Cyagen Biosciences Secures RMB 285 Million Series B Funding; CSPC Pharmaceutical Group Receives NMPA Approval for Montelukast Sodium Tablets and Chewable Tablets

Academician Zhong Nanshan: No Controlled Trials Have Been Conducted for Chloroquine Phosphate

On February 24, at Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, the Guangdong medical team supporting Hubei conducted a remote consultation with Academician Zhong Nanshan. During a specially arranged press Q&A session, Zhong Nanshan stated that clinical treatment observations revealed that COVID-19 patients tested negative for nucleic acid after an average of 6 to 7 days of treatment with the antiviral drugs arbidol and lopinavir/ritonavir (Kaletra), whereas the average time to negative conversion was 4.2 days for those treated with the antiviral drug chloroquine phosphate. He concluded that chloroquine phosphate appears to have some efficacy, but as rigorous controlled trials have not yet been conducted, no definitive conclusions can be drawn.

Tianjin University: The Oral COVID-19 Vaccine Under Development Is Still Far from Market Launch

On February 25, Professor Huang Jinhai’s team from the School of Life Sciences at Tianjin University announced the development of an oral vaccine for the novel coronavirus. A Tianjin University spokesperson responsible for public relations confirmed the authenticity of the news, stating that while the vaccine has taken preliminary shape, it is still far from market launch. The team is currently seeking corporate partnerships to advance subsequent stages of research and development. Professor Huang emphasized that the ultimate efficacy of the vaccine must be validated through follow-up animal studies and clinical trials in humans.

《bioRxiv》: First In Vitro Synthesis of SARS-CoV-2 Achieved in Just One Week

Recently, researchers from the University of Bern and the Institute of Virology and Immunology in Switzerland, among other institutions, collaborated to present a new, non-peer-reviewed study on the preprint server bioRxiv. The study demonstrates the full functionality of a yeast-based synthetic genomics platform for the genetic reconstruction of diverse RNA viruses, including members of the Coronaviridae, Flaviviridae, and Paramyxoviridae families. Using this platform, the researchers were able to engineer and rescue chemically synthesized clones of the recently prevalent SARS-CoV-2 within one week of receiving the synthesized DNA fragments.

WuXi AppTec’s Integrated “Nucleic Acid + Antibody” Testing Supports Epidemiological Investigations and Diagnosis

Recently, Shanghai WuXi Diagnostics Medical Technology Co., Ltd. successfully developed the “2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA),” the “2019 Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (ELISA),” and the “2019 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method).” These three novel coronavirus detection kits form an “integrated testing” solution to help medical institutions rapidly and accurately diagnose patients with COVID-19, thereby supporting disease control and prevention departments at all levels in their epidemic containment efforts.

Cyagen Biosciences Completes RMB 285 Million Series B Financing to Expand Its Domestic and International Business Operations

On February 25, Cyagen Biosciences announced the completion of its RMB 285 million Series B financing round. The investing institutions included China Merchants Zhiyuan, GF Qianhe, GF Xinde, and Guanghua Venture Capital. The funds raised in this round will be used to expand Cyagen’s business scope both domestically and internationally, complete the construction of facilities totaling over 40,000 square meters across Central, North, South, and Southwest China within the year, and vigorously advance Cyagen’s strategic depth in North America, Europe, and the Asia-Pacific region. By fostering deep collaborations with industry leaders in Europe and the United States, Cyagen aims to significantly enhance its global footprint.

Huanuotai Bio Secures Angel Round Investment as Mumeng Group Continues to Expand Its Footprint in the Greater Health Industry

On February 26, Beijing Huanuotai Biopharmaceutical Technology Co., Ltd. completed its angel round of financing, with Mumeng Group as the investor. Huanuotai Biopharma is dedicated to the innovative product development in the field of vaccines, building core technology platforms, and promoting the upgrading of domestically marketed vaccine products. Wu Jiafu, Chairman of Mumeng Group, stated: "This investment will further expand Mumeng Group's layout in the biopharmaceutical sector, including sub-sectors such as vaccines, antibodies, diagnostic reagents, and rapid tests."

CSPC’s Montelukast Sodium Tablets and Chewable Tablets Receive Drug Registration Approval

On February 26, CSPC Pharmaceutical Group announced that its subsidiary, CSPC Ouyi Pharmaceutical Co., Ltd., had received drug registration approvals from the China National Medical Products Administration (NMPA) for “Montelukast Sodium Tablets (10 mg)” and “Montelukast Sodium Chewable Tablets (4 mg, 5 mg).” These products are the second in China to be deemed as having passed the Consistency Evaluation of Quality and Efficacy for Generic Drugs. Montelukast sodium is an oral formulation that significantly alleviates symptoms of asthma and allergic rhinitis.

