BeiGene's PD-1 Inhibitor Tislelizumab Granted Third Indication in China for First-Line Squamous NSCLC

[January 13, 2021 / Pharmaceutical News Overview]Sinopharm Group Chairman and Sinopharm Co., Ltd. General Manager Resign on Same Day; BeiGene’s PD-1 Inhibitor Gains Approval for Third Indication; Merck’s 15-Valent Pneumococcal Vaccine Receives FDA Priority Review……Daily Fresh Pharmaceutical and Medical News: Sudu She Keeps You Informed!

Part 1 Policy Brief

Heilongjiang Reports 16 New Confirmed Cases and 12 New Asymptomatic Infections

From 0:00 to 24:00 on January 12, 2021, Heilongjiang Province reported 16 newly confirmed cases of COVID-19 (13 asymptomatic infections in Wangkui County were reclassified as confirmed cases, and 3 cases in Xiangfang District). One confirmed case was discharged after recovery (Aihui District, Heihe City). Twelve new asymptomatic infections were reported (2 in Wangkui County, 2 in Beilin District of Suihua, 7 in Ang'angxi District, and 1 in Daqingshan County), all of whom were close contacts or secondary close contacts of the confirmed cases and asymptomatic infections in Huiqi Village, Huiqi Town, Wangkui County. (CCTV News)

Hebei Reports 90 New Locally Transmitted Confirmed Cases

From 0:00 to 24:00 on January 12, 2021, Hebei Province reported 90 new locally transmitted confirmed cases of novel coronavirus pneumonia, including 84 cases in Shijiazhuang City (27 of which were asymptomatic infections that progressed to confirmed cases) and 6 cases in Xingtai City. No new deaths or suspected cases were reported. (CCTV News)

Shijiazhuang Reports 26 New Local Confirmed Cases and 2 New Local Asymptomatic Cases

On the afternoon of January 13, Shijiazhuang City held a press conference on the prevention and control of the novel coronavirus pneumonia epidemic, providing updates on relevant epidemic control measures. Meng Xianghong, Deputy Mayor of Shijiazhuang, announced at the conference that from 0:00 to 12:00 on January 13, Shijiazhuang reported 26 newly confirmed cases and 2 asymptomatic infections. (CCTV News)

Shanghai: Suspension of Procurement for One Year on Key Products from Weiming, Libang, and Jinshan

On January 12, the Shanghai Municipal Pharmaceutical Centralized Bidding and Procurement Management Office issued a notice on suspending the online procurement eligibility of certain self-pay drugs. The notice stated that, in accordance with the "Notice on Further Strengthening the Procurement and Use Management of Self-Pay Drugs in Designated Medical Institutions Covered by Medical Insurance in This Municipality" and the "Notice on Further Improving the Online Procurement Work of Self-Pay Drugs in This Municipality," the online procurement eligibility of certain drugs not complying with the relevant regulations for self-pay drug listing would be suspended for one year, effective from January 15, 2021. The products involved mainly include Alprostadil Injection from Xi'an Libang Pharmaceutical, Mouse Nerve Growth Factor for Injection from Unimed Biopharmaceuticals, and Cinepazide Maleate Injection from Fujian Jinshan Bio-Pharmaceutical. (Shanghai Sunshine Pharmaceutical Procurement Network)

Jilin Province Suspends Online Listing Eligibility for Two Deregistered Products

On January 13, the Jilin Provincial Public Resources Trading Center issued a notice on suspending the drug trading qualifications of Chifeng Weikang Biochemical Pharmaceutical Co., Ltd. and Nagqu Prefecture Pioneer Pharmaceutical Co., Ltd. The notice stated that, in accordance with the National Medical Products Administration’s Announcement on the Cancellation of Drug Registration Certificates for 115 Drugs Including Paracetamol Tablets, the registration certificates for Wei U Belladonna and Aluminum Capsules produced by Chifeng Weikang Biochemical Pharmaceutical Co., Ltd. and for Nifuratel Tablets bid on by Nagqu Prefecture Pioneer Pharmaceutical Co., Ltd. had been cancelled. After review and deliberation, it was decided to suspend the online trading qualifications for these two products. (Jilin Provincial Public Resources Trading Center)

Notice on the Adjustment of Reference Prices for Online Procurement of Drugs by Three Enterprises, Including Sichuan Huiyu Pharmaceutical

