Hengrui Addresses Subsidiary Employee Bribery Incident; AMAG Pharmaceuticals Announces Restructuring and 30% Workforce Reduction

[May 13, 2020 / Pharmaceutical News Overview]CDE Issues Important Notice on Import Drug Certification Documents; Hengrui Medicine Responds to Bribery Case Involving Subsidiary Employees: Relevant Personnel Have Left the Company; Gilead Licenses Five Generic Pharmaceutical Companies in India and Pakistan to Produce Remdesivir; Moderna’s COVID-19 Vaccine Receives FDA Fast Track Designation...Daily Fresh Pharmaceutical and Medical News: Sudu Society Keeps You Informed!

Part 1 Policy Brief

7 New Confirmed Cases Reported on May 12

From 00:00 to 24:00 on May 12, the 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps reported 7 newly confirmed cases, including 6 locally transmitted cases (all in Jilin Province) and 1 imported case (in Shanghai). (Official website of the National Health Commission)

CDE Issues Important Notice on Certificates for Imported Drugs

On the 13th, the Center for Drug Evaluation (CDE) issued a notice stating that, due to the impact of the epidemic, notarized documents from overseas could not be mailed or notarized when submitting applications for the registration of imported drugs. (CDE)

Part 2 Industrial and Economic Observation

Another Company Announces Restructuring, Laying Off 30% of Workforce!

U.S. pharmaceutical company AMAG Pharmaceuticals announced a corporate restructuring plan in its first-quarter financial report, involving the planned divestiture of its Intrarosa (prasterone) and Vyleesi (bremelanotide injection) products, as well as a 30% workforce reduction, affecting approximately 140 employees. (Sina Medical News)

Hengrui Responds to Bribery by Subsidiary Employees: Relevant Personnel Have Resigned

In response to the involvement of a doctor at a hospital in Zhejiang Province in a bribery case, Hengrui Medicine issued an announcement on the 12th to address media concerns. The company stated that the incident involved the personal misconduct of a subsidiary employee, which seriously violated the company’s management policies, but also exposed loopholes in its managerial oversight. Currently, the individuals involved have resigned, and the executive responsible for the subsidiary has been reassigned from their position. (Sina Medical News)

Gilead Licenses Five Indian and Pakistani Generic Drugmakers to Produce Remdesivir

Gilead Sciences, a U.S. pharmaceutical company, announced on its official website that it has signed non-exclusive voluntary licensing agreements with five generic drug manufacturers based in India and Pakistan to further expand the supply of remdesivir. The licenses authorize Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences, and Mylan to manufacture remdesivir and distribute it to 127 countries. (Sina Medical News)

Tasly Invests $27.5 Million to Acquire Innovative Drugs for the Treatment of Pancreatic Cancer and Melanoma

On the evening of the 11th, Tasly announced that its controlling subsidiary, Tasly Biological, recently signed the “C-REV License Agreement” with Takara Bio Inc., through which Tasly Biological has licensed in an oncolytic virus product for the treatment of pancreatic cancer and melanoma. (Sina Pharmaceutical News)

Part 3 Pharmaceutical News

CanSino Biologics Collaborates with the National Research Council Canada to Advance Vaccine Development and Conduct Clinical Trials

CanSino Biologics announced that the company has partnered with the National Research Council of Canada to jointly advance clinical trials in Canada of its recombinant vaccine for public health emergencies (adenovirus vector). The clinical study will commence with Phase I/II trials, aiming to proceed to Phase III trials to demonstrate the vaccine’s clinical protective efficacy as rapidly as possible. (Sina Medical News)

Moderna’s COVID-19 Vaccine Granted FDA Fast Track Designation

Moderna Announces FDA Grants Fast Track Designation to Its COVID-19 Vaccine Candidate mRNA-1273The Fast Track designation is designed to facilitate the development of innovative therapies or vaccines for serious conditions and unmet medical needs, and to expedite their review process. Programs granted Fast Track status can engage in earlier and more frequent communications with the FDA and may submit marketing applications on a rolling basis. This marks the fourth Moderna development program to receive Fast Track designation. (WuXi AppTec)

Sanofi’s CD38 Antibody Combination Therapy for Multiple Myeloma Meets Phase 3 Clinical Endpoints

Sanofi announced that its developed CD38 antibody Sarclisa (isatuximab-irfc), in combination with dexamethasone and carfilzomib, met the primary endpoint in the interim analysis of the Phase 3 IKEMA clinical trial in patients with multiple myeloma (MM). Compared to treatment with dexamethasone and carfilzomib alone, the addition of isatuximab significantly reduced the risk of disease progression or death. The positive data from this trial will support the submission of regulatory applications for isatuximab. (WuXi AppTec)

Umbilical Cord Blood Stem Cell Therapy Omidubicel Meets Phase 3 Clinical Trial Endpoints

Today, Gamida Cell, a cell therapy company dedicated to finding cures for blood cancers and severe blood disorders, announced that its investigational cell therapy omidubicel achieved positive top-line results in a Phase 3 clinical study involving patients with high-risk hematologic malignancies who required bone marrow transplantation. (WuXi AppTec)

Roche’s Integrin Antibody UC Phase III Data Release Imminent

Currently, Roche is developing a new drug, etrolizumab, a dual-acting anti-integrin antibody. Data from five Phase III clinical trials in ulcerative colitis (UC) are expected to be released soon, including two placebo-controlled studies, two head-to-head trials against adalimumab (Humira), and one against Johnson & Johnson’s Remicade. The first key Phase III clinical data are scheduled to be announced in mid-year this year. (Sina Pharmaceutical News)

HEC Pharm Launches Another Class 1 New Drug! Targeting Lymphoma

On the 12th, the clinical trial application for HEC89736PTSA·0.5H2O tablets, a Class 1 new drug from East Sunshine Pharmaceutical, was accepted by the Center for Drug Evaluation (CDE), with acceptance numbers CXHL2000195, CXHL2000196, and CXHL2000197. According to Menet, HEC89736PTSA·0.5H2O is a PI3Kδ inhibitor, with proposed clinical indications for chronic lymphocytic leukemia/small lymphocytic lymphoma. Currently, there are no PI3Kδ inhibitors approved for marketing in China. (Menet)

1.4 Billion Anti-tumor Injection: This Sichuan Pharmaceutical Company Takes the Lead

The CDE website indicates that GenScript Biopharma’s bortezomib for injection is proposed for inclusion in the priority review program, with the rationale being “manufactured on the same production line, already marketed in the United States in 2020, and applying for domestic market approval.” Data from Menet show that sales of bortezomib at public medical institutions in China reached RMB 1.442 billion in 2018. (CDE)

Invivoscribe Submits Application for LeukoStrat® CDx FLT3 Mutation Assay

Invivoscribe announced that it had submitted the application for LeukoStrat® CDx FLT3 Mutation Assay to Chinese regulatory authorities in April, in support of Astellas Pharma’s new drug application for XOSPATA® (gilteritinib), a treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations. Invivoscribe also announced the expansion of its wholly-owned subsidiary, Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd., to include laboratory testing services, providing support for clinical trials and pharmaceutical partners. (PR Newswire)