Hengrui Medicine Reports H1 2018 Revenue of RMB 7.76 Billion with Nearly RMB 1 Billion Invested in R&D
Ambys Medicines
Liver Disease Treatment Technology Developer
Takeda
Biopharmaceutical Manufacturer
[August 09, 2018 / Pharmaceutical News Overview]Sichuan Province issues document to eliminate all markups on medical consumables within the year; BeiGene announces the completion of its HK$7.1 billion Hong Kong initial public offering; Hisun Pharmaceutical’s Kanamycin Sulfate for Injection is included in the WHO procurement list; Amgen’s new cholesterol-lowering drug approved in China... Stay tuned with Sudu She for the latest daily news in pharmaceuticals and healthcare!(Click the title to access the original text)
Part 1 Policy Brief
On the 9th, it was learned from the Sichuan Provincial Health and Family Planning Commission that Sichuan Province has decided to completely eliminate the markup on medical consumables in public medical institutions within the year, implement zero-markup sales of medical consumables, and simultaneously establish a new compensation mechanism. (Sina Pharmaceutical News)
| New Anti-Corruption Campaign in Pharmaceutical Commerce Hits Association Academic Conferences |
Recently, the State Council issued the "Guiding Opinions on Reforming and Improving the Comprehensive Supervision System for the Healthcare Industry," requiring the establishment of a comprehensive supervision system for the healthcare industry. It explicitly stated that commercial bribery in the pharmaceutical procurement and sales sector will be severely cracked down on, and cases harming public interests will be seriously investigated and dealt with zero tolerance. (E-Pharmaceutical Manager)
| Liuzhou, Guangxi Launches Severe Crackdown on Illegal Drug Recycling
Recently, the Liuzhou Drug Administration issued a notice announcing the launch of a special campaign to crack down on the illegal回收 of pharmaceuticals. The campaign will strictly inspect drug purchase and sales channels, severely punish illegal drug回收 activities, seriously investigate and handle cases involving the procurement of drugs through illicit channels, and rigorously standardize drug purchasing and selling practices. (Pharmaceutical Observer Network)
Part 2 Listed Companies
| ST Changsheng: Shares Held by Controlling Shareholder and Actual Controller Judicially Frozen
On the 9th, Changsheng Biotechnology issued an announcement stating that it learned from the share freezing data queried through the system of China Securities Depository and Clearing Corporation Limited Shenzhen Branch that the company shares held by its controlling shareholder and actual controllers, Gao Junfang and Zhang Youkui, had been judicially frozen. (Sina Medical News)
| BeiGene Announces Completion of Its HK$7.1 Billion Hong Kong Initial Public Offering
On the 9th, BeiGene announced the completion of the previously declared initial public offering in Hong Kong and global equity issuance of 65,600,000 ordinary shares with a par value of $0.0001 per share. (PR Newswire)
On the 9th, Hengrui Medicine released its 2018 semi-annual report. The company’s total assets amounted to RMB 20 billion, representing a year-on-year increase of 11.23%; it achieved operating revenue of RMB 7.76 billion, up 22.32% year on year; and the net profit attributable to shareholders of the listed company reached RMB 1.9 billion, a year-on-year increase of 21.38%. (Sina Medical News)
On the evening of the 7th, Shanghai RAAS announced that its investment business had incurred significant losses due to market fluctuations, with a first-half loss reaching RMB 1.378 billion, a year-on-year decrease of RMB 1.769 billion, resulting in a net profit loss of RMB 855 million for the first half of 2018, representing a year-on-year decline of 220.64%. (Health界)
| Diabetes Drug Prices Continue to Fall, Novo Nordisk's Q2 Performance Declines
Novo Nordisk Releases Q2 2018 Financial Report (Sina Medical News)
Part 3 Investment and Financing
| Ambys Raises $140 Million to Comprehensively Develop Therapies for Advanced Liver Disease
On the 9th, Ambys announced its establishment and the completion of a $60 million Series A financing round. The company is dedicated to the comprehensive research and development of innovative therapies for chronic liver diseases. Simultaneously, Ambys entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited. With financial support from Takeda, the total capital raised by Ambys at its inception has increased to $140 million. (Chuangjianhui)
SQZ Biotech Announces $72 Million Oversubscribed Series C Financing; Funds to Advance Drug Development for Solid Tumors and Autoimmune Diseases, as Well as Preclinical Programs for Type 1 Diabetes (WuXi AppTec)
Part 4 Pharmaceutical News and Medical Updates
On the 9th, Hisun Pharmaceutical (Hangzhou) received a prequalification confirmation letter from the World Health Organization (WHO) regarding Kanamycin Sulfate for Injection. The Kanamycin Sulfate for Injection produced by the company has been included in the WHO’s recommended procurement list. (Sina Medical News)
