National Essential Drug Policy May Undergo Major Adjustment with Triennial Directory Updates

[August 02, 2018 / Pharmaceutical News Overview] The National Essential Medicines List is adjusted every three years; major policy changes to the national essential medicines system may be imminent;Implementing Family Doctor Contract Services at the Grassroots Level: National Health Commission Releases Latest Notice;BGI Genomics Executives Jointly Address “Negative Labels,” Denying Liability in the “Carcinogenesis Scandal”; Daiichi Sankyo’s AML Drug Quizartinib Receives Breakthrough Therapy Designation;2 Billion! Another IVD Company Secures Significant Investment...Daily fresh pharmaceutical news and medical updates, Sudu She keeps you informed! (Click the title to access the original article)

Part 1 Policy Brief

| Implementation of Family Doctor Contracting at the Primary Care Level: National Health Commission Issues Latest Notice

On the 1st, the Department of Primary Health Care of the National Health Commission issued the "Notice on Printing and Distributing the Work Plan for Family Doctor Contract Services for Chronic Diseases Among the Registered Poor Population," making new arrangements for family doctor contracting services for chronic diseases among the impoverished population, clearly defining the tasks of medical institutions at all levels, and providing detailed regulations on chronic disease management. (Primary Care Physicians Community)

| NMPA: Public Disclosure of Information on Medical Device Production and Operation; All Data Uploaded to the Filing System

On the 2nd, the General Office of the National Medical Products Administration (NMPA) issued the “Notice on Strengthening the Management of Licensing Information for the Production and Operation of Medical Devices.” The Notice requires that, effective August 1, the business scope indicated on newly issued Medical Device Operation Licenses and Class II Medical Device Operation Record-filing Certificates shall be divided into two sections: one for the classification codes under the original “Medical Device Classification Catalog” and another for the classification codes under the new “Medical Device Classification Catalog,” with clear labeling. (Sina Pharmaceutical News)

| Catalog to be Adjusted Every Three Years: Major Changes Expected in National Essential Medicine Policy!

Recently, the Department of Drug Policy and Regulation under the National Health Commission drafted the “Opinions on Further Improving the National Essential Medicines System (Draft for Comments).” According to the draft, the key areas for improvement include dynamically adjusting and optimizing the essential medicines list, ensuring reliable production and supply, and reducing the medication cost burden on the public. (Sai Bailan)

| National Health Commission: Myopia Rate to Be Included in Government Performance Evaluation Indicators

The Ministry of Education and the National Health Commission have recently jointly drafted the "Implementation Plan for Comprehensive Prevention and Control of Myopia in Children and Adolescents." The draft stipulates that myopia prevention and control efforts among children and adolescents, overall myopia rates, and physical health status will be incorporated into government performance evaluation indicators. Local people's governments at all levels are strictly prohibited from assessing education administrative departments and schools solely based on students' academic exam scores and school enrollment rates. (China News Service)

| Jiangsu Issues Document: Establishing a System for Regular Inspections of Pharmaceutical Prices

Recently, the Jiangsu Provincial Price Bureau, the Provincial Health and Family Planning Commission, and the Provincial Department of Human Resources and Social Security issued the “Notice on Strengthening Supervision of Pharmaceutical Prices and Regulating Medical Charging Practices.” The notice explicitly states that a regular joint inspection system for pharmaceutical prices will be established to strengthen interim and ex-post supervision. (Medical Observer Network)

Part 2 Listed Companies

| Top Executives Jointly Respond to “Negative Labels”; BGI Genomics Denies Liability in “Cancer Gate”

On the 1st, BGI Genomics held a media open day. Relevant executives from BGI Genomics and BGI Group publicly responded to hot-button issues, including the progress of the Nanjing Changjian case, the company’s R&D talent and investment, and the content involved in the article “BGI Carcinogenesis.” (National Business Daily)

| Jiangzhong Pharmaceutical Abandons Acquisition of Controlling Stake in China Resources Jiangxi

On the evening of July 31, Jiangzhong Pharmaceutical announced its decision to terminate the major asset restructuring and abandon the acquisition of a controlling stake in China Resources Jiangxi Pharmaceutical Co., Ltd., a subsidiary of China Resources Pharmaceutical, opting instead for general acquisitions of two other companies. (Sai Bailan)

| Liquidia Lists on Nasdaq, Completes $50 Million IPO

Liquidia Technologies Announces Completion of $50 Million IPO; Proceeds to Advance Clinical Trials of Two Drug Candidates, LIQ861 and LIQ865 (WuXi AppTec)

