Haibowei Pharmaceuticals Completes Tens of Millions RMB Angel+ Round, Bringing Total Equity Financing to Nearly 100 Million RMB

Haibowei Pharma Completes Tens of Millions in Angel+ Round, Cumulative Equity Financing Reaches Nearly 100 Million Yuan

On April 12, VCBeat learned that Haibowei Pharma, an emerging company in China’s pharmaceutical R&D and manufacturing sector, recently announced the completion of its tens-of-millions-of-yuan Angel+ financing round. To date, Haibowei Pharma has nine internationally leading R&D pipelines covering areas such as oncology, central nervous system disorders, autoimmune diseases, analgesia, and depression. One of its investigational projects has basically identified a clinical candidate compound with the potential to become best-in-class, and is expected to file for clinical trials in the near future. Another investigational project has identified several candidate compounds anticipated to offer lower clinical doses and improved safety profiles; it is expected to finalize the selection of a clinical candidate drug soon and rapidly advance subsequent R&D efforts.

GW Pharma’s Cannabinoid Antiepileptic Drug Epidiolex Removed from Controlled Substances List in the United States

Recently, UK pharmaceutical company GW Pharma announced that it had received a notification letter from the U.S. Drug Enforcement Administration (DEA), confirming that the oral liquid formulation of Epidiolex (cannabidiol, CBD), a cannabinoid-based antiepileptic drug, is no longer subject to the Controlled Substances Act, with this change taking effect immediately. Epidiolex is the first high-purity, plant-derived cannabidiol (CBD) prescription pharmaceutical formulation and also the first novel antiepileptic drug (AED). It was approved by the U.S. FDA in June 2018 as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients aged two years and older.

Remdesivir Compassionate-Use Trial Data Released: 68% of Critically Ill Patients Show Symptom Relief

On April 10, The New England Journal of Medicine published a study report on the use of remdesivir to treat patients with severe COVID-19 under compassionate-use conditions. The results showed that 68% of patients experienced symptom improvement after treatment, while 13% died after completing the course of therapy. However, Gilead Sciences also emphasized that data from compassionate-use programs have limitations. Previously, the China National Intellectual Property Administration stated that clinical trials of the drug had been initiated at multiple hospitals in Wuhan, and the trial results would not be released until April 27.

Huiyu Pharmaceutical’s Oxaliplatin Injection Proposed for Priority Review

On April 13, according to the official website of the Center for Drug Evaluation (CDE), Sichuan Huiyu Pharmaceutical’s Oxaliplatin Injection was proposed for inclusion in the priority review program. The rationale cited was that the product is manufactured on the same production line as its counterpart already marketed in European Union countries since 2020, and the company is applying for domestic market approval. Data from Menet shows that sales of oxaliplatin at public medical institutions in China reached RMB 3.144 billion in 2018. Currently, no enterprise has passed the consistency evaluation for oxaliplatin injections. Huiyu Pharmaceutical submitted its application under Category 3 of new chemical drugs; if approved, it will be deemed to have passed the consistency evaluation.

Hengrui Medicine Initiates Phase III Clinical Trial of Neoadjuvant PD-L1 Inhibitor Combined with Chemotherapy for Non-Small Cell Lung Cancer

On April 10, Hengrui Medicine registered and initiated a randomized, double-blind, multicenter Phase IB/III clinical study of SHR-1316 or placebo in combination with chemotherapy as perioperative treatment for resectable non-small cell lung cancer (NSCLC). This randomized, double-blind, parallel-group Phase III clinical trial is led by Professor Wu Yilong from Guangdong Provincial People’s Hospital as the principal investigator, and plans to enroll 486 patients with resectable NSCLC. The study aims to compare the major pathological response rate of SHR-1316 or placebo combined with chemotherapy as neoadjuvant therapy for resectable NSCLC, and to compare the event-free survival of SHR-1316 or placebo combined with chemotherapy as perioperative therapy for resectable NSCLC.

