PharmaFocus Today – Page 146 – media

Livzon Group’s Recombinant Human Follicle – Stimulating Hormone Accepted by the Drug Administration

On January 26, it was reported that Livzon Group (000513/01513) announced that the application for domestic drug production registration of the recombinant human follicle – stimulating hormone injection developed by its holding subsidiary, Zhuhai Livzon Mab Biotech Co., Ltd., has been accepted by the National Medical Products Administration. The specification of the accepted drug is 33μg (450IU)/0.75mL, and the registration category is 3.3 for therapeutic biological products. According to the announcement, the cumulative R & D cost of the recombinant human follicle – stimulating hormone injection has reached 104 million yuan. The announcement mentioned that the indications of the recombinant human follicle – stimulating hormone injection include anovulatory women, superovulation in assisted reproductive technology, and patients with severe luteinizing hormone and follicle – stimulating hormone deficiencies. The market demand for the drug has been continuously increasing due to the annual rise in the domestic infertility rate. In 2023, the domestic ...
- Source: drugdu
- 289
- February 4, 2025
Can Shanghai Prescribe Original – Research Drugs for Hypertension? Many Clinicians Reveal the True Situation of “Drug Shortage”

Recently, a piece of news that “Shanghai hospitals have received notice that original – research drugs for hypertension can be prescribed” has been spreading online. However, some patients who went to the hospital said, “We still can’t get imported drugs.” What exactly is going on? A reporter from Yicai Global interviewed many clinicians from top – tier hospitals and community hospitals in Shanghai. It was learned that there are more than a dozen imported original – research drugs for hypertension that can be prescribed in large hospitals. However, the mechanisms and curative effects of these drugs are not all the same. For some popular hypertension drugs, such as Pfizer’s amlodipine besylate tablets, the original – research drug “Norvasc”, there is indeed an imbalance between supply and demand. There may be a situation of “no drugs available” in general outpatient clinics. On January 24th, the reporter from Yicai Global learned from ...
- Source: drugdu
- 367
- February 4, 2025
The National Medical Products Administration Issued a Correction Statement! “Deeply Apologetic”

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 ...
- Source: drugdu
- 358
- February 4, 2025
Will the National Biopharmaceutical Alliance’s Centralized Procurement Reshape the Biosimilar Market?

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. ...
- Source: drugdu
- 590
- February 3, 2025
The possibility of fraud is small, and it is recommended that generic drugs do a good job in the daily sampling inspection of consistency evaluation

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 ...
- Source: drugdu
- 330
- February 3, 2025
Novo Nordisk Surged by Over 10% at One Point as New Weight – loss Drug Amycretin’s Trial Data Shines

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 ...
- Source: drugdu
- 428
- February 3, 2025
Chengda Biotech’s Quadrivalent Influenza Vaccine Accepted by the Drug Administration

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 ...
- Source: drugdu
- 436
- February 3, 2025
A Global Breakthrough Battle for Chinese Innovative Drugs

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 ...
- Source: drugdu
- 1,188
- February 2, 2025
“ Hainan Haiyao Announces Estimated 2024 Net Profit Loss of 900 to 1,300 Million Yuan”

“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 ...
- Source: drugdu
- 335
- February 2, 2025
“Turning Ancient Classical Prescriptions into New Drugs, Shanghai’s First 3.1-Type New Chinese Medicine Approved for Marketing”

“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”, ...
- Source: drugdu
- 366
- February 2, 2025

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