K药 Combination Therapy Receives FDA Priority Review; Betta Pharmaceuticals Announces Ensartinib Pricing

[December 18, 2020 / Pharmaceutical News Digest] Keytruda combination therapy granted FDA Priority Review; FDA approves first-ever therapy for lupus nephritis; three Class 1 new drugs proposed for Breakthrough Therapy designation; pricing for Betta Pharmaceuticals’ ensartinib revealed; reports suggest Viatris plans further layoffs... Stay tuned with Sudu She for the latest daily updates in pharmaceuticals and healthcare!

Part 1 Policy Brief

National Healthcare Security Administration Advances the Implementation of National Centralized Procurement and Utilization of Coronary Stents

On December 17, the National Healthcare Security Administration (NHSA) issued the "Opinions on Supporting Measures for the Centralized Volume-Based Procurement and Use of Coronary Stents Organized by the State." The Opinions state that healthcare security departments in all pooling regions shall establish an advance payment mechanism based on the overall budget management of healthcare security funds. After medical institutions sign procurement agreements with the selected enterprises, the healthcare security funds shall prepay no less than 30% of the annually agreed procurement amount to the medical institutions. It is also emphasized that the selected coronary stent products from the centralized procurement shall be listed on provincial pharmaceutical centralized procurement platforms at the selected prices, medical institutions shall procure them at the selected prices, and patients shall use them at the selected prices. (National Healthcare Security Administration)

Shandong Launches Volume-Based Procurement for Five Categories of Medical Consumables

On December 16, the Shandong Provincial Public Resources Trading Center released the "Shandong Province Centralized Volume-Based Procurement Document for High-Value Medical Consumables (Draft for Comments)," indicating that volume-based procurement will be conducted for five categories of consumables: rapid-exchange dilation balloons for coronary intervention, primary total hip arthroplasty prostheses, absorbable dural (spinal) membrane patches, disposable trocar cannulas, and dual-chamber cardiac pacemakers. The document requires the aggregation of the projected procurement volumes submitted by medical institutions for the following year, and determines the contracted procurement volume for the selected enterprises in each group as 70% of the corresponding procurement demand for that group. (Shandong Provincial Public Resources Trading Center)

Part 2 Industry and Economics Observation

Viatris Reportedly to Cut Jobs Again

Recently, media reports have revealed Viatris’s new layoff plan. According to available information, the employees slated for layoffs are from the pain management division. It is reported that 20% of the sales representatives in the anti-infective product line in a certain region will be laid off next week. Previously, internal adjustments were made in certain regions within the CV+ Pain division. Currently, adjustments and competitive bidding processes in some regions have just begun. (Sina Medical News)

Novartis Acquires Cadent for $770 Million

Novartis Announces Acquisition of Cadent for $210 Million Plus Up to $560 Million in Potential Milestone PaymentsNovartis recently announced that it is acquiring Cadent for $210 million, with an additional potential $560 million in milestone payments. Novartis will acquire all outstanding shares of Cadent, and the transaction is expected to close in the first quarter of next year. Through this acquisition, Novartis will gain Cadent’s complete neuroscience portfolio, including its NMDAr program. (Sina Medical News)

Neurogene Completes $115 Million Series B Financing

Neurogene Announces Completion of $115 Million Series B Financing Led by EcoR1 CapitalNeurogene is dedicated to the research and development of innovative gene therapies for rare neurological disorders. The company utilizes adeno-associated virus (AAV) vectors to deliver functional genes to patients with genetic dysfunction. (Chuangjianhui)

Jishi Capital Acquires Innovative Surgical Robotics Company

On December 16, Jishi Capital announced the completion of its controlling acquisition of Endoways, a company specializing in fully disposable vascular interventional surgical robots. Following this acquisition, Jishi Capital will collaborate with its strategic partner, Deno Medical, to continuously advance the development and market launch of Endoways’ core products, particularly focusing on clinical trials and regulatory approval for market entry in China. (Chuangjianhui)

Ensartinib Pricing by Beta Pharma Announced

Today, in response to investor inquiries, Betta Pharmaceuticals stated that the terminal selling price of ensartinib hydrochloride capsules is RMB 1,358 per bottle (specification: 25 mg × 7 capsules/bottle) and RMB 7,644 per bottle (specification: 100 mg × 14 capsules/bottle). (Insight Database)

