BeiGene's PD-1 Antibody Plus Chemotherapy Meets Primary Endpoint in Phase 3 Trial for First-Line Squamous NSCLC

[January 22, 2020 / Pharmaceutical News Digest] Novel pneumonia patients eligible for special reimbursement policies; Nanyan Technology completes over RMB 100 million in Series B2 financing; China approves its first antibody-drug conjugate (ADC); GSK’s ADC drug granted FDA Priority Review designation; Johnson & Johnson’s Darzalex + VTd regimen approved in the EU... Stay tuned with Sudu She for the latest daily updates in pharmaceuticals and healthcare!

Part 1 Policy Brief

Patients with Novel Coronavirus Pneumonia Are Eligible for Special Reimbursement Policies

On the 21st, the National Healthcare Security Administration announced further strengthened guidance to healthcare security departments in Hubei and other regions, requiring the national healthcare security system to ensure treatment coverage in accordance with the “Two Guarantees”: ensuring that patients receive timely treatment without being hindered by cost concerns, and ensuring that designated medical institutions are not impeded in providing care due to regulations on total budget management for medical insurance. (National Healthcare Security Administration)

Shaanxi Provincial Drug Administration Announces 10 Batches of Substandard Drugs

On the 21st, the Shaanxi Provincial Medical Products Administration released the first drug quality bulletin of 2020, which included 9 batches of traditional Chinese medicine decoction pieces and 1 batch of proprietary Chinese medicine. (Shaanxi Provincial Medical Products Administration)

Hefei Medical Insurance Bureau Launches Comprehensive Inspection of Medical Institutions

Recently, the Hefei Municipal Healthcare Security Administration in Anhui Province issued the "Notice on Conducting a Comprehensive Investigation of Irregular Practices by Designated Medical and Pharmaceutical Institutions," announcing the decision to launch a citywide comprehensive investigation into irregular practices among designated medical institutions. (Hefei Municipal Healthcare Security Administration)

Part 2 Industry and Economics Observation

Nanyan Technology Completes Over RMB 100 Million in Series B2 Financing

Nanyan Technology Recently Announced the Completion of Over 100 Million Yuan in Series B2 Financing. It is reported that this round of financing was led by Bank of China International, with follow-on investments from shareholders including BlueRun Ventures, SIG Asia Investments, and Starr Investment Holdings. (Arterial Network)

Xinrui Announces Completion of Series A Financing

On the 22nd, Calidi Biotherapeutics announced the completion of its Series A financing round to prepare for the submission of Investigational New Drug (IND) applications for the clinical study of its investigational therapies. It is reported that the company has long been dedicated to developing oncolytic virus immunotherapies for patients with various refractory cancers. (Chuangjian Hui)

Part 3 Pharmaceutical News

BeiGene’s PD-1 Antibody Phase 3 Clinical Trial Meets Primary Endpoint

Today, BeiGene announced that its pivotal Phase 3 clinical trial evaluating tislelizumab, an anti-PD-1 antibody, in combination with two chemotherapy regimens as first-line treatment for patients with squamous non-small cell lung cancer (NSCLC) had met the primary endpoint of improving progression-free survival (PFS), as assessed by an independent review committee. (Sina Medical News)

China Approves First Antibody-Drug Conjugate

On the 21st, Roche’s Kadcyla received formal approval from the National Medical Products Administration for its marketing application in China. It is reported that this drug is the first antibody-drug conjugate (ADC) approved for marketing in China. (PharmaCube)

GSK’s ADC Drug Granted FDA Priority Review

GlaxoSmithKline Announces FDA Grants Priority Review for Belantamab Mafodotin, a BCMA-Targeting Antibody-Drug Conjugate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma (SinoPharm Source)

FDA Approves First Therapy for Thyroid Eye Disease

Horizon Therapeutics announced on the 22nd that the U.S. FDA has approved its innovative therapy, Tepezza, for the treatment of thyroid eye disease. Thyroid eye disease is a rare, progressive, severe autoimmune disorder that threatens vision. (WuXi AppTec)

Johnson & Johnson’s Darzalex + VTd Regimen Approved by the EU

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that the European Commission has approved Darzalex in combination with bortezomib, thalidomide, and dexamethasone as a first-line treatment for newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplantation. (Bioon)

New Drug for Gastric Diseases Finally Accepted for Marketing Application Resubmission

Today, Evoke Pharma announced that the U.S. FDA has accepted its resubmitted New Drug Application (NDA) for Gimoti nasal spray, with a response expected from the FDA on June 19 of this year. (WuXi AppTec)

JAZZ formulationInnovative Drug Therapy Approved by the EU

Jazz Pharmaceuticals recently announced that the European Commission has approved Sunosi for the treatment of excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea. (Bioon)