ExcelMab Secures Tens of Millions in Series A+ Funding for Bispecific Antibody Development Amid FDA's Temporary Suspension of Overseas Inspections

South Korea Reports Synthesis of Protein Capable of Recognizing Antibodies Against the Novel Coronavirus

On March 10, the Korea Disease Control and Prevention Agency (KDCA) issued a statement announcing that its affiliated National Institute of Health had recently synthesized a specific protein capable of recognizing antibodies against the novel coronavirus, thereby facilitating the development of therapeutic drugs for COVID-19. The statement indicated that this protein can be used to isolate neutralizing antibodies from patients recovering from COVID-19. Neutralizing antibodies are a class of proteins secreted by immune cells that bind to certain viruses before they enter host cells, preventing viral attachment and cellular infection, effectively “neutralizing” the virus.

“bioRxiv”: Scientists Achieve Direct Sequencing of SARS-CoV-2 RNA for the First Time

Recently, Lachlan Coin and Sebastian Duchene’s team from the Department of Microbiology and Immunology at the University of Melbourne, along with their collaborators, provided the first direct RNA sequences of the novel coronavirus, detailing the subgenomic mRNA structures of this coronavirus and describing various aspects of coronavirus evolutionary genetics revealed through shared data. The related paper was posted on the preprint server bioRxiv on March 7.

Ascletis Pharma’s Gannowei + Ritonavir Treats 11 COVID-19 Patients, All Cured and Discharged

Recently, Ascletis Pharma announced progress in a small-sample clinical study of Genvoya (danoprevir sodium tablets) combined with ritonavir for the treatment of novel coronavirus pneumonia (COVID-19): One of the treatment groups in the study, the oral Genvoya® combined with ritonavir group, planned to enroll 10 patients with novel coronavirus pneumonia, but actually enrolled 11 patients. All 11 patients who received oral Genvoya® combined with ritonavir treatment were discharged after meeting the discharge criteria outlined in the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 6)" issued by the National Health Commission.

Aismile Bio Secures Tens of Millions in RMB in Series A+ Funding for Bispecific Antibody Drug Development

Recently, Aismay Bio announced the completion of its tens-of-millions-yuan Series A+ financing round, with participation from KIP Korea Investment Partners, Guoke Industrial Investment, Mifang Capital, and Caijin Capital. The funds will be primarily used for the research and development of bispecific antibody drugs, as well as to advance the clinical trial application for its innovative bispecific antibody targeting breast cancer.

FDA to Postpone Review of Overseas Pharmaceuticals and Medical Devices Until April

On March 10, the U.S. Food and Drug Administration (FDA) announced that it would postpone nearly all inspections of overseas pharmaceuticals, medical devices, and food products until April. The FDA stated that it would employ certain “alternative tools and methods” to maintain oversight of foreign manufacturers and their products, while acknowledging that this measure could impact drug reviews.

Yiling Pharmaceutical’s Subsidiary Receives FDA Approval for Celecoxib Capsules ANDA Application

On March 11, Yiling Pharmaceutical announced that its subsidiary, Yiling Wanzhou International, had received FDA approval for its Abbreviated New Drug Application (ANDA) for Celecoxib Capsules. This approval permits the applicant to manufacture and market the product in the United States. As a new generation of non-steroidal anti-inflammatory and analgesic drugs, celecoxib achieves anti-inflammatory and analgesic effects by selectively inhibiting cyclooxygenase-2 (COX-2), thereby suppressing prostaglandin synthesis.

Janssen’s Bispecific Antibody JNJ-6372 Receives FDA Breakthrough Therapy Designation for Treating Patients with Specific Lung Cancer

On March 11, Janssen, a subsidiary of Johnson & Johnson, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its bispecific therapy, JNJ-6372, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy. Currently, there are no FDA-approved targeted therapies for lung cancer patients with EGFR exon 20 insertion mutations.

Biotech Company CytoDyn Seeks Approval to Launch Phase II Clinical Trial for Novel Monoclonal Antibody Leronlimab

On March 11, biotechnology company CytoDyn announced that it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial evaluating leronlimab for the treatment of patients with respiratory complications due to coronavirus disease 2019 (COVID-19). In the study, leronlimab is administered via subcutaneous injection at a dose of 700 mg once weekly. The study comprises three phases: screening, treatment, and follow-up. CytoDyn is currently negotiating to expedite the establishment of treatment clinics in New York and San Francisco, United States.

Gilead Announces Positive Phase Ib Trial Results for Vesatolimod, a Functional Cure Therapy for HIV

Recently, the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) is being held in Boston, USA. Gilead Sciences presented results from a Phase Ib trial of vesatolimod (GS-9620), a Toll-like receptor 7 (TLR7) agonist, as part of its HIV cure research program at the conference. The data showed that, compared with placebo, TLR7 stimulation by vesatolimod was associated with delayed time to viral rebound, enhanced immune function, and reduced levels of intact HIV DNA. Gilead also presented additional preclinical studies evaluating the potential of vesatolimod-based combination regimens to achieve viral remission after discontinuation of antiretroviral therapy (ART).

Takeda’s Oral Proteasome Inhibitor Ninlaro Extends Progression-Free Survival in Phase III Trial

Recently, Japanese pharmaceutical company Takeda announced the results of the Phase III TOURMALINE-MM2 study (NCT01850524) evaluating the oral proteasome inhibitor Ninlaro (ixazomib) for the treatment of multiple myeloma (MM). The results showed that, compared with the placebo plus lenalidomide and dexamethasone group, the median progression-free survival (PFS) in the Ninlaro plus lenalidomide and dexamethasone group was extended by 13.5 months, but this did not reach the threshold for statistical significance. In this study, the safety profile of Ninlaro was generally consistent with its existing prescribing information.

Biotech Firm Mesoblast Plans Synchronous Evaluation of Its Anti-Inflammatory Cell Therapy, remestemcel-L, in China, the U.S., Europe, and Australia

On March 11, biotechnology company Mesoblast announced plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate therapy, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by novel coronavirus (SARS-CoV-2) infection across the United States, Australia, China, and Europe. The company is actively engaging with governments, regulatory authorities, healthcare institutions, and pharmaceutical companies to facilitate the implementation of these initiatives.

Biotech Firm Atomwise Inks $1 Billion Deal with Bridge to Develop Small-Molecule Drugs Using AI

Recently, AI-driven drug design company Atomwise and BridgeBio Therapeutics jointly announced that they will initiate the development of up to 13 small-molecule drug candidates across multiple therapeutic areas, leveraging AI technology. Under the terms of the agreement, Atomwise will evaluate and launch development programs targeting Bridge’s E3 ubiquitin ligase Pellino and other targets. Atomwise will be eligible to receive total payments of up to $1 billion, as well as tiered royalties on future net sales of drugs developed through this collaboration.

The Lancet Gastroenterology & Hepatology: World’s First AI Double-Blind Randomized Controlled Trial Published

Recently, Sichuan Provincial People’s Hospital and Harvard Medical School published a double-blind randomized controlled trial (RCT) in The Lancet Gastroenterology & Hepatology on EndoScreener, Wision A.I.’s product for detecting colorectal precancerous lesions. This study marks the first global double-blind RCT in the medical AI field. The results showed that the adenoma detection rate (ADR) in the true AI system group was significantly higher than that in the sham AI system group when assisted by EndoScreener. In terms of polyp detection rate (PDR), the computer-aided detection (CAD) experimental group demonstrated a significantly higher PDR compared to the sham prompt control group. During colonoscopy procedures, the involvement of Wision A.I.’s EndoScreener significantly improved endoscopists’ detection rates.