Clinical Data on Convalescent Plasma Therapy Disclosed by National Health Commission and Zhejiang University Team's Discovery of SARS-CoV-2 in Tears and Conjunctival Secretions

National Health Commission: Plasma from 544 donors has been collected nationwide for clinical treatment

On February 28, Guo Yanhong, Inspector General of the Bureau of Medical Administration and Hospital Management under the National Health Commission, stated that as of that date, plasma had been collected from 544 donors across China for the clinical treatment of 245 patients with COVID-19. Monitoring of 157 of these patients for more than 48 hours showed clinical improvement in 91 cases. She expressed hope that more recovered and discharged patients would actively donate plasma.

Journal of Medical Virology: Zhejiang University Team First Detects Novel Coronavirus in Tears and Conjunctival Secretions

On February 26, a research team led by Professor Shen Ye, Deputy Director of the First Affiliated Hospital, Zhejiang University School of Medicine and academic leader in ophthalmology, published an online study in the Journal of Medical Virology. The study revealed that among the COVID-19 patient samples analyzed, tear and conjunctival secretion samples from one patient with conjunctivitis tested positive for the virus via nucleic acid testing.

Zhong Nanshan's Team and Tencent Establish Joint Laboratory to Leverage AI for Epidemic Prevention and Control

On February 27, Academician Zhong Nanshan’s team and Tencent announced a strategic partnership to jointly establish the Joint Laboratory for Big Data and Artificial Intelligence. The laboratory will focus on advancing big data and artificial intelligence (AI) technologies to assist in screening, prevention, control, and early warning for epidemics, respiratory diseases, and thoracic conditions. Reportedly, the laboratory leverages the resources of the National Clinical Research Center for Respiratory Diseases, the State Key Laboratory of Respiratory Disease, and the Guangzhou Institute of Respiratory Health, all led by Academician Zhong Nanshan’s team. It also integrates Tencent’s internet healthcare service capabilities and its expertise in big data and AI from internal units such as the Healthcare Division and the Tianyan Laboratory. Academician Zhong Nanshan himself serves as the Director of the laboratory.

State Council Joint Prevention and Control Mechanism: Launch Online Services to Further Strengthen Epidemic Prevention and Control in Hubei

On February 26, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council for COVID-19 issued the "Notice on Launching Online Services to Further Strengthen Epidemic Prevention and Control in Hubei Province." The Notice pointed out that a national-level remote consultation platform, primarily targeting severe and critically ill COVID-19 patients in Hubei, should be established and integrated with the unified provincial platform of Hubei. This platform would provide free services such as remote video consultations, remote imaging diagnosis, and remote ward rounds to designated medical institutions for COVID-19 treatment in Hubei Province, as well as remote medical services for other difficult and complicated cases.

Israel Says a Coronavirus Vaccine Is Expected to Begin Clinical Trials Within Three Months

On February 27, the Israeli Ministry of Science and Technology announced that researchers in the country are accelerating the development of an oral vaccine for the novel coronavirus, with clinical trials expected to begin within 90 days. Israeli Minister of Science and Technology Ofir Akunis stated that the institution developing the vaccine is the Migal-Galilee Research Institute, and the ministry will expedite all approval processes related to this vaccine to facilitate its early market entry. In a statement released on the same day, the Migal-Galilee Research Institute said that the new vaccine is based on a vaccine against avian coronaviruses developed over the past four years, which has proven effective in animal experiments.

Aixin Dawei Completes Hundred-Million-Yuan A+ Round Financing to Advance Clinical Development of AST-3424

On February 28, Shenzhen Aixin Dawei Pharmaceutical Technology Co., Ltd. announced that it had completed its RMB 100 million Series A+ financing round at the end of 2019. The round was led by Guozhong Venture Capital, with participation from BGI Win-Win, Cowin Capital, Kangchengheng, and existing shareholder Sulan Investment. The proceeds will be primarily used to advance the Phase I/II clinical trials of the company’s AST-3424 project in China, accelerate preclinical registration studies for multiple innovative candidates in its product pipeline, and further expand the company’s team.

Gilead to Acquire Oncology Immunotherapy Company Forty Seven

On February 28, Gilead Sciences announced that it had submitted an acquisition offer to Forty Seven, a company specializing in cancer therapies that leverage the immune system to combat tumors. Forty Seven’s core pipeline asset is an investigational CD47-targeting antibody drug.

Huahai Pharmaceutical's Levetiracetam Tablets Approved for Marketing by the National Medical Products Administration

On February 27, Huahai Pharmaceutical issued an announcement stating that its Levetiracetam Tablets have recently been approved for marketing by the National Medical Products Administration (NMPA). The approval was granted under Category 4 of the new registration classification, which is deemed equivalent to passing the consistency evaluation. Levetiracetam Tablets are primarily indicated for the treatment of partial-onset seizures (with or without secondary generalization) in adults and children aged 4 years and older with epilepsy, as well as for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and adolescents aged 16 years and older with epilepsy.

