CStone Pharmaceuticals Announces NMPA Acceptance of New Drug Application for Avapritinib in Gastrointestinal Stromal Tumor

Pharmaceutical Company Bugworks Secures $7.5 Million in Funding to Advance Phase 1 Studies of Its GYROX Series of Intravenous Drugs

On April 23, 2020, Bugworks Research Inc., a global biopharmaceutical startup designing novel broad-spectrum antibiotics, announced the completion of a $7.5 million financing round. The round was led by UTEC (University of Tokyo Edge Capital Partners Co., Ltd.) and Global Brain from Japan, as well as Acquipharma Holdings from South Africa. To date, the company has raised $19 million, with existing investors including 3one4 Capital. This investment will enable Bugworks to complete Phase I studies of its GYROX series of intravenous drug candidates and advance the clinical development of its oral formulations.

Biotech Firm Myosana Completes $1 Million Seed Funding Round to Advance Its Non-Viral Gene Therapy

On April 22, biotechnology company Myosana Therapeutics announced the completion of a $1 million seed financing round, with CureDuchenne Ventures as the investor. The funds will be used to advance the development of its innovative non-viral gene therapy, aiming to deliver full-length dystrophin for the treatment of Duchenne muscular dystrophy (DMD).

Immunomedics’ ADC Drug Trodelvy for Triple-Negative Breast Cancer Receives FDA Accelerated Approval

On April 22, clinical-stage biopharmaceutical company Immunomedics announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for its antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies. Trodelvy is the first antibody-drug conjugate approved by the FDA for the treatment of triple-negative breast cancer, as well as the first approved antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (Trop-2).

Bayer’s Precision Oncology Drug Vitrakvi Approved in the UK for the Treatment of NTRK Fusion Solid Tumors

Recently, Bayer, the German pharmaceutical giant, received positive regulatory news in the UK for its precision oncology drug Vitrakvi (larotrectinib). The National Institute for Health and Care Excellence (NICE) has issued guidance approving Vitrakvi for use within the UK’s National Health Service (NHS) for pediatric and adult patients with solid tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions. Specifically, it is indicated for patients who are NTRK gene fusion-positive, have locally advanced or metastatic disease, or for whom surgical resection would likely result in severe morbidity, and who have no satisfactory alternative treatment options. Notably, Vitrakvi is the first “tumor-agnostic (histology-independent)” therapy made available to NHS patients in the UK through the Cancer Drugs Fund (CDF).

Harbin Pharmaceutical Group’s Amoxicillin Capsules Pass the Generic Drug Consistency Evaluation

On April 22, Harbin Pharmaceutical Group Co., Ltd. announced that its branch, Harbin Pharmaceutical Group General Pharmaceutical Factory, had received the "Approval for Supplementary Drug Application" issued by the National Medical Products Administration (NMPA) for two specifications of Amoxicillin Capsules. These two specifications have passed the consistency evaluation of quality and efficacy for generic drugs. Amoxicillin Capsules are commonly used oral beta-lactam anti-infective agents for the treatment of infections in various parts of the body caused by bacteria.

Harbin Pharmaceutical Group’s Ibuprofen Granules Pass the Generic Drug Consistency Evaluation

On April 22, Harbin Pharmaceutical Group Co., Ltd. announced that its branch, Harbin Pharmaceutical Group Shiyitang Pharmaceutical Factory, had received the "Approval for Supplementary Drug Application" issued by the National Medical Products Administration (NMPA) for Ibuprofen Granules, indicating that the drug has passed the Consistency Evaluation of Quality and Efficacy for Generic Drugs. Ibuprofen Granules are indicated for the relief of mild to moderate pain, such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, and dysmenorrhea, as well as fever caused by the common cold or influenza.

