Abbisko Completes $70M Series C Financing; Ascletis Announces Positive Initial Clinical Results of Danoprevir for COVID-19

New York to Partner with Undisclosed Pharmaceutical Company on Coronavirus Plasma Trial

On March 24, it was reported that New York City will launch a clinical trial using plasma from patients who have recovered from COVID-19 caused by the novel coronavirus. The plasma, containing antibodies against the virus, will be administered to critically ill patients. According to a report by Forbes magazine on Monday, the Governor of New York State stated that this approach has “shown promising preliminary results in stimulating the immune system to fight the disease.” The state will collaborate with an as-yet-undetermined pharmaceutical company to conduct this trial.

Tencent Establishes $100 Million Global Fund to Fight the Epidemic

On March 24, Tencent announced the establishment of a $100 million “Tencent Global Epidemic Prevention Fund,” following its earlier creation of a RMB 1.5 billion epidemic response fund, to help combat the increasingly severe global outbreak of the novel coronavirus. Initially, the fund will focus on procuring and donating medical supplies, such as personal protective equipment (PPE) for healthcare workers and essential medical materials required by hospitals and frontline medical staff.

Ascletis Pharma Publishes Positive Results from First Clinical Study of Danoprevir for COVID-19

On March 25, Ascletis Pharma Inc. announced that the first clinical study results of GanoWei® (danoprevir) for the treatment of both treatment-naïve and treatment-experienced patients with novel coronavirus pneumonia were published on the medical preprint server medRxiv. The study results demonstrated that danoprevir combined with ritonavir exhibited good safety and tolerability in all patients. After 4–12 days of treatment with danoprevir combined with ritonavir, all 11 enrolled patients with moderate novel coronavirus pneumonia (including 2 treatment-naïve patients and 9 treatment-experienced patients) met the standard criteria for hospital discharge.

MIIT: New technologies such as AI are applied to the R&D of vaccines and new drugs

On March 25, the State Council’s Joint Prevention and Control Mechanism held a press conference in Beijing. Xie Shaofeng, Director of the Department of Information Technology Development at the Ministry of Industry and Information Technology, stated that in supporting scientifically grounded epidemic prevention and control, certain medical institutions have leveraged new technologies such as the internet, big data, cloud computing, and artificial intelligence to carry out precise and efficient work in epidemic monitoring and analysis, virus source tracing, patient tracking, and community management. The application of artificial intelligence, big data, 5G, and other technologies has accelerated the pace of viral diagnostic testing, vaccine and new drug development, and prevention, control, and treatment efforts, thereby enhancing the efficiency of the fight against the epidemic. Additionally, some manufacturers of medical supplies have relied on internet platforms to achieve precise matching of supply and demand for medical and epidemic prevention materials, as well as to manage efficient production, coordinated allocation, and recycling.

Abbisko Therapeutics Completes $70 Million Series C Financing to Advance Four Clinical-Stage Pipeline Programs

On March 25, Shanghai Abisko Biotherapeutics announced the completion of a $70 million Series C financing round, led by Temasek, with additional participation from existing investors Qiming Venture Partners, CCB Capital, GIC, Lilly Asia Ventures, CICC Capital, and ZenCapital. The proceeds from this round will be used to support the advancement of the company’s four ongoing clinical programs and the research and development of multiple preclinical projects.

Biotech Company Apexigen Completes $65 Million C+ Round of Financing to Support Clinical Development of Immunotherapy APX005M

On March 24, biotechnology company Apexigen announced the completion of a $65 million Series C+ financing round. The round was led by Decent Capital and new investor Oceanpine Capital, with participation from other existing and new investors. The proceeds will be used to support the ongoing clinical development of its lead immunotherapy candidate, APX005M, a monoclonal antibody targeting CD40. The funding will also be allocated to expanding Apexigen’s therapeutic pipeline, including advancing at least one novel proprietary immunotherapy candidate into Phase I clinical development.