Part 3 Investment and Financing

| HealthLi, a One-Stop Medical Equipment Maintenance Service Platform, Secures RMB 85 Million Investment from Winco Capital

On the 2nd, HealthPower Technology announced the completion of an RMB 85 million strategic investment from Yingke Capital. It is reported that HealthPower achieved a revenue growth rate exceeding 100% from 2015 to 2017. (Iyiou)

| ReViral Completes $55 Million Series B Financing

On the 2nd, ReViral, a company headquartered in London, UK, announced the successful completion of its $55 million Series B financing round. ReViral specializes in the development of antiviral drugs for the treatment of diseases caused by respiratory syncytial virus (RSV). (WuXi AppTec)

| 2 Billion! Another IVD Company Secures Significant Investment

On the 1st, Beijing Kemei Biotechnology Co., Ltd. secured RMB 2 billion in investment from investors including China Renaissance and Honghui Capital, potentially setting a new record for the largest single-round financing by an unlisted in vitro diagnostics (IVD) company. (Saibailan Medical Devices)

Part 4 Pharmaceutical and Medical News

| Daiichi Sankyo's AML Drug Quizartinib Receives Breakthrough Therapy Designation

On the 1st, Daiichi Sankyo Co., Ltd. announced that the U.S. FDA had granted Breakthrough Therapy Designation to its oral selective FLT3 inhibitor, quizartinib, for the treatment of relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations. (Sina Medical News)

| Novartis Sells Two Anti-Cancer Drugs to Chinese Pharmaceutical Company Laekna Therapeutics

Novartis Signs Agreement with Shanghai-Based Laekna Therapeutics, Granting Global Exclusive Rights to Two Clinical-Stage Oral Oncology Drugs (Sina Pharmaceutical News)

| RXi Pharmaceuticals Announces Positive Results from Phase 1/2 Trial for Retinal Scarring

Recently, RXi Pharmaceuticals announced positive results from its Phase 1/2 clinical trial (RXI-109-1501) evaluating RXI-109. The trial assessed the safety and tolerability of intravitreal injections of RXI-109 in patients with advanced neovascular age-related macular degeneration (nAMD) accompanied by subretinal fibrosis. (Sina Medical News)

| Salubris’ Blockbuster First Generic Ticagrelor Set for Approval and Market Launch

Earlier, the Insight database showed that the CFDA review status of Salubris’s ticagrelor had changed to “under approval,” and the company has not yet issued an announcement regarding its market approval. However, according to reliable sources, the product has been confirmed as approved, becoming the first generic ticagrelor in China. (Insight Database)

| Priority Review Voucher Trading Hits New Low! Ultragenyx Sells for $80.6 Million

Recently, Kyowa Kirin disclosed that Ultragenyx has sold a Rare Pediatric Disease Priority Review Voucher (PRV), obtained in April, for $80.6 million, with the specific transferee not disclosed. This marks the second time Ultragenyx has sold a PRV. (Sina Medical News)

| Six Medical Device Companies Subjected to Unannounced Inspections by the National Medical Products Administration; Multiple Companies Found with Minor Deficiencies |

Recently, the official website of the National Medical Products Administration (NMPA) released inspection reports on six medical device manufacturers. Among them, Sichuan Hengming Technology, Fangrun Medical, Anpu Li Biology, and Tianrun Biology were found to have multiple general deficiencies and were required to rectify within a specified period; Suzhou Riyuexing Plastics and Longquan Medical have confirmed cessation of production. (Sina Pharmaceutical News)

| 27 Batches of Traditional Chinese Medicine Decoction Pieces Found Non-Compliant