CStone Pharmaceuticals’ New Drug Application for Avapritinib, a Precision Targeted Therapy for Gastrointestinal Stromal Tumors, Accepted by the NMPA

On April 23, 2020, CStone Pharmaceuticals (Suzhou) Co., Ltd. announced that the National Medical Products Administration (NMPA) had accepted its new drug application (NDA) for avapritinib, a precision targeted therapy for gastrointestinal stromal tumors (GIST). The application covers two indications: treatment of adult patients with unresectable or metastatic GIST harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations (including the PDGFRA D842V mutation), and treatment of adult patients with unresectable or metastatic GIST who have received three or more prior lines of therapy. Avapritinib is a potent, highly selective, investigational oral inhibitor targeting KIT and PDGFRA gene mutations. This marks the first NDA accepted by the NMPA for CStone Pharmaceuticals.

FDA Accepts New Drug Application for Terlipressin, a Treatment for Type 1 Hepatorenal Syndrome, from Mallinckrodt Pharmaceuticals

Recently, global specialty pharmaceutical company Mallinckrodt announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for terlipressin, a treatment for type 1 hepatorenal syndrome (HRS-1). The company had previously announced on March 17 that it had completed the rolling submission of the terlipressin NDA. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 12, 2020. If approved, terlipressin would become the first drug in the United States for the treatment of adult patients with HRS-1.

Biopharmaceutical Company Myovant Announces Relugolix, an Innovative Therapy for Endometriosis, Meets Phase 3 Clinical Trial Endpoints

On April 23, 2020, biopharmaceutical company Myovant Sciences announced that its investigational relugolix combination therapy met the primary efficacy endpoint and six key secondary endpoints in the Phase 3 SPIRIT2 trial evaluating patients with endometriosis-associated pain. Furthermore, in a separate Phase 1 clinical study assessing ovulation suppression, the relugolix combination regimen achieved 100% ovulation inhibition in 67 healthy women, with 100% resumption of ovulation or menstruation following discontinuation of treatment.

Novartis Announces Kymriah Granted RTA Designation by FDA, Initiating Research into New Indications for Lymphoma Patients

On April 22, Novartis announced that the U.S. Food and Drug Administration (FDA) had granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah for a new indication under investigation: the treatment of patients with relapsed or refractory follicular lymphoma. As the world’s first approved CAR-T cell therapy, Kymriah would see its third indication if this potential approval for relapsed or refractory follicular lymphoma is granted, joining its existing approvals for relapsed or refractory acute lymphoblastic leukemia in children and young adults, and relapsed or refractory diffuse large B-cell lymphoma in adults.

Novartis Announces Phase 3 REACH2 Study Data for Jakavi in Patients with GvHD

On April 22, Novartis announced data from the Phase III REACH2 study, demonstrating that Jakavi can improve outcomes for patients with steroid-refractory acute graft-versus-host disease (GvHD) who have failed first-line therapy. The Phase III REACH2 study results showed that at the primary endpoint of Day 28, the overall response rate was 62% in the Jakavi group, compared with 39% in the best available therapy group. Additionally, no new adverse reactions were observed in the REACH2 study, and treatment-emergent adverse events were consistent with the known safety profile of Jakavi.

Pfizer and BioNTech Announce German Government Approval for Clinical Trials of mRNA COVID-19 Vaccine

On April 23, 2020, BioNTech and Pfizer announced that the German regulatory authority, the Paul-Ehrlich-Institut, had approved the Phase 1/2 clinical trial of BioNTech’s BNT162 vaccine candidate for the prevention of novel coronavirus infection. This trial marks the first clinical study of a COVID-19 vaccine candidate initiated in Germany and is part of the global development program for BNT162. Pfizer and BioNTech will also conduct BNT162 trials in the United States, with regulatory approval expected shortly. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, with both companies aiming to initiate clinical trials in the country.