On the 9th, Tasly announced that it had received the drug clinical trial approval issued by the China Food and Drug Administration (CFDA) for Sanhuang Jingshiming Pills. The product meets the relevant requirements for drug registration and has been approved for clinical trials. (Sina Medical News)
On the 9th, Regenxbio announced promising interim data from the Phase 1 clinical trial of its gene therapy RGX-314 for the treatment of wet age-related macular degeneration. (WuXi AppTec)
| New Lymphoma Drug Poteligeo Approved by FDA for Market Launch
On the 9th, the FDA announced the approval of Poteligeo for marketing, for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome who have received at least one prior systemic therapy. This marks the first FDA approval of a drug specifically for Sézary syndrome. (Sina Medical News)
| Ambys Medicines' TJ103 Injection Approved for Clinical Trials
On the 9th, I-Mab announced that its investigational product, TJ103 injection, recently received the "Drug Clinical Trial Approval" from the National Medical Products Administration. TJ103 is an innovative recombinant human glucagon-like peptide-1 (GLP-1)-Fc fusion protein, with type 2 diabetes as its intended clinical indication. (PR Newswire)
| Amgen’s Cholesterol-Lowering PCSK9 Inhibitor Repatha® Approved in China
On the 8th, Amgen China announced that Repatha® injection had been approved by the National Medical Products Administration on July 31, becoming the first PCSK9 inhibitor approved in China for the treatment of homozygous familial hypercholesterolemia in adults or adolescents aged 12 years and older. (Sina Pharmaceutical News)
| Colorectal Cancer Triple Therapy Receives Breakthrough Therapy Designation from US FDA
On the 7th, Array announced that the combination of BRAFTOVI, MEKTOVI, and cetuximab received Breakthrough Therapy Designation from the U.S. FDA for patients with BRAF V600E-mutant metastatic colorectal cancer who had previously failed one or two prior therapies. (Sina Pharmaceutical News)
| Insmed's Amikacin Liposome Inhalation Suspension for Rare Lung Diseases Receives FDA Approval
On the 7th, Insmed announced that the FDA’s Pulmonary-Allergy Drugs Advisory Committee recognized the safety and efficacy of the company’s ALIS for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex. The committee also endorsed the use of sputum culture conversion as a surrogate endpoint in the Phase 3 CONVERT study. (Sina Medical News)
| Luoxin Pharmaceutical and SYNERGY Pharmaceuticals Reach Licensing Agreement for TRULANCE in China
On the 7th, Luoxin Pharmaceutical announced that it had entered into a licensing agreement with Synergy Pharmaceuticals, granting Luoxin Pharmaceutical exclusive rights to develop and market Synergy’s flagship product, TRULANCE, for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults, in mainland China, Hong Kong, and Macau. (E-Pharma Manager)
| Paratek's Novel Broad-Spectrum Antibiotic Gains Support from US FDA Committee
Paratek Announces FDA Advisory Panel Support for Approval of Modified Tetracycline Omadacycline for Acute Bacterial Skin Infections and Community-Acquired Pneumonia (Sina Pharmaceutical News)
| WHO Recommends Dolutegravir as the Preferred First-Line Treatment for HIV/AIDS
The World Health Organization recently updated its guidelines on HIV prevention and treatment, recommending dolutegravir as the preferred first-line antiretroviral regimen for adults and adolescents. (Xinhua News Agency)
On the 9th, the Center for Drug Evaluation (CDE) released the "Public Notice on Drug Registration Applications Proposed to Be Included in the Priority Review Procedure." After review and evaluation of drug registration applications requesting priority review, the CDE publicized the applications proposed for priority review along with their applicants. (Sina Pharmaceutical News)
On the 8th, the Center for Drug Evaluation (CDE) released the "Notice on Soliciting Opinions on the List of Clinically Urgent New Drugs Already Marketed Abroad." The notice stated that it had selected a list of 48 clinically urgent new drugs already marketed abroad, including Alectinib Hydrochloride. For these drugs, applicants may submit or supplement all research data obtained overseas and supporting materials demonstrating no ethnic differences, and directly file marketing applications. (Sina Pharmaceutical News)
| Top 20 Drug Procurement Amounts in Fujian
On the 7th, the Fujian Provincial Drug Procurement Center released the top 20 drugs by sales revenue under the joint price-capped transparent procurement program. The table shows that products from foreign pharmaceutical companies account for a slightly larger share. (Yiyao Guanchajia Network)
| First Generic Drug Approved by FDA Under New CGT Legislation
Today, the FDA announced the approval of several different strengths of potassium chloride oral solution from Apotex, marking the first generic drug approved through the “Competitive Generic Therapy” (CGT) designation. This new approval pathway aims to accelerate the development and review of generic drugs for which there is a lack of competitive products. (WuXi AppTec)
| NMPA Orders This Medical Device Company to Immediately Suspend Production for Rectification
