FDA Approves Audenz Vaccine for Pandemic Influenza Preparedness Amid Emergence of Novel Coronavirus with 89.1% Genetic Similarity to SARS-like Coronaviruses

《Nature》: Novel coronavirus shares 89.1% nucleotide similarity with SARS-like coronaviruses

On February 3, the prestigious international academic journal Nature published online a research paper by Professor Zhang Yongzhen’s team from the School of Public Health at Fudan University on the novel coronavirus in Wuhan. The team studied a patient who worked at the Huanan Seafood Market and was admitted to Wuhan Central Hospital on December 26, 2019, presenting with severe respiratory syndrome, including fever, dizziness, and cough. RNA sequencing of bronchoalveolar lavage fluid samples from the patient identified a novel RNA virus belonging to the family Coronaviridae. Phylogenetic analysis of its complete viral genome (29,903 nucleotides) revealed that the virus is most closely related to a group of SARS-like coronaviruses, sharing 89.1% nucleotide similarity.

NMPA: Crackdown on Illegal Manufacturing and Sale of Counterfeit and Substandard Drugs and Medical Devices During Epidemic Prevention and Control Period

On February 4, the National Medical Products Administration (NMPA) issued the “Notice on Severely Cracking Down on Illegal Activities Involving the Production and Sale of Counterfeit and Substandard Drugs and Medical Devices to Effectively Safeguard the Safety of Drugs and Medical Devices for the Prevention and Control of Novel Coronavirus Pneumonia” on its official website. The notice pointed out that in the pharmaceutical sector, priority will be given to investigating and punishing illegal activities such as the production and sale of counterfeit and substandard drugs—including those with indicated indications or therapeutic functions exceeding the approved scope, expired drugs, and drugs produced and sold without obtaining drug approval documents. In the medical device sector, priority will be given to investigating and punishing illegal activities such as passing off ordinary or industrial dust-proof masks as medical masks, and illegally producing and selling protective products like medical masks and medical protective suits by recycling expired, ineffective, or used medical masks.

Shanghai RAAS Receives “Notice of Emergency Requisition of Production Capacity”

On February 3, Shanghai RAAS received a “Notice on Emergency Requisition of Production Capacity” from the Shanghai Municipal Commission of Economy and Informatization. The Commission decided to urgently requisition Shanghai RAAS’s medical protective supplies, pharmaceuticals, medical devices, and production capacity. It is reported that the intravenous human immunoglobulin produced by Shanghai RAAS is prepared through separation and purification using human plasma as the raw material. It contains broad-spectrum antibodies and plays a role in immune enhancement and the prevention and treatment of viral infections, thus serving an important function in combating the current epidemic.

Biopharma Company BenchSci Completes $22 Million Series B Funding to Accelerate AI-Driven Drug Discovery

Recently, biopharmaceutical company BenchSci announced the completion of a $22 million Series B financing round, led by F-Prime Capital with participation from Inovia Capital and Gradient Ventures. The funds will be used to accelerate its AI-driven drug discovery efforts. While traditional antibody selection typically takes 12 weeks, BenchSci’s AI-powered antibody selection technology can complete the process in just 30 seconds. Furthermore, by reducing the use of inappropriate antibodies, the platform can save up to $3 million annually in reagent costs.

Biopharmaceutical Company Stalicla Completes $8 Million Series A Financing to Advance STP1 into Phase 1b Clinical Trials

Recently, biopharmaceutical company Stalicla announced the completion of an additional $8 million (CHF 7.7 million) in financing, bringing its total Series A funding to $18.4 million. This round was supported by a consortium of private investors from Switzerland, Europe, and the United States. The proceeds will be used to advance its candidate drug STP1 for the treatment of autism spectrum disorder (ASD) into Phase 1b clinical trials, propel its second candidate drug, STP2, into preclinical studies, and further expand its DEPIv3 development platform, which is primarily focused on neurodevelopmental disorders (NDD).

FDA Approves Seqirus’s Audenz Vaccine as a Vaccine to Combat Potential Influenza Pandemics

As the world prepares for a potential coronavirus pandemic, the U.S. government has been busy preparing for a possible influenza pandemic. On Friday, the U.S. Food and Drug Administration (FDA) approved Seqirus’s Audenz vaccine, a potential pandemic vaccine related to the H5N1 influenza virus.

