Experts Clarify Misstatement: SARS-CoV-2 Is Not SARS; Nucleic Acid Testing No Longer Sole Diagnostic Criterion

Academician of the Chinese Academy of Engineering: The Novel Coronavirus Is Not the SARS Coronavirus, and Five Additional Drugs Found to Inhibit the Virus

On February 9, the Hubei Provincial Command Center for COVID-19 Prevention and Control held a press conference. Addressing the progress in scientific research and technological breakthroughs for COVID-19 prevention and control, Chen Huanchun, an academician of the Chinese Academy of Engineering, stated that three potential drugs capable of inhibiting viral replication had been initially identified for the treatment of COVID-19, and five additional drugs with antiviral effects had recently been discovered. Meanwhile, Academician Chen clarified at the press conference:The novel coronavirus is not the SARS coronavirus; the previous statement made at the regular press conference on COVID-19 prevention and control in Hubei Province was a slip of the tongue.

Experts Respond to "False Negatives" in Nucleic Acid Testing: Nucleic Acid Is No Longer the Sole Diagnostic Criterion

On February 9, the Hubei Provincial Command Center for COVID-19 Prevention and Control held a press conference. Xu Shunqing, Deputy Dean of the School of Public Health at Huazhong University of Science and Technology, stated that nucleic acid testing has a certain rate of false negatives, meaning some infected patients are not detected. This may result in some sources of infection not being properly identified, posing a risk of further spread. In response to this issue, while previous diagnosis and treatment guidelines relied solely on nucleic acid testing as the diagnostic criterion, the fifth edition of the guidelines now also incorporates CT imaging and clinical manifestations. These three aspects are combined to assess patient recovery.

NMPA Registration Department: Ensuring the Safety and Accessibility of Drugs and Medical Devices to Fully Support Epidemic Prevention and Control Needs

On February 8, the Department of Drug Registration of the National Medical Products Administration (NMPA) stated at a press conference held by the Joint Prevention and Control Mechanism that, in the context of epidemic prevention and control, the fundamental responsibilities and mission of drug regulatory authorities mainly encompass two aspects: first, to enforce strict supervision to ensure the safety of drugs and medical devices; and second, to accelerate the technical review of newly developed drugs and medical devices with potential efficacy, striving for their earliest possible market launch. It is reported that the NMPA successively approved the registration of seven nucleic acid testing products from seven enterprises on January 26, 28, and 31, thereby expanding the supply capacity of nucleic acid testing reagents for the novel coronavirus and effectively supporting the needs of epidemic prevention and control.

National Health Commission: Ensure Effective Internet-Based Diagnosis and Consultation Services During Epidemic Prevention and Control

On February 7, the General Office of the National Health Commission issued the “Notice on Doing a Good Job in Internet Diagnosis and Consultation Services During Epidemic Prevention and Control.” The notice stated that, to implement the decision-making arrangements of the CPC Central Committee and the State Council on strengthening the prevention and control of the novel coronavirus pneumonia epidemic, full advantage should be taken of the “Internet + Healthcare” model during epidemic prevention and control efforts to provide high-quality and convenient diagnosis and consultation services to the public.

AiDiWeiXin Secures RMB 30 Million in Funding to Support Preclinical Development of Novel Coronavirus Vaccine

Recently, vaccine developer Advaccine Biopharmaceuticals secured RMB 30 million in financing from Pengyao Environmental Protection, a publicly listed company. The funds will be used to support the research, development, and production of vaccines and pharmaceuticals related to the prevention and control of the novel coronavirus (SARS-CoV-2). Advaccine has currently completed the design of its DNA vaccine and rapidly produced vaccine candidates, with subsequent experimental work underway. Preclinical development is expected to be completed within four to six months, at which point the company will apply to enter clinical trials.

Kelun Pharmaceutical’s Tirofiban Hydrochloride and Sodium Chloride Injection Approved for Market Launch

Recently, Sichuan Kelun Pharmaceutical Co., Ltd. obtained the Drug Registration Approval issued by the National Medical Products Administration for the chemical drug “Tirofiban Hydrochloride and Sodium Chloride Injection.” Tirofiban Hydrochloride and Sodium Chloride Injection is an antiplatelet agent developed by Merck & Co., indicated for adult patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who have experienced their last episode of chest pain within 12 hours and present with electrocardiogram changes and/or elevated cardiac enzymes, to prevent early myocardial infarction; and for patients with acute myocardial infarction scheduled to undergo primary percutaneous coronary intervention (PCI), to reduce the incidence of major adverse cardiovascular events.