On January 12, the Shanxi Provincial Drug and Medical Device Centralized Bidding and Procurement Center issued a notice on adjusting the reference procurement prices for listed drugs from three enterprises, including Sichuan Huiyu Pharmaceutical. According to the notice, upon enterprise application, the reference procurement price for Azacitidine for Injection (100 mg) manufactured by Sichuan Huiyu Pharmaceutical has been adjusted to RMB 260 per vial; the reference procurement prices for Docetaxel Injection manufactured by Chengdu Huiyu Biotechnology have been adjusted to RMB 808 per ampoule for the 1 mL:20 mg specification and to RMB 2,335.12 per ampoule for the 4 mL:80 mg specification; and the reference procurement price for Capecitabine Tablets (0.5 g × 12 tablets/box) manufactured by Shanghai Roche Pharmaceuticals has been adjusted to RMB 264.25 per box. (Shanxi Provincial Drug and Medical Device Centralized Bidding and Procurement Center)

"Measures for the Administration of Post-Marketing Changes to Drugs (Trial)" Released

On January 13, the National Medical Products Administration (NMPA) issued the Administrative Measures for Post-Marketing Changes to Drugs (Trial), to regulate post-marketing changes conducted by drug marketing authorization holders. This is China’s first normative document specifically addressing post-marketing changes to drugs. The Measures align with the legislative intent and relevant provisions of the Drug Administration Law, the Vaccine Administration Law, the Administrative Measures for Drug Registration, and the Administrative Measures for Drug Production Supervision, ensuring institutional coherence. They clarify the regulatory requirements for post-marketing changes to drugs, stipulate that marketing authorization holders bear primary responsibility for such changes, and establish new pathways for managing post-marketing changes to drugs. (National Medical Products Administration)

Part 2 Industry and Economic Observation

Chairman of Sinopharm Group and General Manager of Sinopharm Shares Resign on the Same Day

On the evening of January 12, Sinopharm Group Co., Ltd. announced on the Hong Kong Stock Exchange that Li Zhiming, Chairman of the Board, had resigned for personal reasons. The announcement stated that Mr. Li confirmed there were “no disagreements” with the Board of Directors, and that there were no matters related to his resignation requiring the attention of the company’s shareholders and creditors. On the same day, Sinopharm Group issued another announcement regarding personnel changes at its controlled subsidiary, Sinopharm Group China National Pharmaceutical Co., Ltd. (“Sinopharm Shares”). Li Hui, a Director and General Manager of Sinopharm Shares, ceased to serve as a Director of the Seventh Board of Directors, a member of the Strategy Committee, a member of the Audit Committee, and General Manager of Sinopharm Shares, due to personal reasons. (Sinopharm Group Announcement)

Gilead and Vir Partner to Develop Curative Therapies for Hepatitis B

Recently, Gilead Sciences and the emerging biotechnology company Vir announced a collaboration to jointly seek curative treatments for hepatitis B liver disease. The financial terms of the partnership were not disclosed. On December 10 last year, Gilead announced the acquisition of the German biotech firm MYR GmbH for approximately $1.4 billion, thereby obtaining Hepcludex, a novel hepatitis drug for the treatment of chronic hepatitis D virus infection. This new collaboration between Gilead and Vir on hepatitis B aims to improve upon currently marketed hepatitis B therapies. (Sina Pharmaceutical News)

Sanofi and Biond Sign $1.1 Billion Collaboration to Co-Develop ILT2 Antibody Inhibitor

On January 12, Biond announced that it had entered into a global exclusive licensing agreement with Sanofi to develop and commercialize BND-22. BND-22 is a humanized IgG4 antibody antagonist targeting the immunoglobulin-like transcript 2 (ILT2) receptor for the treatment of solid tumors. ILT2 is a member of the ILT family of immunoregulatory receptors and functions as an inhibitory receptor expressed on innate and adaptive immune cells. It binds to MHC class I molecules, including HLA-G, an immunosuppressive protein expressed by various tumor types. (Sina Medical News)

Boehringer Ingelheim and Enara Bio Enter into Strategic Collaboration and Licensing Agreement

On January 13, Boehringer Ingelheim and Enara Bio announced a strategic collaboration and licensing agreement to research and develop novel targeted cancer immunotherapies by leveraging Enara Bio’s Dark Antigen™ discovery platform. Enara Bio’s proprietary Dark Antigen platform technology will be used to explore and validate novel dark antigens for application in up to three types of lung cancer and gastrointestinal cancers. The identification of shared antigens will facilitate the development of vaccines that can be rapidly deployed to benefit a broader population of cancer patients. (PR Newswire)

Part 3 Pharmaceutical News and Medical Updates

Roche’s “T+A” Regimen Significantly Improves Overall Survival in Patients with Liver Cancer

