Remdesivir 'Effective in Wuhan' Claim Debunked as Three Biotech Firms Surge on Nasdaq Debut

The claim that the antiviral drug remdesivir showed “significant efficacy” in Wuhan is a rumor

On February 7, 2020, in response to rumors circulating online that the antiviral drug remdesivir had shown “significant efficacy” in Wuhan, Professor Cao Bin, Vice President of China-Japan Friendship Hospital and the lead investigator for the drug’s clinical trials in Wuhan, stated that such claims were false. When asked by reporters, Professor Cao remarked, “The clinical study has only just begun; how could we possibly know the results?” He emphasized that scientific research requires time.

Sanjing Pharmaceutical Launches Clinical Trial of Shuanghuanglian Oral Liquid for the Treatment of Novel Coronavirus Infection

On February 7, the Chinese Clinical Trial Registry announced that Harbin Pharmaceutical Group Sanjing Pharmaceutical Co., Ltd. had initiated a randomized, open-label, parallel-controlled, multicenter clinical trial to evaluate the efficacy and safety of Shuanghuanglian Oral Liquid in the treatment of novel coronavirus-infected pneumonia (Registration No.: ChiCTR2000029605). The principal investigators are Wang Daowen and Zhao Jianping, with Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology serving as the lead implementing institution.

Gene Editing Company Beam Therapeutics Lists on Nasdaq

On February 6, 2020 (U.S. time), gene-editing technology company Beam Therapeutics made its Nasdaq debut. The company issued a total of 10,637,500 shares at an offering price of $17, the top end of its pricing range, raising over $180 million. On its first day of trading, the stock opened at $24, up 41.18% from the offering price. Beam’s share price ultimately closed at $18.75, marking a first-day gain of 10.29%.

CRO Giant PPD Returns to Nasdaq After Going Private

On February 6, 2020 (U.S. time), PPD, a giant U.S. CRO, went public again following its privatization. In this offering, PPD issued 60 million shares at $27 per share, the top end of the pricing range, raising a total of $1.62 billion. The stock opened at $31 on its first day of trading, up 14.81%. It then eased slightly to close at $30, representing an 11.11% gain. PPD’s current market capitalization stands at $10.18 billion, successfully surpassing the $10 billion mark.

AI-Driven Drug Discovery Firm Schrödinger Lists on U.S. Stock Market, Surging 68.47% on First Day

On February 7, 2020, Eastern Time, Schrödinger, a global leader in molecular simulation technology and enterprise software solutions that has received consecutive investments from Bill Gates (hereinafter referred to as “Schrödinger”), officially listed on the NASDAQ under the ticker symbol SDRG. The company issued a total of 10 million shares at $17 per share, raising $170 million. Following its market debut, the stock price surged dramatically, reaching an intraday high of 82.35% before closing at $28.64, representing a gain of 68.47%.

Genetron Health’s 8-Gene Lung Cancer Kit and GENETRON S2000 Gene Sequencer Approved for Market Launch

On February 5 and 6, 2020, Genetron Health’s GENETRON S2000 Gene Sequencer (NMPA Registration No. 20203220081, hereinafter referred to as “GENETRON S2000”) and Genetron Health’s Human 8-Gene Mutation Combined Detection Kit (Semiconductor Sequencing Method) (NMPA Registration No. 20203400072, hereinafter referred to as “Genetron Lung Cancer 8-Gene Kit”) were separately approved for market launch by the National Medical Products Administration (NMPA). To date, leveraging its proprietary patented technologies such as the “One-Step” method, Genetron Health has obtained approval for seven instruments and kits across its three major technology platforms—NGS, dPCR, and qPCR—that are tailored to China’s clinical molecular testing environment. These efforts aim to enhance and ensure the accessibility of high-tech solutions for large-scale sample testing, thereby benefiting a broader patient population.

BioAlliance’s Valsartan and Amlodipine Tablets Approved for Market Launch

On February 6, the National Medical Products Administration (NMPA) approved the marketing application for Valsartan and Amlodipine Tablets (I) (CYHS1800095), submitted by Beijing Bio-Pharmaceutical Co., Ltd. under the new Class 4 category. The NMPA has arranged for the issuance of the drug approval document. Bio-Pharmaceutical has become the first domestic manufacturer to launch a generic version of this classic combination antihypertensive medication. Developed by Novartis, Valsartan and Amlodipine Tablets are a single fixed-dose combination tablet comprising valsartan, an angiotensin II receptor blocker (ARB), and amlodipine, a calcium channel blocker. The product is indicated for patients whose blood pressure is not adequately controlled with monotherapy of either valsartan or amlodipine.

Zhejiang Medicine’s Norfloxacin Tablets Are the First to Pass the Consistency Evaluation

Recently, Zhejiang Medicine Co., Ltd. received the "Approval for Supplementary Drug Application" issued by the National Medical Products Administration (NMPA) for Norfloxacin Tablets (0.1g), approving the drug’s passage of the consistency evaluation of quality and efficacy for generic drugs. Norfloxacin is a quinolone antibiotic indicated for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid fever, and other Salmonella infections caused by susceptible organisms.