Jingfeng Pharmaceutical’s Ranolazine Extended-Release Tablets Receive U.S. ANDA Approval

On March 24, Jingfeng Pharmaceutical announced that its controlled subsidiary, Sungen Pharma (Shangjin), had received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Ranolazine Oral Extended-Release Tablets had been approved. Ranolazine can reduce the incidence of arrhythmias, including ventricular arrhythmias, new-onset atrial fibrillation, and bradycardia caused by coronary artery disease, and can also lower glycated hemoglobin levels in patients with diabetes.

Northeast Pharmaceutical’s Amlodipine Maleate API and Others Receive “Approval for Supplementary Drug Application”

On March 24, 2020, Northeast Pharmaceutical Group announced that it had received the “Notice of On-site GMP Inspection Results for Drugs” from the Liaoning Provincial Medical Products Administration, and that its active pharmaceutical ingredient (API) amlodipine besylate had passed the on-site inspection. The company also received the “Approval Documents for Supplementary Drug Applications” for the APIs amlodipine besylate, vitamin B1, and vitamin C, which were approved and issued by the Liaoning Provincial Medical Products Administration.

Helsinn’s Combination Chemotherapy Antiemetic Akynzeo Approved by the EU

On March 25, pharmaceutical company Helsinn announced that the European Commission (EC) has approved the intravenous (IV) formulation of Akynzeo (fosnetupitant 235 mg/palonosetron 0.25 mg) for the prevention of chemotherapy-induced nausea and vomiting (CINV). The approval of the IV formulation of Akynzeo provides an alternative route of administration for patients and healthcare providers in Europe.

Six Drugs, Including Maijing Cod Liver Oil, from Baiyunshan Subsidiary Receive Drug Re-registration Approval

On March 24, Baiyunshan announced that its controlling subsidiary, Xingqun Pharmaceutical, had received the Drug Re-registration Approval issued by the Guangdong Provincial Medical Products Administration for six drugs, including Malt Extract Cod Liver Oil. The relevant drugs are: Malt Extract Cod Liver Oil, Liuhe Vitamin Pills, Pentoxyverine Citrate Syrup, Vitamin A and E Soft Capsules, Paracetamol Oral Solution, and Shengmai Yin (Codonopsis Formula).

Baiyunshan Subsidiary Receives Drug Registration Approval for Clindamycin Phosphate for Injection

On March 24, Baiyunshan announced that its controlling subsidiary, Tianxin Pharmaceutical, had received the Drug Registration Approval issued by the National Medical Products Administration (NMPA). The approved drug, Clindamycin Phosphate for Injection, is primarily indicated for the treatment of severe bacterial infections caused by susceptible anaerobic bacteria. It is also used for severe bacterial infections caused by susceptible organisms, including Streptococcus, Streptococcus pneumoniae, and Staphylococcus, and is the drug of choice for treating osteomyelitis caused by Staphylococcus aureus.

Jianyou Shares’ Milrinone Injection USP Receives U.S. Registration Approval

On March 25, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“Jianyou Shares”) announced that it had recently received an approval notice from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Milrinone Injection, USP. To date, the company has incurred approximately RMB 13.3325 million in research and development expenses for the Milrinone Injection, USP project.

Sihuan Pharmaceutical’s Pediatric Compound Amino Acid Injection Approved by China’s NMPA

Recently, Sihuan Pharmaceutical announced that the Group’s Pediatric Compound Amino Acid Injection (18AA-II) has received a drug registration approval from the National Medical Products Administration (NMPA). This medication is a compound formulation composed of amino acids, specifically containing 18 common proteinogenic amino acids and taurine. According to available data, this product is an intravenous parenteral nutrition infusion indicated for: premature infants, low-birth-weight infants, and neonates unable to take in sufficient protein orally due to various causes; pediatric patients in hypermetabolic states resulting from various traumas, such as burns, external injuries, and post-surgical conditions; and pediatric patients with acute or chronic malnutrition who are unable to consume food orally or have inadequate oral intake.

Pfizer’s Eucrisa Ointment for Atopic Dermatitis Approved by FDA for Pediatric Patients Aged 3 Months and Older

Recently, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Eucrisa (crisaborole, 2% ointment), allowing its use in treating mild-to-moderate atopic dermatitis in pediatric patients aged 3 to 24 months. In China, Eucrisa was included in the “Second Batch of Clinically Urgent Overseas New Drugs” list on the grounds that “atopic dermatitis is a chronic, relapsing inflammatory skin disease with limited treatment options currently available; this product provides an effective therapeutic option with a novel mechanism of action for patients who are intolerant or unresponsive to existing therapies.”