Audenz is the first-ever cell-based, adjuvanted influenza vaccine designed to prevent influenza A (H5N1) during a pandemic. This novel vaccine combines Seqirus’s MF59 adjuvant with cell-based antigen manufacturing technology. In an interview with BioSpace following approval, Russel Basser, Chief Scientific Officer and Head of Research and Development at Seqirus, stated that the vaccine is intended for rapid deployment to help protect the U.S. population, with stockpiles maintained for first responders in the event of a pandemic. Speaking at the company’s manufacturing facility in North Carolina, Basser remarked that the approval of Audenz represents a critical step for both the company and the United States in preparing for an influenza pandemic.

FDA Accepts Ted Pharmaceutical’s Investigational New Drug Application for Pulmonary Fibrosis Treatment

On February 3, China Biopharm announced that its subsidiary, Beijing Tide Pharmaceutical, had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for TDI01, an innovative anti-fibrotic drug independently developed by the company, and that the application had been accepted. TDI01 is a novel-target, highly selective inhibitor of Rho-associated coiled-coil containing protein kinase 2 (ROCK2). It was designated as a key new drug under China’s 13th Five-Year Plan for Major New Drug Creation and Development. Currently, clinical trials are underway for non-alcoholic steatohepatitis (NASH) and pulmonary fibrosis.

Hongyun Huaning’s Novel Antibody Drug GMA301 for Pulmonary Arterial Hypertension Receives FDA Clinical Trial Approval

Recently, GMA301, an original monoclonal antibody new drug developed by Hongyun Huaning Biopharmaceuticals, received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). GMA301 is the world’s first novel antibody drug targeting endothelin receptor A, independently developed by Hongyun Huaning (Hangzhou) Biopharmaceutical Co., Ltd., a Chinese domestic enterprise, using its proprietary G protein-coupled receptor (GPCR) antibody technology platform. Intended for the treatment of pulmonary arterial hypertension, GMA301 breaks the current therapeutic landscape in this field, which has lacked biologic antibody therapies.

Pfizer’s Sildenafil Citrate Tablets for Pulmonary Arterial Hypertension Indication to Be Approved in China Soon

On February 3, the Center for Drug Evaluation (CDE) published a list of drugs proposed for priority review and approval, which included Pfizer’s sildenafil citrate tablets. The rationale for inclusion was its designation as a treatment for a rare disease; it had previously been included in the list of urgently needed overseas new drugs for clinical use. Sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor, was first approved in 1998 for the treatment of male erectile dysfunction (ED). In November 2009, it received FDA approval for the treatment of pulmonary arterial hypertension (PAH). The inclusion of the PAH indication in this priority review signifies that patients with pulmonary hypertension (PH) in China will soon have access to high-quality, highly effective, and affordable medication.

Pfizer’s Tafamidis Marketing Application in China Proposed for Priority Review

On February 3, the CDE website indicated that Pfizer’s marketing application for tafamidis meglumine soft capsules had been included in the proposed priority review program under Category (II) of the priority review scope, which covers four rare diseases. Tafamidis is a transthyretin (TTR) stabilizer. Currently, its approved indications include familial amyloid polyneuropathy associated with transthyretin and cardiomyopathy caused by transthyretin-mediated amyloidosis.

Roche’s New Breast Cancer Drug, Kadcyla, Approved by the National Medical Products Administration

Recently, Roche China announced that the National Medical Products Administration has officially approved Kadcyla® (trastuzumab emtansine), an innovative targeted therapy, as monotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy.

Feishuo Biological Gene Mutation Detection Kit Approved for Market Launch

Recently, the National Medical Products Administration (NMPA), following review, approved the registration of the innovative product “Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method)” manufactured by Xiamen Feishuo Biotechnology Co., Ltd. This product is intended for the qualitative detection of EGFR/KRAS/BRAF/HER2/ALK/ROS1 gene mutations in formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with non-small cell lung cancer (NSCLC).

Roche’s Venclyxto and AbbVie’s Gazyvaro Combination Recommended for EU Approval as First-Line Treatment for CLL by CHMP

Recently, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) as a first-line treatment for adult patients with chronic lymphocytic leukemia (CLL). The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is expected to make a final decision within the coming months.

