Bio-Thera Solutions Soars Nearly 100% on STAR Market Debut; Junshi Biotech Secures Tens of Millions in Pre-A Round for Novel Solid Tumor TIL Therapies

Deputy Minister of Science and Technology Xu Nanping: Three Drugs Are in Clinical Trials

On February 21, Xu Nanping, Vice Minister of the Ministry of Science and Technology, stated that three drugs are currently in clinical trials. The first is favipiravir, which underwent a controlled trial involving 80 cases in Shenzhen, with promising preliminary results. Experts have recommended further expanding the trial to evaluate its therapeutic efficacy in patients. The second is stem cell therapy; four critically ill patients who received this treatment have already been discharged, and plans are underway to expand the clinical trials. The third is remdesivir, for which in vitro experiments conducted by scientists have demonstrated strong inhibitory effects against the virus.

NHC Responds to Vaccine R&D Progress: Five Technical Routes Under Concurrent Investigation

On February 21, 2020, Zeng Yixin, Deputy Director of the National Health Commission, stated that vaccine development is a complex process. As SARS-CoV-2 is a novel virus, certain uncertainties remain. However, China has made significant advancements in vaccine research and development technologies, with a number of high-caliber R&D teams dedicated to tackling key challenges. The latest progress involves the simultaneous pursuit of five technological approaches: inactivated vaccines, genetically engineered recombinant subunit vaccines, adenovirus vector vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines. Several vaccine candidates have entered the animal testing phase.

Chinese Researchers Obtain Multiple Fully Human Antibodies, Making Convalescent Plasma Therapy More Stable and Reliable

On February 21, it was learned from East China Normal University that the biomedical team of its School of Life Sciences has identified multiple fully human antibodies capable of specifically binding to SARS-CoV-2 proteins. This means that future treatments using convalescent plasma will be safer. It was revealed that the neutralizing activity of these antibodies in blocking viral entry into cells will next be evaluated in the P3 laboratory of the State Key Laboratory for Diagnosis and Treatment of Infectious Diseases.

Chinese Academy of Agricultural Sciences Develops BVDV Reference Materials to Enhance Assurance for COVID-19 Vaccine Development

On February 19, it was reported that the Institute of Special Animal and Plant Sciences of the Chinese Academy of Agricultural Sciences has developed a “Bovine Viral Diarrhea Virus (BVDV) Nucleic Acid Reference Material” (BVDV Reference Material), which can be used for the detection of exogenous BVDV in bovine serum during vaccine development. Recently, the BVDV Reference Material has been awarded a Certification of Grading for Reference Materials by the State Administration for Market Regulation.

Elsevier Launches Global Map of Coronavirus Research Institutions and Researchers

On February 21, 2020, Elsevier launched a new global map of institutions and researchers studying coronaviruses. Based on Elsevier’s Scopus citation and abstract database, the map focuses on research related to coronavirus outbreaks and outbreak control. The map provides an overview of the distribution of relevant research institutions worldwide, particularly in China. Users can zoom in or out to focus on specific institutions and identify their researchers for in-depth analysis. The launch of this global map will provide researchers with more comprehensive and valuable information to better understand and study coronaviruses and keep abreast of scientific advances.

Bio-Thera Solutions Lists on STAR Market, Raising RMB 2 Billion with Nearly 80% Allocated to R&D

On February 20, Bio-Thera Solutions announced that the company was listed on the STAR Market on February 21, 2020, with an issue price of RMB 32.76 per share, raising approximately RMB 2 billion in proceeds. Currently, the company’s adalimumab biosimilar, BAT1406, has been approved for marketing since November 2019. In addition, there are 20 other products mainly under research and development, along with multiple pipeline projects at the preclinical stage.

Bio-Thera Solutions opened at RMB 60.00 today, representing an 83.15% increase over its issue price. The intraday high reached RMB 78.00, marking a surge of 138.10%. At the close, Bio-Thera Solutions’ share price remained elevated at RMB 60.20, up 83.76% from its issue price.