Salubris’ Original Novel Drug CS12192 Clinical Trial Application Accepted

On March 23, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the Investigational New Drug (IND) application for CS12192, a Class 1 innovative original drug developed by Chipscreen Biosciences for the treatment of autoimmune diseases and other related conditions such as graft-versus-host disease (GVHD). CS12192 is a highly selective JAK3 kinase inhibitor independently developed by Chipscreen Biosciences, with global compound patent authorization. It also partially inhibits JAK1 and TBK1 kinases.

Biotech Company Rubius Shifts Red Blood Cell Therapy Focus to Cancer and Autoimmune Diseases

Recently, following the failure of RTX-134 in its Phase Ib clinical trial for the treatment of phenylketonuria (PKU), Rubius Therapeutics announced that it would halt clinical trials of its red blood cell (RBC) therapies for PKU and other rare diseases, shifting its focus to oncology and autoimmune diseases. RTX-240 is a cell therapy product that simultaneously expresses the natural ligand of 4-1BB and IL-15TP (a fusion of IL-15 and IL-15Rα) on the surface of red blood cells, theoretically enabling the concurrent activation of T cells and NK cells. The FDA has approved the Investigational New Drug (IND) application for RTX-240, and Rubius will soon initiate a Phase I clinical trial for the treatment of solid tumors.

CSPC Ouyi’s Generic Apremilast Tablets Marketing Application Accepted by CDE

Recently, CSPC Ouyi’s Class 3 generic marketing application for apremilast tablets was accepted by the Center for Drug Evaluation (CDE) and is currently under review. Apremilast tablets are a phosphodiesterase-4 (PDE-4) inhibitor developed by Celgene Corporation in the United States and marketed under the brand name Otezla. First launched in 2014, the product has been approved globally for three therapeutic indications: treatment of adult patients with moderate to severe plaque psoriasis; treatment of adult patients with active psoriatic arthritis; and treatment of oral ulcers associated with Behçet’s disease in adults.

PreparationNovavax’s Quadrivalent Nanoparticle Influenza Vaccine NanoFlu Achieves Success in Pivotal Phase III Trial

Recently, pharmaceutical company Novavax announced that its quadrivalent influenza nanoparticle vaccine, NanoFlu, met both primary and secondary endpoints in a pivotal Phase III clinical trial, with data showing statistically significant differences. Novavax will submit a Biologics License Application (BLA) for NanoFlu in the United States under the FDA’s Accelerated Approval pathway.

Hengrui Medicine’s Abiraterone Acetate Tablets (I) Approved for Clinical Trials

On March 25, Hengrui Medicine announced that it had recently received the “Clinical Trial Notice” approved and issued by the National Medical Products Administration (NMPA) for Abiraterone Acetate Tablets (I). The indicated use is in combination with prednisone or prednisolone for the treatment of: metastatic castration-resistant prostate cancer (mCRPC); and newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC), including patients who have not received prior endocrine therapy or have received endocrine therapy for no more than three months.

Merck’s Bispecific Antibody M7824 Approved for Clinical Trials in China, Indicated for Cervical Cancer

On March 24, the Center for Drug Evaluation (CDE) list of implied clinical trial approvals indicated that Merck’s bispecific antibody M7824 (MSB0011359C) had received approval for clinical trials, with cervical cancer as the indication. Currently, M7824 is undergoing concurrent clinical studies for multiple cancer types, among which the indication for biliary tract cancer (BTC) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). Existing clinical data have demonstrated favorable outcomes for M7824 in various refractory cancers, including advanced non-small cell lung cancer (NSCLC), human papillomavirus (HPV)-associated cancers, biliary tract cancers, and gastric cancer.

