Recently, Ascletis announced that its independently developed small molecule GLP-1R agonist ASC30 is undergoing two Phase I clinical trials in the United States for the treatment of obesity with monthly subcutaneous injections and daily oral tablets. With the launch of these two Phase I clinical trials, Ascletis has officially entered the field of weight loss drugs. This is another highlight of the pipeline after Ascletis announced in April this year that it would focus on the development of core non-alcoholic steatohepatitis (NASH) drugs. Urgent need for a new engine Like most biotechs, Ascletis has also been moving forward by trial and error. However, Ascletis is luckier than most biotechs. It has become famous for its first local original hepatitis C drug Ganovo, which not only broke the monopoly of multinational companies such as Gilead, AbbVie, Bristol-Myers Squibb, and Merck in the domestic hepatitis C drug market, ...
Starting in June 2024, global scholars concerned with HIV prevention will focus their attention on Gilead’s antiviral drug, lenacapavir. At that time, Gilead released the latest data from the PURPOSE 1 trial, which demonstrated that lenacapavir, when administered via two annual injections, resulted in zero infections compared to daily oral PrEP medications. This suggests that, in the absence of successful vaccine development, lenacapavir could potentially serve as a long-lasting preventive alternative. However, whether the results of the PURPOSE 1 trial were a coincidence or a certainty remains unanswered. In September, Gilead further presented results from the PURPOSE 2 trial, indicating a higher likelihood of certainty. The results showed that 99.9% of participants in the lenacapavir group did not contract HIV, representing a 96% reduction in infection risk compared to the placebo group. This might signal that we are approaching an era of highly effective HIV prevention. 01 / The ...
Recently, Zhendong Pharmaceutical (300158.SZ) was once a partner in arbitration, the amount of claims reached 1.47 billion yuan, almost close to the company’s operating income in the first half of the year. September 9, Zhendong Pharmaceutical announcement shows that the company received on September 7, China International Economic and Trade Arbitration Commission issued the “DE20242588 commissioned production contract dispute arbitration notice”, Beijing Lundy Pharmaceuticals Co. (hereinafter referred to as “Lundy Pharmaceuticals”) filed an application for arbitration with the China International Economic and Trade Arbitration Commission in respect of the contract dispute between Lundy Pharmaceuticals and Zhendong Pharmaceuticals. After the announcement, September 10 to 11, Zhendong Pharmaceuticals shares fell more than 10%, closing price of 3.40 yuan / share on the 11th. Market on both sides of the arbitration situation is also quite concerned about the two sides of the disagreement related to the situation, the “China Business ...
For some time now, the A-share market has been under continuous pressure due to complex internal and external market factors, making it difficult to give full play to resource allocation, value discovery, wealth management and investment functions. No matter how the market evolves and develops, it always has its own laws. Seeing history clearly will help us discover the future. At present, broaden the horizons, calm thinking, help to accurately grasp the historical orientation of the A-share market, see the stock market supply and demand relationship of the marginal improvement, waiting for the active market series of initiatives to accumulate thick into the momentum, landing effect. Recently, the Securities Times launched a series of reports, “Discover the value of A-share investment”, through in-depth interviews and data mining, multi-angle presentation of the A-share market is undergoing positive changes, in order to cohesion of consensus, boost confidence, and jointly promote the A-share ...
Recently, the Guangzhou Municipal Health Commission of Guangdong Province issued the “Ten Measures of the Guangzhou Municipal Health Commission to Support the High-quality Development of Innovative Drugs and Devices”, covering the entire process of product research and development-hospital use-payment expansion. The notice proposes to urge medical institutions to hold at least one working meeting of the medical device-related committee every quarter, and hold a meeting within one month after the publication of the “Guangzhou Innovative Drug and Device Product Catalog”, and promptly include innovative drugs and devices in the medical institution’s drug or device catalog as needed, so as to achieve “all-out allocation” and give priority to selection. Encourage qualified medical institutions to accelerate the application of innovative medical devices such as active surgical instruments, passive implantable devices, medical software, medical imaging, radiotherapy, surgical robots, etc., and orderly promote the iterative upgrade of medical institutions’ equipment and facilities. ...
In September, the 2024 semi-annual reports of various companies have basically been disclosed. According to statistics from Cyber Blue, among the 493 A-share listed pharmaceutical companies (according to the industry classification of Tonghuashun, the same below), the number of companies with year-on-year decline and growth is close to “50-50” – 242 pharmaceutical companies have a year-on-year decline in revenue, accounting for 49% of the total; 252 have an increase in revenue, accounting for 51% of the total. Among the 242 pharmaceutical companies whose revenue decreased compared with the same period last year, 40% of them fell by less than 10%; there were 12 companies with a decline of more than 50%, of which the company with the largest decline had a year-on-year revenue decline of more than 97%. Among the 252 pharmaceutical companies with year-on-year revenue growth, 183 had an increase of less than 20%, accounting for ...
Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China. This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market. Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above. Referring to the progress of Pfizer’s application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the ...
September 10, 2011 – The State Council Information Office held a series of press conferences on the theme of “promoting high-quality development” on the morning of the 10th, Yan Qinghui, deputy director of the State Medical Insurance Bureau, said at the meeting that the medical insurance sector will vigorously promote the expansion of the quality of the collection of medicine and mining. Continuously expand the coverage of collection, carry out a new batch of national organization drugs and high-value medical supplies collection, will be cochlear implants and other high-value medical supplies into the collection. Yan Qinghui introduced, the effectiveness of the collection work can be recognized from three aspects: First, the burden of drug use by the public has been reduced, and the accessibility and quality of drugs have been improved. For example, hepatitis B antiviral drugs entecavir and tenofovir, etc., the annual cost of patients before the ...
By Don Tracy, Associate Editor Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says. Image Credit: Adobe Stock Images/Mohammad Xte The FDA has approved Luye Pharma Group’s Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. According to the company, the treatment is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the United States. The product was granted a US patent in 2023, set to expire in 2039, and was approved as a new drug under the 505(b)(2) pathway.1 The approval is based on results from the company’s pivotal United States study of Erzofri.1 “The purpose of developing innovative formulations is to address unmet clinical needs, which includes covering aspects such as drug efficacy, compliance issues and side effects, among others. With a focus on ...
Guardant Health’s Shield, a liquid biopsy that screens for colorectal cancer by analyzing a patient blood sample, will compete against stool-based tests already established in the market. Shield could also face new competition from other liquid biopsy companies. By Frank Vinluan FDA approval of a Guardant Health blood test that screens for colorectal cancer makes it the first liquid biopsy approved for this type of cancer, clearing the way to make this test more accessible to more people. But commercialization will be a challenge as the new test is not expected to become the first or even second screening option for patients. The approval announced Monday for the test, named Shield, covers the screening of adults age 45 and older at average risk for colorectal cancer. Colorectal cancer is the third most common type of cancer in the U.S., excluding skin cancers, according to the American Cancer Society. For men and women combined, it’s ...
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