On January 24th, the Center for Drug Evaluation of the National Medical Products Administration released a correction statement, aiming at the problem of data duplication existing in individual varieties publicly disclosed on the website of the Center for Drug Evaluation of the National Medical Products Administration. After verification, it was due to editing errors when disclosing relevant product information in 2019 and 2021. The wrong information has been corrected on the center’s website as soon as possible. The details of the statement are as follows: Recently, the Center for Drug Evaluation of the National Medical Products Administration received reports from relevant media and enterprises that there were problems of data duplication in individual varieties publicly disclosed on the website of the Center for Drug Evaluation of the National Medical Products Administration. The Center for Drug Evaluation of the National Medical Products Administration immediately verified the data of relevant varieties. After ...
As the national biopharmaceutical alliance’s centralized procurement approaches, the biosimilar market is facing a major transformation. On January 14, 2025, the Anhui Provincial Medical Insurance Work Conference clearly stated that it would take the lead in the national biopharmaceutical alliance’s centralized procurement. This move is regarded as an “upgraded version” of biopharmaceutical centralized procurement, covering a wider range of varieties, a larger market scale, and more intense bidding. After the news of the centralized procurement spread, the stock prices of relevant pharmaceutical companies fluctuated. For example, the stock price of Innovent Biologics plummeted by 14% at one point after the news was announced, and the decline at the close was 10.16%. Nevertheless, relevant companies have stated that the centralized procurement has a limited impact on overall revenue, and the companies are planning the launch of new drugs to cope with market changes. Innovent Biologics, Shanghai Henlius Biotech, Junshi Biosciences, etc. ...
On January 24th, an online article “A large number of similar data in the consistency evaluation of generic drugs” caused a heated discussion. The author gave three varieties as examples, such as rosuvastatin calcium tablets, where the bioequivalence test data of the two production enterprises, Nanjing Chia Tai Tianqing and Lek Pharmaceuticals d.d, were completely the same; among the 6 generic drugs that passed the consistency evaluation of trametazidine hydrochloride tablets, the data of Hubei Sihuan and Grand Pharma also appeared to be the same; and the BE fasting data of metformin hydrochloride tablets of Guizhou Tian’an Pharmaceutical was consistent with the data of Shanghai Shangyao Xinyi Pharmaceutical Factory. The author also stated in the article that it is very difficult and requires very high standards for a generic drug to pass the consistency evaluation formally. There are tens of thousands of generic drugs in our country, and only 1,988 ...
On January 24, Novo Nordisk, the Danish pharmaceutical giant, announced the latest trial results of the new weight – loss drug Amycretin. This drug can, on average, help patients lose 22% of their body weight, outperforming Semaglutide, which the company is currently marketing. Boosted by this news, Novo Nordisk’s shares on the US stock market opened with a surge of over 10% on Friday. As of the time of writing, the increase had dropped back to over 8%. The trial results showed that Amycretin is administered by injection. After 36 weeks, the average body weight of obese and overweight patients decreased by 22%. In contrast, patients using a placebo during the same period gained 2.0% in body weight. This trial involved 125 overweight or obese patients. The most common side effect was gastrointestinal discomfort, and most of the side effects were evaluated as “mild to moderate”. Compared with the already ...
On January 24, it was reported that Chengda Biotech (688739) announced that the application for marketing approval of the quadrivalent influenza virus split vaccine developed by its wholly – owned subsidiary, Chengda Biotech (Benxi) Co., Ltd., for domestic drug production and registration had recently received the “Acceptance Notice” from the National Medical Products Administration. This vaccine is used to prevent influenza caused by influenza viruses of vaccine – related types. It has good safety and immunogenicity and can stimulate the body to produce immunity against influenza viruses. If the quadrivalent influenza vaccine is successfully approved for marketing, it will enrich the company’s product pipeline, enhance the company’s core competitiveness, and lay a foundation for the company’s sustainable and stable development. At the same time, the announcement pointed out that the acceptance of this application will not have a significant impact on the company’s recent performance. In addition, the review and ...