Wanbangde Clozapine Tablets Pass Consistency Evaluation

On February 7, Wanbangde Pharmaceutical, a wholly-owned subsidiary of Wanbangde New Materials, recently received the "Drug Supplemental Application Approval" from the National Medical Products Administration (NMPA) for Clozapine Tablets. This product has passed the consistency evaluation of quality and efficacy for generic drugs. Clozapine Tablets are primarily indicated for treatment-resistant schizophrenia and are listed as a Class A variety in the National Reimbursement Drug List (2019 Edition) and included in the National Essential Medicines List (2018 Edition). To date, Wanbangde Pharmaceutical’s Clozapine Tablets are the second in China to pass the consistency evaluation.

Shijiazhuang No. 4 Pharmaceutical Group’s Doxofylline Injection Passes Consistency Evaluation

On February 6, Shijiazhuang No.4 Pharmaceutical Group Co., Ltd. (02005) announced that the Group had obtained the drug production registration approval from the National Medical Products Administration (NMPA) for Doxofylline Injection (10ml: 0.1g) in polypropylene ampoule packaging. This product passed the national review and approval process, demonstrating consistency in quality and efficacy with the originator drug, and is the first to receive production approval under Category 4 of the new classification system for chemical drugs.

Novo Nordisk’s Oral GLP-1 Diabetes Drug Rybelsus (Semaglutide Tablets) Poised for EU Approval

Recently, diabetes giant Novo Nordisk 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 Rybelsus (oral semaglutide) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes whose blood glucose levels are not adequately controlled. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final decision expected in early Q2 2020.

GlaxoSmithKline’s GSK2857916 Granted Accelerated Assessment by the EU EMA for the Treatment of Relapsed/Refractory Multiple Myeloma

Recently, GlaxoSmithKline (GSK) announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) submitted by the company. The MAA seeks approval for belantamab mafodotin (GSK2857916, at a dose of 2.5 mg/kg), a B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate (ADC), for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received multiple therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Roche’s Risdiplam Significantly Improves Motor Function in Phase III Clinical Trial for Type 2/3 SMA

Recently, at the 2nd International Congress on Spinal Muscular Atrophy Science and Clinical Practice held in Évry, France, Roche announced one-year data from Part 2 (the pivotal portion) of the Phase III SUNFISH trial evaluating risdiplam, an oral medication for spinal muscular atrophy (SMA). SUNFISH is the largest placebo-controlled trial ever conducted in patients with Type 2 or Type 3 SMA aged 2–25 years. The Part 2 study population represented a broad, real-world SMA population. Results showed that after one year of treatment, patients receiving risdiplam demonstrated significant improvements in motor function compared with those in the placebo group.

AI Drug Discovery Firm Exscientia’s First AI-Developed Drug to Enter Human Trials

On February 4, Exscientia, a UK-based startup from Oxford, announced that a drug entirely designed by artificial intelligence would enter clinical trials in humans. Reportedly, the drug is intended to treat obsessive-compulsive disorder (OCD), and thanks to the AI system, its development time was reduced from four and a half years to less than 12 months.

Sanofi Announces 2019 Financial Results: Net Revenues Reach €36.126 Billion, Up 4.8% Year-on-Year

On February 5, Sanofi announced its 2019 financial results, reporting net sales of €36.126 billion (+4.8%). By Global Business Unit (GBU), Specialty Care generated €9.195 billion (+22.4%), Primary Care generated €9.076 billion (-14.8%), China and Emerging Markets generated €7.437 billion (+6.4%), Consumer Healthcare generated €4.687 billion (-0.8%), and Vaccines generated €5.731 billion (+9.3%).

Seattle Genetics’ New HER2-Positive Breast Cancer Drug Tucatinib Files for Marketing Authorization in the EU

Recently, Seattle Genetics announced that the European Medicines Agency (EMA) has accepted and initiated a formal review of the Marketing Authorization Application (MAA) for the targeted anticancer drug tucatinib. The MAA seeks EU approval for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer who have previously received at least two anti-HER2 regimens, including patients with brain metastases.

Drug Discovery Company Insilico Accelerates COVID-19 Drug Development with AI, Designing Over 100 Novel Molecular Structures

On February 7, 2020, Insilico Medicine, an AI-driven drug discovery company, announced that it had designed the structure of a small-molecule inhibitor targeting the SARS-CoV-2 3CL protease using its proprietary AI drug development platform. Leveraging generative chemistry methods, the company can design numerous molecules with diverse properties by specifying desired molecular characteristics as generation conditions.

《Nature》: Study Reveals Molecular Features of RNA Alterations in Cancer

Recently, a research report published in the international journal Nature revealed the characteristics of RNA alterations in cancer. Cancer is a disease triggered by DNA mutations, which are induced by environmental factors or aging. Currently, researchers have rarely investigated how these genomic changes affect RNA variations. Further in-depth studies are needed to determine whether RNA alterations are the result of mutations and how they contribute to the onset and progression of cancer.

PNAS: Development of a Rapid Library Preparation Method for Transcriptome Sequencing Based on Tn5 Transposase

Recently, a joint research team led by Huang Yanyi and Xie Xiaoliang from Peking University, in collaboration with the research team of Wang Jianbin from Tsinghua University, published a paper in the Proceedings of the National Academy of Sciences (PNAS) of the United States. They developed a new rapid library preparation method for transcriptome sequencing based on Tn5 transposase. Compared with existing methods, this approach significantly simplifies the library preparation process and requires only minimal sample input. It is not only suitable for high-quality single-cell transcriptome sequencing but also holds great promise for substantially improving the sequencing quality and speed for various samples, including those of coronaviruses that are currently spreading rampant.