Junsaibio Completes Tens of Millions of RMB in Pre-A Financing, to Continue R&D of Multiple Novel TIL Cell Therapies

Shanghai Junsai Biotechnology Co., Ltd. Successfully Closes Tens of Millions of RMB in Pre-A FinancingRecently, Shanghai Junsai Biotechnology Co., Ltd. successfully completed its Pre-A financing round, raising tens of millions of RMB. The round was led by Yuanhe Origin, with Furon Investment participating as a co-investor. Joyo Capital served as the exclusive financial advisor for this financing round. According to Dr. Jin Huajun, the company’s founder, the funds raised will be utilized for the research and development of multiple novel tumor-infiltrating lymphocyte (TIL) cell therapies. Junsai Biotechnology is a globally leading innovator in novel cell therapies for solid tumors, dedicated to developing innovative TIL-based treatments and first-in-class/best-in-class cellular drug candidates for various recurrent and refractory tumors.

Tailing Pharmaceutical’s “Shusi” Passes Consistency Evaluation for the Treatment of Bipolar Disorder

On February 20, Addex Therapeutics announced that its subsidiary, Suzhou No.1 Pharmaceutical Co., Ltd., had received approval from the China National Medical Products Administration (NMPA) for the consistency evaluation of its combination drug “Shusi” (generic name: Quetiapine Fumarate Tablets), which is used to treat bipolar disorder. It is reported that “Shusi” is an independently developed product manufactured by Suzhou No.1 Pharmaceutical.

Bayer’s New Prostate Cancer Drug Darolutamide Proposed for Priority Review in China Marketing Application

On February 20, the CDE website indicated that ODM-201 (darolutamide), submitted by Bayer in China, was proposed for inclusion in the priority review program under Category I(3) for innovative drugs with significant therapeutic advantages. Darolutamide is a non-steroidal androgen receptor inhibitor (ARi) jointly developed by Bayer and Orion. Its unique chemical structure exhibits high affinity for receptor binding and potent antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells.

FDA Approves Three Drugs for Switch from Prescription to Over-the-Counter Status

Recently, the FDA approved the switch of three drugs from prescription (Rx) to over-the-counter (OTC) status. The three drugs are GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%), indicated for the temporary relief of arthritis pain; and Alcon’s Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution, 0.1%) and Pataday Once Daily Relief (olopatadine hydrochloride ophthalmic solution, 0.2%), indicated for the temporary relief of itchy and red eyes caused by pollen, ragweed, animal hair, or dander.

Ethical Approval Granted for Clinical Trial of Staidson’s BDB-001 Injection in the Treatment of COVID-19

On February 21, Staidson BioPharma announced that the Phase Ib clinical trial of BDB-001 injection for the treatment of COVID-19, jointly developed by the company and its wholly-owned subsidiary Defengrui, had been approved by the Ethics Committee of Hainan Third People’s Hospital. With preparatory work completed, the aforementioned clinical trial is set to commence shortly. The two indications for BDB-001 injection in this trial are: (1) reducing the incidence of severe pneumonia and acute respiratory distress syndrome (ARDS) in patients with novel coronavirus infection; and (2) treating severe pneumonia caused by novel coronavirus infection.

The FDA Announces the Establishment of a Dedicated Webpage Listing Pharmacogenomics-Related Information

On February 21, 2020, the FDA announced the establishment of a dedicated webpage listing information related to pharmacogenomics. On this page, the FDA cataloged 51 gene-drug interactions. Following evaluation, the FDA determined that sufficient scientific evidence supports the potential impact of these interactions on drug efficacy or safety, and recommended that physicians adjust drug selection and dosage when prescribing. The FDA stated that the information provided on this webpage is not exhaustive and will be continuously updated to provide accurate data on gene-drug interactions, thereby harnessing the potential of pharmacogenomics while safeguarding patient health.