Part 3 Pharmaceutical News

Keytruda Combination Therapy Granted FDA Priority Review

Today, Merck & Co. announced that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for its blockbuster PD-1 inhibitor Keytruda, in combination with chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal cancer and gastroesophageal junction (GEJ) cancer. The FDA has also granted Priority Review designation to this application. (WuXi AppTec)

FDA Approves First Therapy for Lupus Nephritis

Today, GlaxoSmithKline announced that the U.S. FDA has approved an expanded indication for Benlysta for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. This is the first FDA-approved therapy specifically for lupus nephritis. (WuXi AppTec)

Boehringer Ingelheim's Nintedanib Approved for New Indication in China

Today, the NMPA issued a notice announcing the approval of Boehringer Ingelheim’s tyrosine kinase inhibitor (TKI) nintedanib (Ofev) for a new indication submitted in China. The newly approved indication is for the treatment of progressive fibrosing interstitial lung disease. (Yiyao Guanlan)

FDA Advisory Committee Near-Unanimously Backs Moderna’s COVID-19 Vaccine

Today, at the VRBPAC meeting convened by the U.S. FDA, experts discussed the Emergency Use Authorization (EUA) application for mRNA-1273, the COVID-19 vaccine developed by Moderna. Ultimately, the attending experts voted 20 in favor and 1 abstention, supporting that, based on existing scientific evidence, the benefits of Moderna’s COVID-19 vaccine outweigh its risks when used in individuals aged 18 years and older. (WuXi AppTec)

Amgen’s Rituximab Biosimilar RIABNI Approved by FDA for Market Launch

On December 17, Amgen announced that the U.S. FDA had approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan, for marketing in the United States. It is indicated for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. RIABNI is scheduled to launch in January 2021. (Sina Medical News)

EU CHMP Recommends Approval of Sanofi’s Plavix in Combination with Aspirin for the Treatment of Specific Types of Stroke

Sanofi Announces Positive CHMP Opinion Recommending Approval of New Indication for Plavix (Clopidogrel) in Adult Patients with High-Risk Transient Ischemic Attack or Minor Ischemic StrokeRecently, Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of a new indication for Plavix (clopidogrel): for the treatment of adult patients with high-risk transient ischemic attack (TIA) or minor ischemic stroke. This new indication involves the combination of Plavix with aspirin initiated within 24 hours of symptom onset and continued for 21 days, followed by long-term monotherapy with an antiplatelet agent. (Bioon)

Keytruda Combined with LENVIMA Achieves Dual Primary Endpoints in Phase III Clinical Trial for Advanced Endometrial Cancer

On December 16, Merck & Co. and Eisai Co., Ltd. jointly announced that their collaborative Phase III clinical trial, KEYNOTE-775/Study 309, met its dual primary endpoints of overall survival and progression-free survival, as well as the secondary efficacy endpoint of objective response rate, in patients with advanced endometrial cancer who had previously received at least one platinum-based therapy. (Sina Medical News)

Gilead’s Tecartus Receives Conditional European Approval for Mantle Cell Lymphoma

Gilead’s Subsidiary Kite Pharma Announces Conditional Marketing Authorization Granted by European Commission for Tecartus (formerly KTE-X19)Recently, Kite Pharma, a subsidiary of Gilead Sciences, announced that the European Commission has granted conditional marketing authorization for Tecartus (formerly known as KTE-X19). Tecartus is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy indicated for adult patients with relapsed or refractory mantle cell lymphoma who have undergone two or more prior lines of systemic therapy. (Sina Medical News)

Three Class 1 New Drugs Proposed for Inclusion in the Breakthrough Therapy Designation Program

Today, the CDE released its latest announcement, proposing to include three new drugs in the Breakthrough Therapy Designation program: Blueprint Medicines/Jake Biopharmaceuticals’ RET inhibitor BLU-667 capsules, intended for systemic treatment of patients with advanced or metastatic medullary thyroid cancer (MTC) harboring RET mutations; Chipscreen Biosciences’ multi-target, multi-pathway selective kinase inhibitor chioronib capsules, intended as monotherapy for small cell lung cancer (SCLC) that has progressed or relapsed after two lines of systemic chemotherapy; and Dizal Pharmaceutical’s EGFR inhibitor DZD9008 tablets, intended for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations in patients who have received at least one prior line of systemic chemotherapy. (Yiyao Guanlan)