On the evening of June 30, 2021, Eli Lilly (688578.SH) and ArriVent Biopharma, Inc. (hereinafter referred to as “ArriVent”) announced a deal regarding its core product, furmonertinib mesylate tablets (hereinafter referred to as “furmonertinib”). Eli Lilly granted ArriVent the exclusive development and commercialization rights of furmonertinib overseas (excluding the Chinese mainland, Hong Kong, Macau and Taiwan regions). Through this deal, Eli Lilly received an upfront payment of $40 million, with cumulative milestone payments for R & D and sales and sales royalties of no more than $765 million. More importantly, Eli Lilly acquired a certain percentage of ArriVent’s shares, and ArriVent became an associated company of Eli Lilly. At that time, Eli Lilly had just been listed on the Sci-Tech Innovation Board for half a year, and ArriVent was also a new company that had just completed its first round of financing, raising tens of millions of dollars. In the ...
“Hainan Haiyao (000566) has issued an announcement, expecting a net profit loss ranging from 900 million to 1,300 million yuan for 2024, compared with a loss of 106.4886 million yuan in the same period last year. The expected loss of non-recurring net profit is from 700 million to 1,000 million yuan, while in the same period last year, it was a loss of 410.1863 million yuan. The expected loss per basic share is from 0.6937 yuan/share to 1.002 yuan/share, as opposed to a loss of 0.0821 yuan/share in the same period last year. The operating income is expected to be between 1,000 million and 1,200 million yuan, compared with 1,480 million yuan in the same period last year. The main reasons for the performance changes: The estimated amount of impairment losses on assets and credit impairment losses in this reporting period is approximately -700 million yuan, mainly due to the ...
“Recently, the “Yiguanjian Granules” developed by Shanghai Kaibao Pharmaceutical Co., Ltd. were approved by the National Medical Products Administration for marketing, becoming the first 3.1-type new Chinese medicine in Shanghai derived from an ancient classical prescription. In 2018, the National Administration of Traditional Chinese Medicine, in conjunction with the National Medical Products Administration, announced the “Directory of Ancient Classical Prescriptions (First Batch)”, which included a total of 100 prescriptions, with “Yiguanjian” being listed among them. After more than 6 years of research and development, this classic prescription has regained new vitality and been transformed into a modern preparation with stable quality, good safety, and convenient administration. In recent years, the National Administration of Traditional Chinese Medicine has organized and promoted the research work on the key information verification of ancient classical prescriptions, and jointly with the National Medical Products Administration, announced three batches of the “Directory of Ancient Classical Prescriptions”, ...
Recently, Pien Tze Huang’s 2024 performance report was released. In 2024, the company achieved total operating revenue of approximately 10.769 billion yuan, an increase of 7.06% compared with 10.058 billion yuan in the same period of the previous year. The net profit reached 2.974 billion yuan, an increase of 6.32% compared with 2.797 billion yuan in the same period of the previous year. In terms of performance growth rate, in 2023, Pien Tze Huang’s operating revenue increased by 15.69% year – on – year, and the net profit increased by 13.15% year – on – year. In 2024, the performance growth rate of Pien Tze Huang slowed down. Looking at single – quarter performance, in the fourth quarter of 2024, Pien Tze Huang achieved operating revenue of 2.32 billion yuan, a year – on – year decrease of 5.7%; the net profit was 290 million yuan, a year – on ...
On the morning of January 22, Lepu Biopharma (02157.HK) announced a global exclusive licensing agreement with ArriVent BioPharma, Inc. (AVBP.O, hereafter referred to as ArriVent) for an antibody-drug conjugate (ADC) called MRG007, aimed at gastrointestinal cancers. The company’s stock opened over 13% higher in the morning, and as of the time of publication, it rose 7.95% to HKD 2.58/share. According to the agreement, Lepu Biopharma grants ArriVent the global exclusive license to develop, manufacture, and commercialize MRG007 in regions outside Greater China (which includes mainland China, Hong Kong, Macau, and Taiwan). Lepu Biopharma will receive a total upfront payment of $47 million, with upcoming milestone payments, and up to $1.16 billion for development, registration, and sales-related milestone payments, as well as tiered royalties based on net sales outside Greater China. Lepu Biopharma announced that MRG007 showed strong anti-tumor activity in preclinical models of gastrointestinal cancers and demonstrated a high therapeutic ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.