China's First PD-L1 Inhibitor Imfinzi (Durvalumab) Approved for Unresectable Stage III NSCLC

[December 10, 2019 / Pharmaceutical News Overview] The National Drug Use Monitoring Platform Goes Live; 45 Drugs in Wuhan Included in the First Batch of Low-Price Procurement List; Venus MedTech Lists Today; Bendamustine from Chia Tai Tianqing Approved for Launch... Stay tuned with Sudu She for the latest daily pharmaceutical and medical news!

Part 1 Policy Brief

National Drug Use Monitoring Platform Goes Live

The Statistical Information Center of the National Health Commission announced yesterday that the National Drug Use Monitoring Platform has been launched and is now operational. Currently, 8,840 medical and health institutions have completed system login, with the platform averaging 600,000 visits per day. The launch of the “National Drug Use Monitoring Platform” aims to accurately monitor the drug stocking and usage across public medical and health institutions at all levels and types, thereby promoting the priority stocking and use of essential medicines. (National Health Commission)

National Health Commission Issues Classification Standards for Medical Devices

Recently, the official website of the National Health Commission released industry standards for the safety management of medical devices. The standards provide a detailed classification of medical devices and their associated risks. The standard drafting committee, in accordance with relevant national laws and regulations, studied and analyzed the current status of safety management for medical devices used in clinical practice within China’s healthcare institutions, summarized practical experience, and formulated the standards after extensively soliciting feedback from various stakeholders. (National Health Commission)

45 Drugs in Wuhan Included in the First Batch of Low-Price Procurement List

On the 9th, the Wuhan Joint Procurement Office for Pharmaceuticals and Medical Devices released the "Implementation Rules for the First Batch of Centralized Volume-Based Drug Procurement in Wuhan in 2019" and the "Catalogue for the First Batch of Centralized Volume-Based Drug Procurement in Wuhan in 2019," with 45 drugs included in the first procurement catalogue. This catalogue was determined from drugs not covered by national or Hubei Provincial volume-based procurement. The selected varieties were those listed on the "Hubei Provincial Pharmaceutical and Medical Device Centralized Procurement Service Platform" before June 30, 2019, and had transaction volumes in medical institutions in the Wuhan area, as well as Class II psychotropic substances. (Wuhan Joint Procurement Office for Pharmaceuticals and Medical Devices)

Local Medical Insurance Begins Large-Scale Drug List Adjustments

Tianjin Municipal Healthcare Security Administration Recently Issued the “Notice of the Municipal Healthcare Security Administration and the Municipal Human Resources and Social Security Bureau on Aligning with the 2019 Edition of the National Drug Catalogue”According to the notice, Tianjin has removed both the nationally key-monitored drugs and the varieties excluded from the National Reimbursement Drug List (NRDL) in the current round of adjustments from its medical insurance reimbursement list. (Tianjin Municipal Healthcare Security Administration)

New Pharmacy Regulations: 10 Key Regulatory Focus Areas Released

Recently, the Hubei Provincial Medical Products Administration issued the "Notice on Regulating the Business Licensing of Drug Retail Chain Enterprises and Strengthening Supervision and Management (Draft for Comments)." The Notice clearly states that newly established drug retail chain enterprises must have more than 10 directly operated subordinate stores within the province that have been inspected and licensed by the local municipal or county market supervision administrations. (Tianjin Municipal Healthcare Security Administration)

Primary Healthcare Institutions to Launch Traditional Chinese Medicine Services in December

Recently, the Sichuan Provincial Administration of Traditional Chinese Medicine announced that the "Regulations of Sichuan Province on Traditional Chinese Medicine (Revised)" officially came into effect on December 1, 2019. Sichuan has become the first province to promulgate and implement local regulations on traditional Chinese medicine following the National Conference on Traditional Chinese Medicine. In the future, more regions are expected to introduce TCM policies aligned with the new circumstances, offering significant opportunities for TCM practitioners at the grassroots level. (Sichuan Provincial Administration of Traditional Chinese Medicine)