Biotech Firm Heron’s New Non-Opioid Analgesic HTX-011 Receives 3-Month Extension of U.S. Review Period

Recently, biotechnology company Heron Therapeutics announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its New Drug Application (NDA) for HTX-011 (bupivacaine/meloxicam), a novel non-opioid analgesic for the management of postoperative pain, by three months. The new Prescription Drug User Fee Act (PDUFA) target date is June 26, 2020. HTX-011 is a long-acting, extended-release formulation comprising a fixed-dose combination of the local anesthetic bupivacaine and the anti-inflammatory agent meloxicam, indicated for the treatment of postoperative pain.

Teva’s Austedo Fails in Phase II/III Registration Trial for Tourette Syndrome

Recently, Teva Pharma announced the results of its Phase II/III ARTISTS 1 and Phase III ARTISTS 2 trials. Conducted in pediatric patients with moderate-to-severe Tourette syndrome (TS), these trials showed that Austedo (deutetrabenazine tablets) failed to meet the primary endpoint of reducing motor and vocal tics, as assessed by the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS), compared with placebo. Austedo is the first deuterated drug approved globally.

Hengrui Registers to Launch Phase I Clinical Study of SHR-1701 for Advanced Nasopharyngeal Carcinoma

On February 20, Hengrui Medicine registered the initiation of a Phase Ib clinical study to evaluate the safety and tolerability of SHR-1701 in patients with recurrent or metastatic nasopharyngeal carcinoma, with a planned enrollment of 40 participants. This open-label, non-randomized, single-arm domestic trial has safety as its primary endpoint. Secondary endpoints include objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

Humanwell Healthcare’s Class 3 Generic Drug Alfentanil Hydrochloride Is Set to Gain Market Approval

Recently, according to the NMPA website, the marketing application for Humanwell Healthcare’s Class 3 generic drug, Alfentanil Hydrochloride Injection (acceptance numbers: CYHS1700408, CYHS1700409, CYHS1700410, representing different specifications), is currently in the “under review” status. It is expected to be approved for marketing in the near future, becoming the first alfentanil product approved for launch in China. Alfentanil Hydrochloride Injection is a potent analgesic used during anesthesia, suitable for short-duration surgical procedures.

Chia Tai Tianqing's Application for New Indications of Edaravone and Sodium Chloride Injection Accepted

On February 20, China Biopharmaceutical announced that its subsidiary, Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd., had submitted an application to the National Medical Products Administration (NMPA) for a new indication of its neuroprotective agent “Edaravone and Sodium Chloride Injection” (brand name: Yibitan), and the application had been accepted. The newly applied indication is amyotrophic lateral sclerosis (ALS). According to data from Menet, sales of edaravone at public medical institutions in China exceeded RMB 5 billion in 2018.

OmniPharma Partners with Major Indian Pharmaceutical Company to Co-Develop an Inhaled Powder Aerosol Product

Recently, OmniMed announced a collaboration agreement with a major Indian pharmaceutical company active in global markets, particularly in Europe and the United States. The two parties will jointly develop an inhaled powder aerosol product, targeting the multi-billion-dollar market for COPD and asthma in the United States, Europe, and Canada. OmniMed will be responsible for the research, development, and production of this product.

Biopharmaceutical Company Immatics Collaborates with GlaxoSmithKline to Develop Novel TCR-T Cell Therapy

On February 21, 2020, the latest news revealed that biopharmaceutical company Immatics Biotechnologies GmbH is collaborating with GlaxoSmithKline (GSK) to develop novel adoptive cell therapies for various oncology indications. Under the strategic collaboration agreement, Immatics and GSK will jointly research and develop next-generation T-cell receptor (TCR) therapeutics focused on solid tumors. The initial plan involves autologous T-cell therapies, with the option to incorporate allogeneic cell therapies using Immatics’ ACTallo platform. According to the terms of the deal, GSK will pay Immatics an upfront fee of approximately $50 million for two initial programs. Immatics is also eligible to receive over $550 million in various commercial milestone payments, as well as additional royalties.