Yangtze River Pharmaceutical Submits First Class 1 Chemical NDA for Sodium Phospholevornidazole Injection
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[August 15, 2019 / Pharmaceutical News Overview]CStone Pharmaceuticals Announces H1 2019 Financial Results; Death Penalty for Drug Law Violations, Whistleblowers to Receive 7-Fold Reward; New Anti-Tuberculosis Drug Approved by FDA, Fosun Pharma Conducting Clinical Trials in China; CHIATAI TIANQING to Secure First Generic Approval for Fosaprepitant Dimeglumine... Stay tuned with Sudu She for the latest pharmaceutical and medical news!(Click the title to access the original text)
Part 1 Policy Brief
| Price Coordination Across 14 Provinces Levels the Playing Field for High-Value Consumables |
On August 14, a document issued by the Shaanxi Provincial Healthcare Security Administration, titled “Notice on Soliciting Opinions on the Proposed List of High-Value Medical Consumables for Centralized Volume-Based Procurement,” circulated within the industry. The document stated that, to fully leverage the scale and technical advantages of the alliance, promote cross-regional joint volume-based procurement, and further reduce the prices of high-value medical consumables, it is proposed to launch centralized volume-based procurement of high-value medical consumables through the inter-provincial procurement alliance. (Saibailan Medical Devices)
| Hebei Province Expands the Scope of Practice for Traditional Chinese Medicine
The Hebei Provincial Administration of Traditional Chinese Medicine and the Health Commission recently jointly issued a notice clarifying that physicians not categorized under traditional Chinese medicine (TCM), upon assessment by their practicing institutions and confirmation that their TCM professional technical skills have reached the corresponding level, may provide four types of TCM services in clinical practice: Chinese patent medicines, TCM preparations produced by medical institutions, appropriate TCM technologies, and TCM decoction pieces. (Xinhua News Agency)
Recently, the General Office of the State Council issued the “Plan for the Division of Key Tasks from the National Teleconference on Deepening the ‘Streamline Administration, Delegate Power, and Improve Services’ Reform to Optimize the Business Environment.” The Plan pointed out that the time required for enterprise registration should be further reduced, to within five working days by the end of 2019, and to within three working days in regions with the necessary conditions. (Pharmacy Manager)
Recently, the Hainan Provincial Market Supervision Administration issued the "Implementation Measures for Rewarding Reports on Food and Drug Safety in Hainan Province (Draft for Comments)." It clearly states that rewards for reporting violations of food and drug laws can reach up to 500,000 yuan. Moreover, if the reported party is held criminally liable, the reward will be doubled; in cases where the death penalty is imposed, a sevenfold reward will be granted directly. (Pharmacy Manager)
Part 2 Industry Observation
| CStone Pharmaceuticals Announces First Half 2019 Financial Results
On August 15, CStone Pharmaceuticals announced its interim results for the period ended June 30, 2019. Under International Financial Reporting Standards (IFRS), other income amounted to RMB 28.62 million, representing a year-on-year increase of 6.16 times. This significant growth in other income was primarily attributable to interest income from bank deposits and time deposits, as well as gains arising from changes in the fair value of money market funds. Research and development expenses totaled RMB 384 million. (PR Newswire)
| Health tech startup Doxper completes $4 million Series A funding round
August 15 News: Health startup Doxper has raised $4 million in Series A funding. In a statement, Doxper said that in addition to investing in technology and R&D, the funds will also be used to expand its presence in the Chinese market. (Arterial Network)
| D&D Pharmatech Completes $137 Million Series B Financing to Develop Innovative NASH Therapies
D&D Pharmatech Announces Completion of $137 Million Series B Financing RoundD&D Pharmatech has announced the completion of a $137 million Series B financing round. The proceeds from this financing will be used to advance Neuraly, a subsidiary of the company, in moving its clinical candidate for the treatment of neurodegenerative diseases into Phase 2 clinical trials; to support Precision Molecular in advancing its neuroinflammation imaging agent into Phase 1 and Phase 2 clinical trials; and to enable Theraly to progress its preclinical candidate for the treatment of fibrotic diseases into Phase 1/2 clinical trials. (WuXi AppTec)
Part 3 Pharmaceutical and Medical News
On August 15, the Center for Drug Evaluation (CDE) of the National Medical Products Administration accepted the marketing application for Yangtze River Pharmaceutical Group’s first Class 1 chemical new drug, Disodium Levornidazole Phosphate Ester for Injection (acceptance number: CXHS1900022). The indication for this new drug is gynecological pelvic inflammatory diseases. (Sina Pharmaceutical News)
On the 15th, AstraZeneca announced two significant R&D advancements. First, Lynparza, a blockbuster PARP inhibitor co-developed with Merck & Co., in combination with bevacizumab as first-line maintenance therapy, met its primary endpoint in a Phase 3 clinical trial for patients with advanced ovarian cancer. Meanwhile, AstraZeneca announced that Calquence, a Bruton’s tyrosine kinase (BTK) inhibitor, had been granted Breakthrough Therapy Designation by the FDA as a monotherapy for adult patients with chronic lymphocytic leukemia. (WuXi AppTec)