Part 2 Industry and Economic Observations

Venus Medtech Lists Today

Venus Medtech Officially Lists on the Hong Kong Stock Exchange with Stock Code 02500.HKToday, Venus Medtech officially listed on the Hong Kong Stock Exchange, with the stock code 02500.HK. The IPO price was set at HK$33 per share, with a total of 78.5375 million shares issued. The opening price was HK$39 per share, and the market capitalization stood at HK$15.7 billion as of press time. With this listing, Venus Medtech has become the first unprofitable medical device company to be listed under the new standards of the Hong Kong stock market. (Beike Society)

Merck Acquires ArQule, Gaining Second-Generation BTK Inhibitor

Yesterday, Merck & Co. and ArQule jointly announced that they had reached an acquisition agreement. Merck will acquire all publicly traded shares of ArQule through its subsidiary at a price of $20 per share, with the total transaction amounting to approximately $2.7 billion. Among ArQule’s pipeline products is ARQ 531, a competitive novel oral reversible BTK inhibitor currently in Phase II development for the treatment of B-cell malignancies. Through this acquisition, Merck aims to strengthen its oncology portfolio. (PharmaCube)

Sanofi Acquires Synthorx to Bolster Oncology Immunotherapy Pipeline

On the 9th, Sanofi announced that it would acquire all outstanding shares of Synthorx at a price of $68 per share, with the total acquisition amounting to approximately $2.5 billion. Through this acquisition, Sanofi aims to strengthen its oncology immunotherapy product pipeline. The acquisition price represents a 172% premium over Synthorx’s closing price from the previous Friday. Synthorx’s primary immuno-oncology product, THOR-707, is an enhanced version of interleukin-2 and is currently being developed as a monotherapy or in combination with immune checkpoint inhibitors for the treatment of various solid tumors. (Pharmaceutical Cube)

Joinn Biologics Completes $60 Million Series A Financing

Joinn Biologics Officially Closes $60 Million Series A Financing on December 4Joinn Biologics officially closed its $60 million Series A financing round on December 4. The round was led by Huagai Capital, with participation from Nest Bio Ventures, Hong Kong Hualian Holdings, Xiangtang Capital, and other institutions. The funds will be primarily used to build 100,000-liter production capacity at Joinn Biologics’ Beijing facility in China and to expand its business operations in both China and the United States. (Arterial Network)

Yuanji Huayi Announces Completion of Series A Financing

Yuanji Huayi Announces Completion of Series A FinancingRecently, Yuanji Huayi announced the completion of its Series A financing round, led by China Renaissance Holdings and Tencent. With this funding, Yuanji Huayi will continue to deepen its focus on the research, development, and incubation of novel drugs and new technologies in the field of neuroscience. Established in August 2018, Yuanji Huayi is a new drug incubation and R&D platform dedicated to supporting the entire process of original neurological drug development, from laboratory research, preclinical studies, and clinical process design to clinical trials. (YiGu)

Anticancer Innovator Raises $85 Million in Series C Financing

Zentalis Pharmaceuticals, an emerging oncology company, emerged from stealth mode today and secured $85 million in financing. Since its founding in 2014, the company has raised $147 million in development funding, and over the past five years, three anticancer drug candidates have entered clinical development. (Chuangjian Hui)

Part 3 Pharmaceutical News

China's First PD-L1 Monoclonal Antibody Approved for Market Launch

The NMPA has updated the application status of AstraZeneca’s PD-L1 monoclonal antibody Imfinzi (durvalumab; acceptance numbers: JXSS1800040/41) to “Approval Completed – Pending Certificate Issuance.” Imfinzi is now approved for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) that has not progressed following concurrent chemoradiotherapy. This marks the sixth immune checkpoint inhibitor marketed in China and the first PD-L1 monoclonal antibody approved in the country. (Sina Pharmaceutical News)