On January 12, Roche announced that it would formally present the latest overall survival results from the Phase 3 IMbrave150 clinical trial at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium held later that month. The trial evaluated the combination of the PD-L1 inhibitor Tecentriq and the anti-VEGF therapy Avastin as a first-line treatment for patients with advanced hepatocellular carcinoma. Data showed that the median overall survival for patients treated with the “T+A” regimen was 19.2 months, with the Chinese subgroup achieving a median overall survival of 24.0 months. (WuXi AppTec)

Animal Study Results of Gene-Editing Therapy VERVE-101 Show Durable Efficacy

On January 13, Verve Therapeutics announced that its gene-editing therapy, VERVE-101, achieved durable and consistent reductions in blood low-density lipoprotein cholesterol (LDL-C) levels for at least six months following a single treatment in non-human primate studies. The company has selected VERVE-101 as its lead product to advance into clinical development, initially targeting heterozygous familial hypercholesterolemia. VERVE-101 is a single-base editing therapy targeting the PCSK9 gene, delivered via engineered lipid nanoparticles, and is designed to permanently reduce patients’ cardiovascular disease risk with a single administration. (WuXi AppTec)

Alphamab Oncology Announces Phase II Clinical Data of KN046 for the Treatment of Non-Small Cell Lung Cancer

Alphamab Oncology to Present Phase II Clinical Data of PD-L1/CTLA-4 Bispecific Single-Domain Antibody KN046 in Patients with Advanced Non-Small Cell Lung Cancer, as Well as Preliminary Safety and Efficacy Data in Patients with Rare Thoracic Tumors, at the Upcoming 2020 World Conference on Lung Cancer. The data demonstrated that KN046 was well tolerated and effective as a second-line treatment for advanced NSCLC, showing benefits in progression-free survival (PFS) and overall survival (OS). In thymic epithelial tumors, the confirmed objective response rate (ORR) for KN046 was 50%, while the confirmed and unconfirmed ORR was 75% (two confirmed partial responses [PR] and one unconfirmed PR), with a disease control rate (DCR) of 100%. (PR Newswire)

Novel Neuromodulation Therapy for Alzheimer’s Disease Receives FDA Breakthrough Device Designation

On January 13, Cognito Therapeutics announced that its flagship product received Breakthrough Device Designation from the U.S. FDA for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The product is a non-invasive neurostimulation device that promotes gamma neural oscillations in the brain and represents the first offering in the company’s digital therapeutic pipeline for neurodegenerative diseases and other chronic indications. (WuXi AppTec)

Bayer’s Finerenone Receives FDA Priority Review Designation

On January 12, Bayer announced that the U.S. FDA had accepted its new drug application and granted priority review designation for the investigational drug finerenone for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes. Previously, finerenone had been granted Fast Track designation by the U.S. FDA. Chronic kidney disease is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease. As the condition progresses, more than one-quarter of patients with diabetes will eventually develop chronic kidney disease, which may even progress to kidney failure. (Immediate Pharma News)

FDA Approves Updated Prescribing Information for Bayer’s Nubeqa

Bayer recently announced that the FDA has approved a supplemental new drug application for Nubeqa, a novel prostate cancer treatment, adding overall survival and other secondary endpoint data from the pivotal Phase 3 ARAMIS trial to Nubeqa’s prescribing information. The data demonstrated that, in patients with non-metastatic castration-resistant prostate cancer, Nubeqa significantly reduced the risk of death by 31% and prolonged patient survival compared with placebo. (Bioon)

MSD’s 15-Valent Pneumococcal Vaccine Granted FDA Priority Review

On January 12, Merck & Co., Inc. (MSD) announced that the U.S. Food and Drug Administration (FDA) had accepted for priority review its Biologics License Application (BLA) for V114, an investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults aged 18 years and older. The FDA has set the target action date under the Prescription Drug User Fee Act (PDUFA) for July 18, 2021. Meanwhile, the European Medicines Agency (EMA) is also reviewing the license application for V114 in adults. (Sina Medical News)

Fosun Pharma: Recombinant Anti-CD38 Fully Human Monoclonal Antibody Injection Approved for Clinical Trials

On January 13, Fosun Pharma announced that its controlling subsidiary, Henlius Biotech, had received approval from the National Medical Products Administration (NMPA) to conduct clinical trials of its developed recombinant fully human monoclonal antibody injection targeting CD38 for the treatment of multiple myeloma. Henlius Biotech and Henlius Pharmaceuticals plan to initiate Phase I clinical trials of this new drug in mainland China (excluding Hong Kong, Macao, and Taiwan) in the near future, once conditions permit. (Fosun Pharma Announcement)