FDA Approves Biohaven’s New Migraine Drug Nurtec ODT for Market Launch

On February 28, pharmaceutical company Biohaven announced that the FDA had approved its CGRP receptor inhibitor Nurtec (rimegepant) orally disintegrating tablets (ODT) for the acute treatment of migraine attacks in adults. The press release noted that this is the first small-molecule CGRP receptor antagonist available in a rapidly dissolving oral tablet formulation. A single dose of Nurtec ODT enables patients to return to normal function within one hour, with efficacy lasting up to 48 hours in many patients.

GlaxoSmithKline’s Cancer Drug Zejula Enters EU Review, Reducing Risk of Disease Progression or Death by 38%

Recently, GlaxoSmithKline (GSK) announced that the European Medicines Agency (EMA) has accepted a Type II variation application for Zejula (niraparib), a targeted anticancer drug. The application seeks approval for Zejula as a maintenance therapy for patients with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy, regardless of their biomarker status. This application is based on the results of the Phase III PRIMA study, which met its primary endpoint: in the overall study population (regardless of biomarker status), Zejula reduced the risk of disease progression or death by 38% compared with placebo when used as first-line maintenance therapy.

FDA Grants Priority Review to New Indication for Crysvita, the World’s First FGF-23-Targeting Monoclonal Antibody

Recently, pharmaceutical company Ultragenyx and its partner Kyowa Kirin jointly announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Crysvita (burosumab) and granted it Priority Review. The sBLA seeks approval for a new indication of Crysvita for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized (tumor-induced osteomalacia, TIO).

GSK’s Trelegy Ellipta Single-Inhaler Triple Therapy Enters Review in the EU for New Indication

Recently, GlaxoSmithKline (GSK) and its partner Innoviva jointly announced that the European Medicines Agency (EMA) has accepted a regulatory submission seeking approval for a new indication of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a once-daily single-inhaler triple therapy, for the treatment of asthma in adults. In the United States, the application for this new indication of Trelegy Ellipta for adult asthma is currently under review by the FDA.

Amgen Completes Final Interim Analysis of Phase III Trial for Novel Chronic Heart Failure Drug Omecamtiv Mecarbil

Recently, Amgen, in collaboration with its partners Cytokinetics and Servier, jointly announced that the Data Monitoring Committee (DMC) had recently completed the second and final planned interim analysis of the Phase III GALACTIC-HF trial evaluating the novel cardiac myosin activator omecamtiv mecarbil for the treatment of heart failure. This analysis included an assessment of pre-specified criteria for futility and superiority. The DMC reviewed data from the GALACTIC-HF trial and recommended continuing the study without modifications. Top-line results are expected in the fourth quarter of 2020.

Beigene and Two Other Companies Jointly Announce Launch of Phase I Clinical Trial for B-RAF Inhibitor

On February 28, MapKure, BeiGene, and SpringWorks Therapeutics jointly announced that the first patient had been dosed in Australia in a Phase 1 clinical trial evaluating BGB-3245, an investigational next-generation B-RAF inhibitor, for the treatment of patients with advanced or recurrent solid tumors. The companies also announced that the Investigational New Drug (IND) application for BGB-3245 had been cleared by the U.S. Food and Drug Administration (FDA), allowing the trial to be expanded to clinical research institutions in the United States.

Shuanglu Pharmaceutical Announces 2019 Financial Results: Revenue of RMB 2.018 Billion, a Year-on-Year Decrease of 6.88%

On February 28, Shuanglu Pharmaceutical released its 2019 annual performance flash report. During the reporting period, the company achieved operating revenue of RMB 2.018 billion, a year-on-year decrease of 6.88%; operating profit of RMB 586 million, a year-on-year decline of 14.03%; total profit of RMB 586 million, a year-on-year decline of 12.74%; and net profit attributable to shareholders of the listed company of RMB 509 million, a year-on-year drop of 10.91%.

Beida Pharmaceutical Announces 2019 Financial Results: Revenue Reaches RMB 1.547 Billion, a Year-on-Year Increase of 26.38%

On February 27, Beta Pharma released its 2019 annual performance flash report, stating that during the reporting period, sales of its product icotinib continued to ramp up. The company achieved a total operating revenue of RMB 1,547.1079 million for the full year, representing a year-on-year increase of 26.38%. The net profit attributable to shareholders of the listed company amounted to RMB 223.3756 million, a year-on-year increase of 33.90%.

Auskang Bio and Biocytogen Reach Strategic Cooperation

On February 25, Auscon Biologics reached a strategic cooperation intention with Beijing Biocytogen Genetech Co., Ltd. This marks a strong alliance between a contract development and manufacturing organization (CDMO) for biologics and a highly distinctive domestic enterprise specializing in antibody drug R&D collaboration and services. Biocytogen provides global biopharmaceutical clients with one-stop new drug R&D collaboration and services, ranging from target identification to Investigational New Drug (IND) application. By leveraging RenMab mice for high-throughput generation of fully human antibodies and employing target-humanized mice for in vivo efficacy evaluation, Biocytogen has established a unique, highly efficient, and scalable platform for antibody drug development within the industry.