On November 1, Aimei Vaccine announced that it has submitted a drug market registration application for its self-developed 13-valent conjugate pneumococcal vaccine to the National Medical Products Administration. The results from a completed Phase III clinical study show that Aimei’s 13-valent conjugate pneumococcal vaccine has demonstrated good immunogenicity and safety, meeting the clinical preset objectives. Aimei’s wholly-owned subsidiary, Aimei Biotechnology Co., Ltd., has obtained the corresponding drug production license for this product. The 13-valent conjugate pneumococcal vaccine has been referred to as the “king of global vaccines” and has been the world’s top-selling vaccine for ten consecutive years. Pfizer’s 13-valent conjugate pneumococcal vaccine (Prevnar 13®) is the best-selling vaccine globally and has frequently ranked among the top ten best-selling drugs worldwide. According to Pfizer’s 2023 annual report, global sales of Pfizer’s pneumococcal conjugate vaccine were approximately $6.44 billion in 2023. Over the years, the global sales of the 13-valent conjugate ...
In 2022, Pfizer’s annual revenue exceeded $100 billion, making it the world’s largest pharmaceutical company in terms of revenue. However, as the COVID-19 pandemic quickly receded, revenue fell by 41% in 2023, and revenue ranking also dropped from first to fourth. Recently, the well-known radical investment institution Starboard Value invested $1 billion in Pfizer. What changes will this bring to this pharmaceutical giant? In 1849, Charles Pfizer and Charles Erhart founded Pfizer in New York, initially focusing on the production of chemical products. During World War II, Pfizer successfully mass-produced penicillin and launched oxytetracycline, officially entering the pharmaceutical industry. Since then, Pfizer has continued to expand through research and development and mergers and acquisitions, launched blockbuster drugs such as Norvasc and Viagra, and gradually became a leading global pharmaceutical company. Since the 21st century, Pfizer has topped the list of the top 50 pharmaceutical companies in the world (Pharm Exec ...
Yesterday (October 14), the official website of the National Medical Products Administration (NMPA) announced that the Sacubitril Valsartan Sodium Tablets submitted by Shandong New Era Pharmaceuticals were approved and passed the review. Sacubitril Valsartan Sodium Tablets is an antihypertensive drug used for adult patients with chronic heart failure with reduced ejection fraction. As the world’s first breakthrough innovative drug in the field of heart failure treatment, Sacubitril Valsartan Sodium Tablets entered the Chinese market in 2017 for the treatment of heart failure, and was later included in the 2020 National Medical Insurance Catalogue. In June 2021, it was first approved in China for the treatment of essential hypertension. In 2021, in-hospital sales exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%. According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. In the subdivided ...
Recently, Ascentage Pharmaceuticals’ APG-2449 has obtained CDE approval and will conduct two registered Phase III clinical studies for the treatment of non-small cell lung cancer. APG-2449 is a small molecule FAK inhibitor independently developed by Ascentage Pharmaceuticals with oral activity. It is a third-generation ALK/ROS1 TKI and the first FAK inhibitor in China to be approved by CDE for clinical trials. This may mean that the node for domestic drugs to disrupt the ALK target pattern is getting closer and closer, and it also indicates that the next blockbuster product of China’s innovative drugs is on the way. The saying “He who gets lung cancer gets the world” is widely circulated in the field of tumors. Lung cancer is the leading cause of morbidity and mortality of malignant tumors in China. The large number of lung cancer patients has always been a must-fight place for pharmaceutical companies. This is also ...
Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
Vertex (Futai Pharmaceuticals) has a long-standing reputation. It has worked in the field of rare diseases for more than ten years and has created an orphan drug blockbuster trikafta with annual sales of over $10 billion. Today, the company has opened up new horizons in another field. Recently, Vertex announced that the FDA has accepted the marketing application of the Nav1.8 inhibitor VX-548 (Suzetrigine) and granted priority review qualification for the treatment of moderate to severe acute pain. This is a major breakthrough in the field of analgesics and may subvert the competitive landscape of analgesics commercialization. Analgesics have always been valued by the medical community, both in academia and industry. And every pharmacology textbook and medicinal chemistry textbook used as a teaching material cannot avoid a classic drug: morphine. Whether it is its rigid structure of five fused rings or its analgesic and antitussive pharmacological effects, it is well ...
Since the discovery of cyclin-dependent kinases (CDKs), scientists have been trying to target them to disrupt cancer cell division and proliferation. Breast cancer in particular relies on this process to grow. Because of this, the first-generation CDK inhibitors targeting CDK4 and CDK6 have been very successful. In February 2015, palbociclib, the first CDK4/6 inhibitor developed by Pfizer, was approved for marketing in the United States for the treatment of locally advanced or metastatic breast cancer of HR/HER2-. There are many breast cancer patients, and in 2020, there were more than 2.3 million new breast cancer patients in the world, making it the world’s largest cancer type. Based on the large patient size, the sales scale of palbociclib is also considerable. In 2016, the sales of palbociclib in the first full year of marketing reached 2.135 billion US dollars, becoming a well-deserved blockbuster drug. Since then, CDK4/6 inhibitors of Eli ...
On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
Recently, the Lasker Award, an important award in the field of biomedicine known as the “vane” of the Nobel Prize, was announced. Among them, the “Clinical Medical Research Award” was awarded to Joel Habener (Massachusetts General Hospital), Lotte Bjerre Knudsen (Novo Nordisk) ) and Svetlana Mojsov (Rockefeller University). The reason for the award is that they discovered and developed GLP-1-based drugs, which revolutionized the treatment of obesity. GLP-1, glucagon-like peptide-1, is a peptide hormone encoded by the human glucagon gene and secreted by intestinal L cells. It can promote the synthesis and secretion of insulin and suppress appetite. Delaying the emptying of gastric contents, etc. Representative products include Novo Nordisk’s semaglutide and Eli Lilly’s tilpotide. It is worth mentioning that the research on GLP-1 has not only received attention from academic awards, but also brought “vast wealth” to companies in the industrial chain due to the huge market demand. The ...
Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
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