| Regeneron’s New Drug Evinacumab Reduces LDL Levels by 49% |
On the 15th, Regeneron announced that evinacumab, which targets the innovative target angiopoietin-like protein 3 (ANGPTL3), achieved positive results in a pivotal Phase 3 clinical trial. The trial data demonstrated that, compared with existing lipid-lowering therapies, evinacumab reduced LDL cholesterol levels by 49% in patients with homozygous familial hypercholesterolemia (HoFH) and was well tolerated. (WuXi AppTec)
| New Anti-Tuberculosis Drug Approved by FDA; Fosun Pharma Conducting Clinical Trials in China
On August 14 (local time), the U.S. FDA announced approval of Pretomanid in combination with Bedaquiline and Linezolid for the treatment of patients with extensively drug-resistant tuberculosis (XDR-TB) or those who are intolerant or non-responsive to multidrug-resistant tuberculosis (MDR-TB) therapy. This marks the third new anti-tuberculosis drug approved by the FDA in nearly 40 years. (Sina Medical News)
On August 14, biopharmaceutical company Pharming Group announced an agreement with Novartis to jointly develop and commercialize CDZ173, a therapeutic drug for immunodeficiency disorders. Upon completion of this collaboration, Pharming will obtain the exclusive license for the drug, enjoying its sole distribution rights. (Arterial Network)
| Another Docetaxel Specification from Huiyu Pharmaceutical Passes Consistency Evaluation
Recently, another specification (4ml:80mg) of Docetaxel from Huiyu Pharmaceutical passed the consistency evaluation. Previously, the company's Pemetrexed was approved for production under the new Category 4 application, making it the first enterprise to pass the evaluation for injectables. According to data from Menet, the domestic market for Pemetrexed and Docetaxel combined exceeds ten billion yuan, with Hansoh and Hengrui dominating the market respectively. (Menet)
AstraZeneca Recently Announces Positive Overall Survival Results from the Phase III FLAURA Study of Targeted Anti-Cancer Drug Tagrisso (Chinese Brand Name: Taisisha; Generic Name: Osimertinib) for Lung Cancer. Based on these results, Tagrisso is the only drug to demonstrate a statistically significant overall survival benefit in the first-line treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer. Additionally, Tagrisso also extended progression-free survival in patients with central nervous system metastases. (BioValley)
| CHIATAI TIANQING to Secure First Generic Approval for Fosaprepitant Dimeglumine
Recently, the approval status of CHIATAI TIANQING’s marketing application for Fosaprepitant Dimeglumine has changed to “Under Review,” and the drug is highly likely to be launched this month. Fosaprepitant Dimeglumine was developed by Merck Group and is the phosphate prodrug of Aprepitant. Currently, neither the originator product nor any generic versions have been marketed in China. Since receiving clinical trial approval in 2014, the originator product has seen no further progress. Three companies—CHIATAI TIANQING, Hansoh Pharmaceutical, and Qilu Pharmaceutical—have all submitted marketing applications, with CHIATAI TIANQING making the fastest progress. (CPhI Online)
| Sanofi’s Innovative RNAi Therapy Approved for Clinical Trials in China
On August 13, the Center for Drug Evaluation of the National Medical Products Administration released its latest public notice, indicating that the clinical trial application for fitusiran injection, an investigational new drug under development by Genzyme, a Sanofi company, has received implicit approval. The indicated use is for the prevention or reduction of bleeding episodes in adult and adolescent patients aged 12 years and older with hemophilia A or B, with or without inhibitory antibodies. (Yiyao Guanlan)
| Leaders of Two Hospitals in Yunnan Expelled from Party and Public Office on the Same Day |
On August 12, according to the website of the Chuxiong Yi Autonomous Prefecture Commission for Discipline Inspection and Supervision in Yunnan Province, Liu Xiaoming, former Deputy Secretary of the Party Committee and President of Chuxiong Prefecture People's Hospital, was expelled from the Communist Party of China and dismissed from public office due to serious violations of discipline and law. On the same day, the website released another announcement: Yang Benlei, former Secretary of the Party Committee and President of Chuxiong Prefecture Traditional Chinese Medicine Hospital, was also expelled from the Communist Party of China and dismissed from public office for serious violations of discipline and law. (Kan Yijie)
| FDA Classifies Fresenius Kabi USA’s Recall of Infusion Devices and Software as Class I Recall
On August 12, the U.S. FDA announced that the recall of infusion devices and software by Fresenius Kabi USA was classified as a Class I recall, the most serious type of recall. (Medical Representative)
Scientists at Georgia State University have recently discovered that blocking the ability of the gonorrhea pathogen to absorb the mineral zinc could potentially prevent the widespread sexually transmitted infection it causes. These findings will help researchers develop new gonorrhea vaccines and effectively inhibit the growth of the gonorrhea pathogen. (Bioon)
*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.