On the 1st, the Gansu Provincial Medical Products Administration released a drug quality announcement, publicly disclosing 27 batches of traditional Chinese medicine (TCM) decoction pieces that failed inspection. For the TCM decoction pieces found non-compliant with regulations, relevant food and drug supervision and administration departments have implemented control measures such as sealing and seizure, required enterprises to suspend sales and use of the products, and mandated corrective actions. (Medical Observer Network)

| Liaoning Announces List of 18 Price-Reduced Drugs

On the 1st, the Liaoning Provincial Centralized Procurement Network for Drugs and Medical Consumables issued the “Notice on Approving Price Reductions for 18 Drugs, Including Paclitaxel Injection Produced by Pfizer Investment Co., Ltd.” After review, it was decided to approve the application for price reductions for 18 drugs produced by Pfizer, including Paclitaxel Injection. (Medical Observer Network)

| Long-term Production Suspension by Pharmaceutical Companies; GMP Certificates for Drugs Revoked

On the 31st, the Jiangxi Provincial Medical Products Administration issued an announcement stating that Jiangxi Gannan Pharmaceutical Co., Ltd. had been out of production for an extended period and no longer met the conditions for pharmaceutical manufacturing or Good Manufacturing Practice (GMP) requirements. Consequently, the provincial administration revoked its "Pharmaceutical GMP Certificate" in accordance with the law. (Medical Observer Network)

| Lyme Disease Spreads to All 50 U.S. States as Infections Surge

News on the 2nd: A newly released research report shows that the incidence of Lyme disease in the United States has risen sharply, and this tick-borne disease has spread to all 50 states. (Global Times)

| Nature Highlight: Chinese Scholars Create Yeast with Only One Chromosome

On the 2nd, Nature published two landmark papers: two research teams successfully fused yeast chromosomes using genome editing. Notably, a team from the Chinese Academy of Sciences created a yeast strain with only one chromosome, marking a major breakthrough in the field of life sciences. (Academic Horizon)

| Latest Research: Per Capita Consumption of Tobacco and Alcohol Is Associated with Cancer Mortality Rates

According to a recent study published in JAMA Network Open, average alcohol intake is associated with total cancer mortality over a 20-year period among older men and women. This study provides evidence that reductions in per capita alcohol and cigarette consumption lead to a decrease in overall cancer mortality. (Bioon)

| Scientists Discover Potential New Targets for Treating Type 2 Diabetes

A study published by researchers at the Karolinska Institutet in the international journal Cell Reports has found that a module within the calcium channels of pancreatic beta cells plays a crucial role in regulating blood glucose levels. Therapies targeting this module could potentially become a new approach to combating type 2 diabetes. (Bioon)

| Scientists Reveal: Genetic Mutations Cause Familial Leukemia

Researchers at the University of California, San Francisco, and St. Jude Children’s Research Hospital in Tennessee have unraveled a medical mystery that has perplexed the field for decades: they identified a set of genetic mutations responsible for familial blood disorders, which can sometimes even lead to leukemia. (BioExplorer)

| Why Does This Study on Blood Pressure and Dementia Risk Lead to Diametrically Opposed Interpretations?

A recent study on blood pressure control and dementia risk has generated considerable excitement in the medical community. Presented at the Alzheimer’s Association International Conference in Chicago, the study demonstrated that intensive blood pressure management significantly reduces the risk of mild cognitive impairment (MCI) as well as the combined risk of MCI and dementia. (Kangjian New Horizons)

| New Discovery: Gut Microbiota May Influence Body Weight

According to a recent article published in Mayo Clinic Proceedings, specific activities of the gut microbiota may aid weight loss in certain populations. This effect is independent of behavioral interventions such as dietary control and regular exercise. (Bioon)

| Memantine May Be a Novel Approach to Preventing Alzheimer’s Disease

Currently, no method has been identified to prevent the onset of this disease. However, researchers from the University of Virginia have discovered molecular signatures associated with its pathogenesis, which emerge prior to phenomena such as neuronal injury. Furthermore, the researchers found that a class of FDA-approved drugs, specifically memantine (currently indicated only for alleviating moderate-to-severe Alzheimer’s disease), may exert inhibitory effects at the early stages of symptom onset. (Bioon)

Part 5 Internet+

| AI Determines Personality Based on Eye Movements

Recently, a study employing state-of-the-art machine learning algorithms to demonstrate the link between personality and eye movements has shown that artificial intelligence can “see” an individual’s personality traits solely based on their eye movement patterns. (BioExplorer)

| South Korea Develops Flexible Electronic Skin

A research team from Seoul National University in South Korea announced the development of a soft robot utilizing a biomimetic electronic skin system. The findings were published in the international academic journal Science Robotics. (Ministry of Science and Technology)