On the 8th, the National Medical Products Administration (NMPA) issued a notice regarding an unannounced inspection of Debang Deli Company, conducting a for-cause inspection of the company’s semiconductor laser treatment machines, carbon dioxide laser treatment machines, and other products. The NMPA directed the Shanghai Food and Drug Administration to legally order the enterprise to immediately cease production for rectification. (Sina Pharmaceutical News)
| Chinese Researchers Discover Cancer Cells Release “Drones” to Paralyze the Immune System
On the 9th, a groundbreaking study was published in Nature. A multinational research team discovered an astonishingly cunning aspect of cancer cells. To suppress the immune system, they release “drones” to remotely interfere with the activity of immune cells! (Academic Horizon)
| Scientists Successfully Unveil the Origin and Transmission Patterns of the Hepatitis B Virus
Recently, a newly published research study has elucidated the geographic origins and global transmission patterns of two types of hepatitis B virus, revealing significant differences in the global dissemination patterns of these two HBV subtypes. (Bioon)
| Breakthrough! A Gene Once Thought to Be Oncogenic May Actually Be a Tumor Suppressor
A research report published in a journal recently revealed that the gene PLK1, long considered a tumor initiator for decades, actually performs the exact opposite function. The evaluation of PLK1 as a target for developing potent anticancer drugs may need to be reconsidered, depending on the type of cancer being treated. (BioValley)
| Low-Protein Diet During Pregnancy May Increase the Risk of Prostate Cancer in Offspring
A study conducted by the Institute of Biosciences of São Paulo State University in Brazil on rats showed that maternal low-protein diet impairs prostate growth in offspring and leads to the development of prostate cancer. (BioExplorer)
| Nat Commun: Key molecules may help sperm quickly locate eggs
Recently, a research report published in an international journal revealed that scientists from the Marine Biological Laboratory in the United States identified a key molecule driving chemotaxis between sperm and egg cells in marine invertebrates. (Bioon)
| Nat Microbiol: Using Computer Simulations to Predict the Spread of HIV in Populations
In a new study, researchers from Los Alamos National Laboratory in the United States have confirmed that computer simulations can accurately predict the spread of HIV in populations, which may help prevent this viral infection. (Bioon)
| Research Finds: A Novel Molecular Probe Leaves Cancer Stem Cells Nowhere to Hide
In a new study, researchers have developed a molecular probe to identify and illuminate cancer stem cells, enabling their identification, tracking, and study not only in vitro cell cultures but also within their native environment in the body. (Bioon)
Major Breakthrough! Immunofluorescence Imaging Technology Upgraded
In a new study, researchers have developed a novel method for analyzing cells and their components, termed iterative indirect immunofluorescence imaging. This innovative approach significantly improves upon the standard immunofluorescence imaging techniques used in biomedicine and provides clinicians with extensive data from each sample. (Bioon)
| Study Finds: A Potential New Drug May Reduce Cardiovascular Disease Risk Through Targeted Action
Recently, scientists have designed a novel drug that may reduce the risk of cardiovascular disease by targeting specific microbial pathways in the gut. The drug inhibits gut microbiota from producing harmful molecules associated with heart disease, without killing these microbial communities. (Bioon)
| Aging: Novel compounds can reverse cellular aging trends
Recent research findings from the University of Exeter have revealed that drug treatment can reduce the degree of cellular senescence by 50%. Furthermore, the authors identified that two intracellular division factors play a significant role in the aging process of endothelial cells. (Bioon)
| Cytomegalovirus May Alter Host Immune Responses to Vaccines and Pathogens
Recently, scientists have discovered through research that low levels of cytomegalovirus can significantly affect the body's microbiota and immune cell populations. Meanwhile, researchers have also elucidated the manner and molecular mechanisms by which the body's immune system responds to influenza virus vaccines. (BioValley)
| Targeting Regulatory T Cells: Novel Targeted Drugs Show Potential for Immunotherapy |
Researchers at the Kimmel Cancer Center of Johns Hopkins University have recently discovered a method to inhibit Treg activity. They found that a protein called Yes-associated protein plays a role in suppressing the anti-tumor activity of Tregs. (WuXi AppTec)
Part 5 Internet+
On the evening of the 8th, an internal email from Martin, founder of Ambys Medicines, a representative enterprise in internet healthcare, quickly circulated. The email stated that Ambys Medicines would merge with Penguin Doctor, and the new group company would be collectively known as “Penguin Ambys.” (Sina Medical News)
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.