Hengrui Medicine's Fluzoparib Capsules Approved for Clinical Trials to Treat Advanced Pancreatic Cancer

On March 24, Hengrui Medicine’s Class 1 new drug, fluzoparib capsules, received clinical trial approval for the treatment of advanced pancreatic cancer in combination with mFOLFIRINOX chemotherapy, followed by sequential maintenance therapy with fluzoparib monotherapy. Currently, there are 19 concurrent clinical trials of fluzoparib underway, including combinations with PD-L1 inhibitors, PD-1 inhibitors, and abiraterone.

AveXis Announces Positive Data for Zolgensma in the Treatment of Spinal Muscular Atrophy

On March 24, pharmaceutical company AveXis announced the latest clinical trial data for its gene therapy, Zolgensma. The data showed that in the pivotal STR1VE-US clinical trial, not only did 91% of patients with severe type 1 spinal muscular atrophy (SMA) achieve the primary endpoint of event-free survival, but 9 out of 22 patients also met the more stringent criterion of “thriving.” This criterion assesses children’s ability to swallow, feed, and maintain normal body weight. The therapeutic effects of Zolgensma can last for more than five years after a single administration.

AmoyDx and Johnson & Johnson Enter into Strategic Partnership for Companion Diagnostics

Recently, AmoyDx has entered into a strategic partnership with multinational pharmaceutical company Johnson & Johnson for companion diagnostics. Under the agreement, AmoyDx will leverage its proprietary next-generation sequencing (NGS) technology platform to facilitate the variation registration of Vihuijian®, expand the scope of companion diagnostics, and support Johnson & Johnson’s oncology product portfolio.

Diagnostic Technology Company SkylineDx Announces Collaboration with Biotechnology Company BioInvent

On March 24, SkylineDx, a diagnostics company, announced a collaboration with BioInvent, a biotechnology company, to characterize the gene expression and immune profiles of tumors in patients before and after treatment with BI-1206. BI-1206 is BioInvent’s lead therapeutic candidate for patients with non-Hodgkin lymphoma and solid tumors.

Biopharmaceutical Company Cytomx Therapeutics Secures $80 Million to Initiate Development of Anti-Cancer Drugs with Astellas

On March 24, it was reported that biopharmaceutical company Cytomx Therapeutics announced a collaboration with Astellas Pharma to develop novel cancer immunotherapies based on its antibody technology. According to the terms of the deal announced on Monday evening, Astellas will pay Cytomx Therapeutics an upfront fee of $80 million. South San Francisco-based Cytomx will conduct and fund research until candidate drugs are selected. Astellas will provide funding for preclinical and clinical studies.

Bayer and Curadev Reach €250 Million Collaboration to Co-Develop Small-Molecule STING Antagonists

On March 23, Bayer and Indian pharmaceutical company Curadev announced a research collaboration and licensing agreement for a small-molecule stimulator of interferon genes (STING) antagonist program, aiming to jointly develop novel therapies for pulmonary diseases, cardiovascular diseases, and other inflammatory conditions. Under the agreement, Bayer has obtained exclusive global rights to a series of novel small-molecule inhibitors of the STING signaling pathway from Curadev. Curadev will receive an upfront payment from Bayer, as well as funding during the early research phase. Additionally, Curadev is eligible to receive milestone payments totaling more than €250 million for preclinical research, clinical development, and commercialization, along with single-digit royalties based on net sales.  

WuXi AppTec Announces 2019 Financial Results: Revenue Reaches RMB 12.872 Billion, a Year-on-Year Increase of 33.9%

On March 24, WuXi AppTec released its 2019 annual report. The company achieved operating revenue of RMB 12.872 billion, a year-on-year increase of 33.9%; adjusted Non-IFRS net profit attributable to shareholders of the parent company amounted to RMB 2.407 billion, up 38.2% year on year; diluted adjusted Non-IFRS earnings per share were RMB 1.46, representing a 19.7% year-on-year growth.

《Nat Biotechnol》: Researchers Discover New CAR Macrophage Therapy to Combat Solid Tumors

Recently, the journal Nature Biotechnology reported a novel cancer therapy: CAR macrophages (CAR-Ms), which involve engineering human macrophages using chimeric antigen receptor (CAR) technology to enable them to directly phagocytose tumors. This study was conducted by researchers at the Perelman School of Medicine, University of Pennsylvania.