Puli Pharmaceutical’s Ganciclovir Sodium for Injection Receives Marketing Authorization in Cyprus

On February 4, Poly Pharma announced that its registration application for Ganciclovir Sodium for Injection (500 mg) submitted to the Cyprus Medicines Regulatory Authority had been approved. Ganciclovir, a guanosine analogue similar to acyclovir, is the first drug effective against human cytomegalovirus. It not only inhibits all herpesviruses but also blocks pathological changes in normal lymphocytes caused by the Epstein-Barr virus.

NIH Announces Failure of HIV Vaccine Clinical Trial

On February 3, the U.S. National Institutes of Health (NIH) issued a press release stating that the HVTN 702 trial, an HIV vaccine clinical study supported by its subsidiary, the National Institute of Allergy and Infectious Diseases (NIAID), had failed and that vaccination had been halted. The NIH explained that the decision to stop vaccinations was made after an interim review by an independent data and safety monitoring board found that the vaccine regimen did not prevent human immunodeficiency virus (HIV) infection.

Akeso Biopharma Submits Filing Again; Merck Previously Acquired Rights to Its Innovative Drug for $200 Million

Recently, Akeso, Inc. has once again submitted its prospectus to the Hong Kong Stock Exchange, with Morgan Stanley and JPMorgan serving as joint sponsors. Akeso is a clinical-stage biopharmaceutical company established in 2012, dedicated to developing innovative therapeutic antibodies for applications in oncology, immunology, and other therapeutic areas. In December 2019, Akeso had previously filed its first application with the Hong Kong Stock Exchange, but it was returned two days later due to insufficient preparation of financial information.

Huahai Pharmaceutical Releases 2019 Earnings Forecast: Net Profit to Increase by Approximately 376%-465% Year-on-Year

Recently, Huahai Pharmaceutical issued its 2019 annual earnings forecast, projecting that the net profit attributable to shareholders of the listed company for 2019 would increase by RMB 405 million to RMB 500 million compared with the same period of the previous year (based on legally disclosed data), representing a year-on-year growth of approximately 376% to 465%.

Gilead Reports 2019 Financial Results: Revenue of $22.449 Billion, a 1.5% Year-Over-Year Increase

On February 4, Gilead Sciences announced its 2019 financial results, reporting total annual revenue of $22.449 billion, a 1.5% increase from 2018. Among this, sales revenue from HIV products reached $16.438 billion, representing a 12% year-over-year growth and accounting for 73.32% of the company’s total revenue, making it Gilead’s core business segment. Meanwhile, hepatitis C drugs, which once accounted for half of Gilead’s business during their peak, continued to decline, with sales revenue in 2019 falling by 20% year-over-year to $2.936 billion.

Yuheng Pharmaceutical Releases 2019 Earnings Forecast: Expected Loss of RMB 2.4–2.6 Billion

Recently, Yuheng Pharmaceutical released its earnings forecast, stating that it expects a loss of RMB 2.4 billion to RMB 2.6 billion in 2019, marking a turnaround from profit to loss compared with the previous year, when it reported a net profit of RMB 126 million in 2018. Regarding the substantial projected loss, Yuheng Pharmaceutical attributed it to the underperformance of its subsidiaries—Shanghai Huatuo Pharmaceutical Technology Development Co., Ltd., Nanjing Wanchuan Huatuo Pharmaceutical Co., Ltd., and Shanxi Pude Pharmaceutical Co., Ltd.—whose operating results fell short of expectations. Based on preliminary calculations, the company expects to recognize goodwill impairment provisions of approximately RMB 2.5 billion to RMB 2.7 billion.

Beta Pharma and EyePoint Sign Exclusive Licensing Agreement for New Ophthalmic Drug Vorolanib

On February 5, Beta Pharma announced that its controlled subsidiary, Equinox Sciences, had entered into an Exclusive License Agreement with EyePoint Pharmaceuticals, granting EyePoint the exclusive rights to develop the tyrosine kinase inhibitor Vorolanib (CM082) via local injection for the treatment of ocular diseases such as wet age-related macular degeneration (w-AMD).