Innovent Biologics: NMPA Accepts New Indication Marketing Application for Tyvyt Combined with Byvasda in the Treatment of Liver Cancer Patients

On January 13, Innovent Biologics announced that the National Medical Products Administration (NMPA) had formally accepted its new drug application for the indication of Tyvyt® (sintilimab), an innovative PD-1 inhibitor, in combination with Byvasda® (bevacizumab biosimilar) for the first-line treatment of patients with liver cancer. This marks the fifth indication application for Tyvyt® and the fourth for Byvasda®. The ORIENT-32 study is a randomized, controlled, open-label, multicenter Phase III clinical trial comparing the efficacy and safety of Tyvyt® combined with Byvasda® versus sorafenib as first-line therapy for advanced liver cancer. The primary endpoints were overall survival and progression-free survival assessed by an independent radiology review committee according to RECIST v1.1 criteria. (PR Newswire)

BeiGene’s PD-1 Inhibitor Receives Approval for Third Indication: First-Line Treatment of Squamous Non-Small Cell Lung Cancer

On January 13, the NMPA website announced the approval of a new indication for BeiGene’s PD-1 monoclonal antibody, tislelizumab. The approved indication is: first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Research results demonstrated that tislelizumab injection combined with chemotherapy for the first-line treatment of advanced squamous NSCLC delivered favorable clinical benefits for Chinese patients with advanced squamous NSCLC compared to conventional chemotherapy regimens, with overall good tolerability and safety profiles. (Insight Database)

Luoxin Pharmaceutical: Parecoxib Sodium for Injection Passes Consistency Evaluation

On January 13, Luoxin Pharmaceutical announced that it had recently received the "Notice of Approval for Supplementary Drug Application" for Parecoxib Sodium for Injection, approved and issued by the National Medical Products Administration (NMPA). Parecoxib sodium is a non-steroidal anti-inflammatory drug (NSAID) indicated for the short-term treatment of postoperative pain. It is the only COX-2 inhibitor worldwide that can be administered both intravenously and intramuscularly. It features effective analgesia, rapid onset, prolonged duration of action, effective inhibition of pain hypersensitivity, high gastrointestinal safety, no impact on platelet function, and no additional increase in cardiovascular risk. (Luoxin Pharmaceutical Announcement)

Kelun Pharmaceutical’s Class 4 Generic Marketing Application for ω-3 Fish Oil Medium/Long-Chain Triglyceride Emulsion for Injection to Be Approved

Recently, data from the NMPA official website shows that Kelun Pharmaceutical’s Class 4 generic marketing application for ω-3 Fish Oil Medium/Long-Chain Triglyceride Injectable Emulsion has entered the “under review” stage, with positive news expected in the near future. According to Menet, currently only B. Braun’s original imported product and Livzon’s domestically produced version hold marketing approvals in China. Upon approval, Kelun will become the second domestic manufacturer. ω-3 Fish Oil Medium/Long-Chain Triglyceride Injectable Emulsion is primarily used as a component of parenteral nutrition to provide fats, including essential ω-6 and ω-3 fatty acids, to adult patients when oral or enteral nutrition is insufficient, contraindicated, or not feasible. The original product was first launched in Europe in 2004 and introduced into the Chinese market via import in 2014. (Menet)

Huiyu Pharmaceutical’s Class 3 Generic Marketing Application for Oxaliplatin Injection Set to Be Approved

Recently, data from the NMPA website shows that Sichuan Huiyu Pharmaceutical's Class 3 generic marketing application for Oxaliplatin Injection has entered the "under review" stage, with positive news expected soon. According to Menet data, oxaliplatin is a major product with annual sales exceeding RMB 3 billion in China's public medical institutions. Currently, among related products, only Qilu Pharmaceutical's Oxaliplatin Injection has been approved under the new classification and is considered to have passed the consistency evaluation. If Huiyu successfully obtains approval this time, it will become the second company to pass the evaluation. Oxaliplatin is a third-generation platinum-based antineoplastic agent, primarily used for first-line treatment of metastatic colorectal cancer and as adjuvant therapy for Stage III colon cancer after complete resection of the primary tumor. (Menet)

GSK’s Single-Dose Tafenoquine Kozenis Class 1 Application Accepted

GSK and MMV recently announced that the Australian Therapeutic Goods Administration (TGA) has accepted their Class 1 application to expand the indication for single-dose Kozenis to the pediatric population, aiming for a radical cure (prevention of relapse) of Plasmodium vivax malaria. Previously, the drug was approved by the TGA in 2018 for individuals aged ≥16 years. For the treatment of active infections, the drug should be administered alongside a course of chloroquine. (Bioon)