Biotech Company BioMarin Plans to File for Marketing Approval of C-Type Natriuretic Peptide Analog Vosoritide in Q3

On April 13, 2020, global biotechnology company BioMarin announced that, following recent meetings with regulatory authorities in the United States and Europe, it plans to submit marketing applications for vosoritide (BMN111) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the third quarter of 2020. Vosoritide is an investigational, once-daily injectable C-type natriuretic peptide (CNP) analog developed for the treatment of achondroplasia. If approved, vosoritide would become the first therapy for achondroplasia in both the United States and the European Union.

Seattle Genetics Updates Urothelial Cancer Multi-Cohort Phase Ib/II EV-103 Trial, Reporting 73.3% Overall Response Rate in First-Line Treatment

Seattle Genetics Provides Update on the EV-103 Trial (Also Known as KEYNOTE-869, NCT03288545), a Multi-Cohort Phase Ib/II Study in Urothelial Carcinoma (UC)Recently, Seattle Genetics provided an update on the EV-103 trial (also known as KEYNOTE-869, NCT03288545), a multi-cohort Phase Ib/II study in urothelial carcinoma (UC). The trial is evaluating the combination of the antibody-drug conjugate Padcev (enfortumab vedotin) and Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy and are not candidates for surgical resection. The results demonstrated that the first-line combination of Padcev and Keytruda achieved an objective response rate (ORR) of 73.3% in UC.

Antengene’s PAK4/NAMPT Dual-Target Oral Inhibitor ATG-019 Completes First Patient Dosing

Recently, Antengene announced that the first patient has been dosed in its Phase I open-label clinical trial of ATG-019, an oral dual PAK4/NAMPT inhibitor, in Taiwan, China. The trial aims to evaluate the safety and tolerability of ATG-019 as monotherapy and in combination with niacin ER (vitamin B3/nicotinic acid) for the treatment of advanced solid tumors or non-Hodgkin lymphoma. ATG-019 is the world’s first and only oral dual inhibitor targeting p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT).

Salubris’ Teriparatide Injection IND Application Accepted

On April 13, Salubris Pharmaceuticals announced that the company and its subsidiaries, Salubris (Suzhou) Pharmaceutical Co., Ltd. and Salubris (Chengdu) Biotechnology Co., Ltd., recently received Notices of Acceptance issued by the National Medical Products Administration (NMPA), indicating that the clinical trial application for “Teriparatide Injection” has been accepted. The proposed indication for Teriparatide Injection is the treatment of osteoporosis in postmenopausal women at high risk of fractures. The product is intended for once-daily subcutaneous injection without the need for reconstitution prior to administration, thereby offering greater convenience for patients.

Samsung Biologics and Biotechnology Reach $362 Million Collaboration to Expand Production of COVID-19 Candidate Antibodies

Recently, Vir Biotechnology and Samsung Biologics signed a $362 million collaboration agreement to expand the manufacturing program for Vir’s monoclonal antibody, which holds promise as a potential therapy for COVID-19. As part of the agreement, Samsung Biologics is expected to conduct its first engineering batch production in early October this year, with the possibility of commencing commercial-scale manufacturing at its facilities in 2021. Both parties aim to finalize the definitive terms of the transaction by July 31.

Lilly to Collaborate with U.S. National Institute of Allergy and Infectious Diseases on Clinical Testing of Potential COVID-19 Therapies

On April 10, Eli Lilly and Company (Lilly) announced that it had reached an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to provide the JAK1/2 inhibitor baricitinib as part of NIAID’s adaptive clinical trial of therapies for COVID-19. The study, conducted by NIAID, will launch in the United States this month and is planned to expand to Europe and Asia, evaluating the efficacy of multiple therapies in treating patients with COVID-19. Results from this clinical trial are expected within the next two months. Baricitinib is an approved oral JAK1/2 inhibitor indicated for the treatment of moderate to severe rheumatoid arthritis.

The COVID-19 vaccine developed by Sinopharm will enter clinical trials; it is an inactivated vaccine.

On April 13, the Phase I/II clinical trial of the inactivated novel coronavirus (COVID-19) vaccine (Vero cell) developed by Wuhan Institute of Biological Products Co., Ltd., a subsidiary of China National Biotec Group (CNBG) under Sinopharm, was listed in the Chinese Clinical Trial Registry with a pre-registration status of “under review.” According to public information, this is the second novel coronavirus vaccine in China to enter clinical trials, following the vaccine developed by the team led by Chen Wei, an academician of the Chinese Academy of Engineering and researcher at the Academy of Military Medical Sciences of the Academy of Military Sciences.