Conba’s Wholly Owned Subsidiary’s Drug Passes Generic Drug Consistency Evaluation

On February 10, Conba Pharmaceutical issued an announcement stating that its wholly-owned subsidiary, Hangzhou Conba Pharmaceutical Co., Ltd., had received the "Approval for Supplemental Drug Application" issued by the National Medical Products Administration (NMPA) for Tamsulosin Hydrochloride Sustained-Release Capsules. The drug has passed the consistency evaluation for generic drugs. Tamsulosin Hydrochloride Sustained-Release Capsules are indicated for the treatment of benign prostatic hyperplasia (BPH). As a selective α1-adrenergic receptor blocker, it is used to treat voiding dysfunction caused by prostatic hyperplasia.

Huahai Pharmaceutical’s Sertraline Hydrochloride Tablets Pass Consistency Evaluation

Recently, Zhejiang Huahai Pharmaceutical Co., Ltd. announced that it had received the "Approval for Supplementary Drug Application" for Sertraline Hydrochloride Tablets, approved and issued by the National Medical Products Administration (NMPA). Sertraline Hydrochloride Tablets, developed by Pfizer Inc., are primarily indicated for the treatment of symptoms associated with depression and obsessive-compulsive disorder (OCD).

Hengrui Medicine’s Class 1 New Drug SHR0302 Tablets Approved for Clinical Trials, Intended for the Treatment of Alopecia Areata

On February 10, the Center for Drug Evaluation (CDE) Clinical Trial Implicit Approval List showed that SHR0302 tablets, developed by Risheng Biopharmaceuticals, a subsidiary of Hengrui Medicine, received clinical trial approval for the treatment of alopecia areata. SHR0302 is a JAK1 inhibitor independently developed by Hengrui Medicine. It selectively inhibits JAK kinases, blocks the JAK/STAT signaling pathway, and regulates intracellular activities, making it an important therapeutic agent for autoimmune diseases in clinical practice.

Rare Disease Therapy Company Zogenix’s New Anti-Epileptic Drug Meets Primary Endpoint in Phase 3 Trial

Recently, Zogenix, a company dedicated to developing therapies for rare diseases, announced that its oral fenfluramine, Fintepla (ZX008), met the primary endpoint in a pivotal Phase 3 trial in patients with Lennox-Gastaut syndrome (LGS). Compared with the placebo group, patients in the Fintepla treatment group achieved a statistically significant reduction in seizure frequency from baseline.

Guangshengtang Launches R&D of Anti-2019-nCoV Drugs

On February 10, Guangshengtang announced in an evening statement that on February 6, the company submitted a complete set of ethical approval documents for two investigator-initiated clinical studies on the use of generic drugs G2 and G3 in the treatment of novel coronavirus pneumonia to Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, located in the epicenter of the outbreak. On February 7, the investigator-initiated clinical trial titled “A Small-Sample Pilot Study of Generic Drugs G2 or G3 in the Treatment of Mild to Moderate Novel Coronavirus Pneumonia” received ethical approval and is currently proceeding in an orderly manner.

Two Chinese Pharmaceutical Companies Enter the Top 25 Global Pharmaceutical Brand Value Rankings for the First Time

Recently, the UK-based brand valuation consultancy Brand Finance released its 2020 ranking of the top 25 most valuable pharmaceutical brands worldwide. Johnson & Johnson took the top spot, with its brand value decreasing by 11% from 2019 to $10.9 billion, yet it remains the most valuable brand in the pharmaceutical industry. This year, the list of the most valuable pharmaceutical brands was expanded to 25 for the first time. Sinopharm and Shanghai Pharmaceuticals (SPH) became the only two Chinese pharmaceutical companies included on the list. In total, three Asian pharmaceutical companies, including Takeda, made it into the global rankings.

Kangtai Biological Products and Advaccine Sign Strategic Cooperation Agreement to Develop COVID-19 DNA Vaccine

On February 9, Kangtai Biological Products announced that it had signed a "Strategic Cooperation Agreement" with Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. The two parties will form a working group to coordinate resources from all sides, jointly develop a COVID-19 DNA vaccine, and address issues arising in preclinical research, clinical trial applications, and clinical trials.

Luye Pharma and Cipla Medpro Reach Agreement on Exclusive Distribution and Promotion Rights for Seroquel in South Africa and Other Regions

On February 10, Luye Pharma Group announced that it had entered into an agreement with Cipla Medpro South Africa (Pty) Limited (“Cipla Medpro”), a wholly-owned subsidiary of the global pharmaceutical company Cipla Limited, granting Cipla Medpro the exclusive rights to distribute and promote the antipsychotic drugs Seroquel® and Seroquel XR® in South Africa, Namibia, and Botswana.

U.S. Cancer Trial Confirms Safety of CRISPR-Edited Immune Cells

Recently, according to a report by the UK’s New Scientist website, U.S. scientists injected CRISPR-edited immune cells into three patients with advanced-stage cancer and observed no serious side effects. Researchers stated that this is the first trial of its kind in the United States and the first CRISPR-based cancer trial worldwide to publish results. The findings are encouraging and are expected to pave the way for more future trials.