Chia Tai Tianqing Pharmaceutical’s Bendamustine Approved for Market Launch

On the 10th, the official website of the National Medical Products Administration (NMPA) showed that Chia Tai Tianqing’s new Class 3 generic drug bendamustine (acceptance number: CYHS1600193) has been approved for marketing, indicated for the treatment of non-Hodgkin lymphoma. (Insight Database)

Allist Pharmaceutical’s Third-Generation EGFR-TKI “Aflutinib” Submitted for Market Approval

On the 10th, the marketing application for “Aifutini,” a third-generation EGFR-TKI independently developed by Allist Biopharma, was accepted by the Center for Drug Evaluation (acceptance number: CXHS1900039), making it the third domestically produced third-generation EGFR-TKI to file for market approval in China. (Insight Database)

CDE Plans to Include Amgen’s Bispecific Antibody Blincyto in Priority Review

According to the New Drug R&D Monitoring Database, the Center for Drug Evaluation (CDE) plans to include Amgen’s bispecific antibody Blincyto in the priority review program. Blinatumomab is a BiTE molecule developed by Amgen based on its bispecific T-cell engager platform, simultaneously targeting CD19 and CD3. It is also the first bispecific antibody from the company’s BiTE technology platform to receive FDA approval. (Pharmaceutical Geography)

Positive Clinical Data for BCMA-CD3 Bispecific Antibody

Regeneron previously announced at the ASH annual meeting that its bispecific antibody targeting BCMA and CD3, REGN5458, achieved positive trial data in a Phase 1/2 clinical trial for patients with relapsed/refractory multiple myeloma. REGN5458 is a bispecific antibody targeting BCMA and CD3, developed by Regeneron based on its VelocImmune and VelociBi technology platforms. VelocImmune is a next-generation transgenic mouse platform featuring a humanized B-cell immune system, capable of generating optimized fully human antibodies. (WuXi AppTec)

Positive Phase 2 Data for Precision Cancer Therapy in Rare Immune Diseases

Blueprint Medicines Announces Strong Preliminary Clinical Data from Phase 2 PIONEER Trial of Avapritinib, an Oral KIT and PDGFRα Inhibitor, in Patients with Indolent Systemic Mastocytosis at the ASH Annual Meeting. Serum Tryptase Levels Were Significantly and Rapidly Reduced Across Different Dose Cohorts of Avapritinib. (WuXi AppTec)

US Announces Free HIV Prevention Medication for 200,000 Uninsured Individuals

The U.S. federal government has launched a program called “Ready, Set, PrEP,” which will provide free pre-exposure prophylaxis (PrEP) medications for HIV—Gilead Sciences’ Truvada and Descovy—to 200,000 individuals at high risk of HIV who are not covered by Medicaid, the Veterans Health Administration, or any other federal health program. Meanwhile, the federal government will pay Gilead Sciences approximately $200 per bottle. (Yigu)

Novel Engineered Peptides May Demonstrate Potential for Long-Acting Anti-HIV Activity

Recently, scientists from Fudan University and other institutions have discovered through research that a novel engineered peptide, IBP-CP24, holds promise as a long-acting anti-HIV drug. It can be used alone or in combination with broadly neutralizing antibodies to treat and prevent HIV-1 infection. IBP-CP24 exhibits a prolonged half-life and potentially broad anti-HIV-1 activity, even against drug-resistant strains. (Bioon)

New Study in Nature Portfolio Journal Aids in Overcoming Triple-Negative Breast Cancer

Today, Professor Jin Jian’s research group at the Icahn School of Medicine at Mount Sinai in New York, in collaboration with Professor Ramon Parsons’ group, pioneered the development of MS1943, a highly efficient, selective, and safe degrader of EZH2, targeting methyltransferases. The degradation of the EZH2 protein may represent an effective therapeutic strategy for breast cancer. MS1943 successfully achieved selective degradation of EZH2, and in vitro and in vivo mouse studies demonstrated its efficacy in killing triple-negative breast cancer cells and inhibiting tumor growth. These findings were published in Nature Chemical Biology, a subsidiary journal of Nature. (Academic Horizon)