Pharmaceutical Company CalciMedica Announces Phase 2 Trial of CRAC Inhibitor for Treating Severe COVID-19 Patients

Recently, U.S. pharmaceutical company CalciMedica announced that it had received a letter from the U.S. Food and Drug Administration (FDA) requesting the company to study the efficacy of CM4620-IE in treating severe COVID-19 patients at risk of developing acute respiratory distress syndrome (ARDS). CM4620 is a calcium release-activated calcium (CRAC) channel inhibitor. In 2017, the FDA granted fast track designation to CM4620 for the treatment of acute pancreatitis.

Jinghua Pharmaceutical’s Non-Independent Director Du Yongchao Resigns for Work-Related Reasons

On April 11, Jinghua Pharmaceutical announced that its Board of Directors received a written resignation letter from Du Yongchao, a non-independent director, on April 10, 2020. Following his resignation, Mr. Du will no longer hold any position within the company. It is reported that Mr. Du has applied to resign from his positions as a Company Director and as a member of the Remuneration and Appraisal Committee due to job reassignment for work-related reasons.

Northeast Pharmaceutical Group Deputy General Manager Zheng Changsheng Resigns Due to Personal Reasons

On April 11, Northeast Pharmaceutical Group Co., Ltd. announced that its Board of Directors received a written resignation letter from Zheng Changsheng, the Company’s Deputy General Manager, on April 10, 2020. In accordance with relevant regulations, Mr. Zheng’s resignation became effective upon delivery to the Board of Directors. It is reported that Mr. Zheng resigned from his position as Deputy General Manager due to personal reasons. Following his resignation, Mr. Zheng will not hold any position within the Company. As of the date of this announcement, Mr. Zheng does not hold any shares in the Company.

Global Rankings of Pharmaceutical Companies by Invention and Innovation Released: Roche Tops the List for the First Time

Recently, IDEA Pharma released the 10th Edition of its Pharmaceutical Company Innovation Ranking. Roche topped the overall innovation ranking for the first time, while AstraZeneca secured the top spot in the R&D Pipeline Ranking. After dropping from 1st place in 2018 to 12th in 2019, AstraZeneca returned to the top ten this year, ranking sixth. Roche surged from 8th place in 2019 to first. IDEA Pharma attributed this significant rise to the accumulation of multiple clinical data sets for the PD-L1 inhibitor atezolizumab (brand name Tecentriq), as well as two new FDA approvals.

medRxiv: High-dose chloroquine treatment for COVID-19 patients poses safety risks, with a trend toward higher mortality

On April 11, a research team from Brazil released preliminary safety results from CloroCovid-19, a parallel, double-blind, randomized Phase IIb clinical trial (NCT04323527), on the preprint platform medRxiv. The researchers concluded that the initial findings indicate safety concerns with the high-dose chloroquine regimen (12 g) and strongly recommended against its use for treating COVID-19 anywhere.

《bioRxiv》: Influenza Prophylactic Drug Amantadine May Be Effective in Treating COVID-19

Recently, researchers from Vanda Pharmaceuticals in Washington, D.C., conducted high-throughput drug screening and gene expression analysis to identify compounds that may downregulate CTSL/CTSB expression. The study revealed one of the most significant findings: amantadine can downregulate CTSL gene expression. Based on this, the researchers posit that amantadine may reduce viral load in SARS-CoV-2-positive patients, suggesting its potential as an effective therapeutic agent to inhibit viral replication and transmissibility, thereby potentially leading to improved clinical outcomes.

《biorxiv》: Two Components in HIV Drugs Can Effectively Inhibit SARS-CoV-2 Polymerase

Recently, researchers from Columbia University and the University of Wisconsin–Madison reported in a study published on bioRxiv that the triphosphate forms of tenofovir and emtricitabine—the two active ingredients in DESCOVY and TRUVADA—can act as terminators of the SARS-CoV-2 RdRp-catalyzed reaction. Tenofovir and emtricitabine are the two components of DESCOVY and TRUVADA, both of which are FDA-approved pre-exposure prophylaxis (PrEP) medications for the prevention of HIV infection.