Qilu Pharmaceutical’s Palbociclib Approved for Market Launch

Today, the NMPA issued an approval document for Qilu Pharmaceutical’s Class 4 generic drug, palbociclib capsules, marking the first domestic generic approval for this product. Its indicated use is in combination with aromatase inhibitors as first-line treatment for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. (Insight Database)

Yangtze River Pharmaceutical Group’s Iodixanol Injection Receives Approval for Two Supplemental Applications and Passes Consistency Evaluation

Today, the NMPA website showed that two supplemental applications for Yangtze River Pharmaceutical Group's iodixanol injection have been approved and passed evaluation. Data from Menet shows that in recent years, sales of iodixanol injections at public medical institutions in China have grown rapidly, exceeding 3 billion yuan in 2019; however, they declined by 4.18% year-on-year in the first half of this year. (Menet)

Hua Medicine Completes Phase 3 Registration Study for Dorzagliatin

Hua Medicine Announces Core Results from the 28-Week Safety Assessment Phase of DAWN, the Second Phase 3 Registrational Clinical Study of DorzagliatinToday, Hua Medicine announced the core results from the 28-week safety assessment phase of DAWN, the second Phase 3 registrational clinical study of dorzagliatin. The study results demonstrated that dorzagliatin exhibited a favorable safety and tolerability profile, with an incidence of hypoglycemia (blood glucose <3 mmol/L) of less than 1% during the 52-week treatment period. Meanwhile, patients showed sustained reductions in insulin resistance indicators. (Medical Observer)

Antengene’s Phase 3 Clinical Trial of SVd Combination Therapy for rrMM Approved by NMPA

Today, Antengene announced that the NMPA has approved its clinical trial application for the oral selective nuclear export inhibitor ATG-010 (selinexor) in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma in China. ATG-010 is the first-in-class and only oral selective nuclear export inhibitor. (PR Newswire)

NMPA Accepts Marketing Registration Application for HLX01's New Indication

On December 17, Henlius announced that the National Medical Products Administration (NMPA) had formally accepted its marketing authorization application for HLX01 (rituximab injection) for a new indication: rheumatoid arthritis. (Medical Representative)

Tagrisso's Third-Generation ALK Inhibitor Approved for Clinical Trials

On December 17, according to the public notice issued by the Center for Drug Evaluation (CDE), Tagirui Biopharma’s TGRX-326 tablets, submitted as a Class 1 chemical drug, received two implied approvals for clinical trials. The intended indications are advanced non-small cell lung cancer (NSCLC) that is ALK-positive and/or ROS1-positive. According to publicly available information, TGRX-326 is a third-generation highly potent ALK inhibitor targeting the EML4-ALK fusion gene. (Yiyao Guanlan)

Henlius’ Rituximab Biosimilar New Indication Marketing Application Accepted

On December 17, Henlius announced that the NMPA had officially accepted its marketing authorization application for HLX01, a rituximab biosimilar, for the new indication of rheumatoid arthritis. (Medical Representative)

Sinopharm's Butorphanol Tartrate Injection Marketing Application Accepted

On December 16, the CDE website showed that Sinopharm Guorui Pharmaceutical’s Class 3 generic marketing application for butorphanol tartrate injection was accepted. Data from Menet indicates that in the past two years, the growth rate of butorphanol injections at the terminal end of Chinese public medical institutions exceeded 30%, with sales surpassing 1.5 billion yuan; however, in the first half of this year, there was a year-on-year decline of 2.16%, and Hengrui Medicine is currently the only manufacturer. (Menet)

Nature: POLRMT allosteric inhibitors effectively combat tumors without harming healthy cells

On December 16, a latest study published in Nature reported that researchers from the Karolinska Institute in Sweden developed a novel inhibitor targeting mitochondrial DNA, offering an alternative to previous “mutually destructive” mitochondrial inhibition strategies. This inhibitor blocks cancer cell proliferation and reduces tumor growth in mice, without causing significant effects on healthy cells. (PharmaCube)