxin Pharmaceutical announced that the company had recently received the "Drug Supplemental Application Approval" issued by the National Medical Products Administration (NMPA) for the chemical drug "Azithromycin Tablets," indicating that the drug has passed the generic drug consistency evaluation. Azithromycin Tablets are macrolide antibiotics suitable for various infections caused by susceptible bacteria and were developed by Pfizer Inc.

AbbVie’s Maviret Approved in EU, Simplifying Hepatitis C Treatment

Recently, AbbVie announced that the European Commission (EC) has approved a variation to the marketing authorization for Maviret (glecaprevir/pibrentasvir), a pangenotypic hepatitis C therapy. The approval shortens the treatment duration from 12 weeks to 8 weeks for treatment-naive patients with genotype 3 (GT 3) chronic hepatitis C (HCV) infection and compensated cirrhosis.

UpperHaiyao Pharmaceutical’s Eszopiclone Tablets Pass Generic Drug Consistency Evaluation

On March 9, Shanghai Pharmaceuticals announced in an evening filing that its controlled subsidiary, SPH Zhongxi, had received the “Approval for Supplementary Drug Application” from the National Medical Products Administration (NMPA) for eszopiclone tablets, indicating that the drug has passed the consistency evaluation for generic drugs. Eszopiclone tablets are primarily used for the treatment of insomnia.

Luye Pharma’s Class 1 Novel Analgesic Drug LY03014 Is Set to Enter Clinical Trials

On March 9, Luye Pharma Group announced that the clinical trial application for its Class 1 chemical new drug, LPM3480392 injection (LY03014), has been accepted by the Center for Drug Evaluation of China’s National Medical Products Administration, paving the way for imminent clinical trials. LY03014 is an innovative analgesic independently developed by Luye Pharma based on its New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, and is intended for the treatment of moderate to severe postoperative pain and cancer breakthrough pain.

ZM-Alliance Medicine’s Investigational HBV Capsid Assembly Inhibitor ZM-H1505R Completes First-in-Human Dosing in U.S. Phase I Clinical Trial

Recently, Shanghai Zhimeng Pharmaceutical Technology Co., Ltd. announced that the first-in-human clinical trial of ZM-H1505R in the United States has completed dosing for the first cohort. Following evaluation by the Safety Review Committee, the drug demonstrated a favorable safety profile and has successfully advanced to the second dose cohort. ZM-H1505R is a novel investigational hepatitis B virus (HBV) capsid assembly inhibitor developed by Zhimeng Pharma for the treatment of chronic HBV infection.

Fosun Pharma Subsidiary’s FCN-207 Tablets Clinical Trial Application Accepted for Review

On March 6, Fosun Pharma announced in an evening statement that its controlled subsidiary, Chongqing Fuchuang Pharmaceutical Research Co., Ltd., had received a “Notice of Acceptance.” The company’s independently developed innovative small-molecule chemical drug, FCN-207 tablets, indicated for the treatment of hyperuricemia or gout, has been accepted by the National Medical Products Administration for clinical trial registration review.

Lilly’s CGRP Antibody Drug Emgality Faces Setback in EU for New Indication Application

Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a review opinion recommending the refusal of approval for Eli Lilly’s new indication application for Emgality (galcanezumab) in the treatment of episodic cluster headache (ECH) in adults. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final decision expected within the next two to three months. As the EC typically adopts the CHMP’s recommendations, this means that the new indication for Emgality in treating ECH is highly likely to be denied approval.