BPI-27336 Tablets, a Novel Drug for Solid Tumor Treatment by Beta Pharma, Approved for Clinical Trials

On February 26, Beta Pharma announced that it had recently received the "Clinical Trial Notification" issued by the National Medical Products Administration (NMPA). The company’s application for clinical trials of its independently developed BPI-27336 tablets, intended for the treatment of solid tumors such as colorectal cancer, pancreatic cancer, lung cancer, liver cancer, gastric cancer, and melanoma with RAS/RAF/MEK activating mutations, has been approved by the NMPA.

FDA Accepts Filing for Roche’s Fixed-Dose Combination of Perjeta + Herceptin Subcutaneous Formulation

Recently, Roche announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) seeking approval for the subcutaneous fixed-dose combination (FDC) of Perjeta and Herceptin, administered in conjunction with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. This subcutaneous FDC formulation was developed using Halozyme’s Enhanze drug delivery technology, which is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20). This enzyme temporarily degrades hyaluronic acid in the body, facilitating faster dispersion and absorption of injected drugs, thereby enabling subcutaneous administration.

U.S. Officially Launches Clinical Trials of Gilead’s Remdesivir

On February 25, the U.S. National Institutes of Health (NIH) announced that the first clinical trial of the antiviral drug remdesivir for the treatment of COVID-19 had been launched at the University of Nebraska Medical Center in the United States, conducted using a randomized, placebo-controlled design. Remdesivir is a broad-spectrum antiviral agent under development by Gilead Sciences, Inc. Previously, the drug was primarily investigated for the treatment of diseases such as Ebola and Middle East Respiratory Syndrome (MERS), and it remains in the clinical trial phase.

Allecra Therapeutics’ Investigational Drug Exblifep Achieves Success in Phase III Clinical Trial for Complicated Urinary Tract Infections

On February 26, biopharmaceutical company Allecra Therapeutics announced that the Phase III ALLIUM clinical trial evaluating the investigational drug exblifep (AAI101) for the treatment of complicated urinary tract infections (cUTI) had met the primary endpoints pre-specified by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Furthermore, exblifep demonstrated superiority over piperacillin-tazobactam.

Gilead Has Filed Eight Patents Related to Remdesivir in China

On the morning of February 25, He Zhimin, Deputy Commissioner of the China National Intellectual Property Administration (CNIPA), stated that Gilead Sciences had filed eight patent applications in China related to the drug remdesivir. Of these, three have been granted, while five are still under examination. The scope of protection covers compounds, formulations, related manufacturing methods, and uses. Remdesivir has begun clinical trials at multiple hospitals in Wuhan, with results scheduled to be released on April 27. There is hope that a batch of drugs demonstrating positive therapeutic efficacy against novel coronavirus pneumonia will emerge as soon as possible.

Kuihua Pharmaceutical Releases 2019 Financial Results: Revenue Reaches RMB 4.366 Billion, a Year-on-Year Decrease of 2.37%

On February 25, Kuihua Pharmaceutical released its preliminary financial results for the fiscal year 2019. The total operating revenue for the previous year amounted to RMB 4.366 billion, representing a year-on-year decrease of 2.37%; the net profit attributable to shareholders of the listed company reached RMB 583 million, marking a year-on-year increase of 3.52%.

Erkang Pharmaceutical Releases 2019 Financial Results: Revenue Reaches RMB 2.75 Billion, a Year-on-Year Increase of 16.79%

On February 26, Erkang Pharmaceutical released its 2019 preliminary earnings report. During the reporting period, the company achieved operating revenue of RMB 2.75 billion, a year-on-year increase of 16.79%; net profit attributable to shareholders of the listed company amounted to RMB 163 million, representing a year-on-year decrease of 24.91%.

Dermatology Company Almirall Signs Licensing Agreement with Paratek for New Tetracycline Seysara in Greater China

On February 26, dermatology-focused company Almirall announced that it had entered into a licensing agreement with antibiotic company Paratek to secure the rights to Seysara (sarecycline tablets), a novel tetracycline, in Greater China (including mainland China, Hong Kong, and Macau). Under the terms of the agreement, Paratek will receive high single-digit royalties based on net sales of Seysara in Greater China. Seysara is an innovative therapy for patients with moderate-to-severe acne. Clinical studies have demonstrated that Seysara produces significant improvement in inflammatory skin lesions as early as three weeks after initiation of treatment, with a favorable safety and tolerability profile.

Dinghang Pharma and Moffitt Cancer Center Launch Precision Medicine Collaboration for Gastric and Gastrointestinal Cancers

On February 25, Dinghang Medicine announced a collaborative agreement with the Moffitt Cancer Center, one of the top three cancer treatment centers in the United States. The two parties will cooperate to genetically characterize and classify the tumor microenvironment of patients at Moffitt Cancer Center, aiming to better understand how various therapeutic interventions affect clinical outcomes in these patients. This collaboration will initially focus on gastric cancer and gastrointestinal cancers. Dinghang Medicine will leverage its proprietary RNA biomarker platform to characterize the patients’ tumor microenvironments.