Aimab Therapeutics and QIMR Berghofer Medical Research Institute Partner to Develop Novel Bispecific Antibody Drugs Targeting New Targets

On April 23, 2020, Akeso Biopharma announced a collaboration with QIMR Berghofer Medical Research Institute, a non-profit research organization headquartered in Brisbane, Australia, to explore the combination and application of novel targets using Akeso’s bispecific antibody platform, FIT-Ig®. Under the terms of the agreement, Akeso Biopharma will obtain an exclusive license to novel target combinations identified by Professor Bill Dougall and Professor Mark Smyth at QIMR Berghofer. Akeso’s novel bispecific antibodies will be tested using QIMR Berghofer’s preclinical models. Financial details of the agreement were not disclosed.

Biogen Announces Delay of New Alzheimer’s Drug Aducanumab Marketing Application to Q3 2020

On April 22, biotechnology company Biogen announced that the submission of the Biologics License Application (BLA) for aducanumab would not be completed until Q3 2020. Biogen plans to further communicate with the FDA regarding the marketing approval of aducanumab through a Type C meeting and is currently preparing relevant materials for the pre-BLA meeting scheduled for summer 2020.

Volunteers in Moderna's COVID-19 Vaccine Trial Receive Second Dose

On April 22, Seattle volunteers who received the first dose in the Phase I human vaccine trial launched last month were administered their second dose, indicating that early-stage vaccine trials are progressing smoothly. The vaccine, named mRNA-1273, was jointly developed by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the American biotechnology company Moderna. Dr. Lisa Jackson of Kaiser Permanente, who is leading the study, explained that the two-dose regimen was adopted because SARS-CoV-2 is a novel virus to which no one had been exposed prior to its emergence in December.

US Media: Study Shows Nasal Spray May Be Used to Treat COVID-19

On April 21, according to a report by the U.S. website Newsweek, representatives of a Utah-based pharmaceutical company collaborated with the Antiviral Institute at Utah State University and respiratory specialist Dr. Gustavo Ferrer to evaluate the effects of CPM on the novel coronavirus. This antihistamine, combined with a nasal spray currently developed as an anti-allergy medication, was introduced into infected cell samples. After 25 minutes of exposure, data showed that the viral load in the cell samples decreased to a level considered statistically significant by the researchers.

BMJ: Novel coronavirus persists longer in feces than in the respiratory tract, and viral shedding is slower in men than in women

On April 21, a study published online in the BMJ, a top-tier international medical journal, presented new findings by multiple teams, including those from Zhejiang University School of Medicine, on the duration and viral load of SARS-CoV-2 in various tissue samples from confirmed patients. The research indicated that the virus persisted significantly longer in fecal samples than in respiratory and serum samples, with the peak viral load in feces occurring later.

Science: Chinese Scientists Design Antiviral Candidate Drugs Targeting SARS-CoV-2 Main Protease

Recently, a team of Chinese scientists developed two novel compounds, 11a and 11b, that inhibit the main protease (Mpro) of SARS-CoV-2, one of which is a promising candidate for further clinical studies. This research was published online in Science. The study demonstrates that structure-based drug design is an effective strategy for designing specific antiviral lead compounds against SARS-CoV-2. Preclinical studies of compound 11a are currently underway. The team has decided to share their research data with scientists worldwide to accelerate the development of anti-SARS-CoV-2 drugs.

bioRxiv: Scientists Discover siRNA Drugs That May Inhibit SARS-CoV-2

Recently, researchers from the University of Dhaka in Bangladesh, the University of New South Wales in Australia, and BRAC University in Bangladesh decided to leverage RNA interference technology to develop small interfering RNA (siRNA) molecules targeting specific genes—namely, the nucleocapsid phosphoprotein gene and the surface glycoprotein gene. The research team collected conserved sequences from 139 SARS-CoV-2 strains worldwide and constructed 78 siRNAs capable of silencing the nucleocapsid phosphoprotein and surface glycoprotein genes. Following a rigorous screening process, eight siRNA molecules were identified as exhibiting optimal efficacy. The researchers stated that these predicted siRNAs should effectively suppress SARS-CoV-2 genes during siRNA-mediated therapy, thereby aiding in the response to SARS-CoV-2 infection.