PharmaFocus Today – Page 75 – media

From being crowded to being deserted, why has the business of consistency evaluation of generic drugs “cooled down”?

Recently, discussions about generic drugs and original research drugs have been heated, and the appearance of identical data in consistency evaluation has become the first “oolong” in the pharmaceutical industry in 2025. However, in the public opinion field, the voices of pharmaceutical companies and CRO (pharmaceutical research and development outsourcing) companies are almost inaudible. Even a CRO company told the reporter of “Daily Economic News” that “there has been no generic drug (consistency) test in the past five or six years.” This was hard to imagine eight years ago. In March 2016, the “Opinions of the General Office of the State Council on Conducting Consistency Evaluation of Generic Drug Quality and Efficacy” kicked off the domestic consistency evaluation of generic drugs. Pharmaceutical companies are willing to spend millions of yuan on consistency evaluation, and CRO companies are also very busy. The business of consistency evaluation of generic drugs by CRO ...
- Source: drugdu
- 203
- February 5, 2025
PD-(L)1 “rolls” into the second half and new drugs are launched. What is Kelun Botai selling?

On January 20, Kelun Pharmaceutical (SZ002422, stock price 28.13 yuan, market value 45.05 billion yuan) announced that its subsidiary Kelun Botai’s anti-PD-L1 tagolizumab (trade name: Kotel) was approved for combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). This is the second indication approved for tagolizumab. At the end of December 2024, the China National Medical Products Administration (NMPA) has approved tagolizumab monotherapy for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma who have failed 2 or more lines of chemotherapy for listing in China. It is worth noting that both among the 20 PD-(L)1 drugs that have been launched in China and in the indication of nasopharyngeal carcinoma, tagolizumab is “late to the party”. As a PD-L1 introduced from Kangfang Bio in 2014, why did Kelun Biotech still launch it to the market despite being “late to the ...
- Source: drugdu
- 198
- February 5, 2025
Editing errors caused

In response to the duplication of data on consistency evaluation of some generic drugs reported by the media, on January 24, 2025, the Data Management Office of the Drug Evaluation Center of the National Medical Products Administration issued a “Correction Statement” stating that it was caused by editing errors and has been corrected. Earlier, according to the First Financial News, there was news online recently that the similarity of multiple bioavailability data of the consistency evaluation of generic drugs by the National Medical Products Administration has aroused concern. The reporter checked the website of the Drug Evaluation Center of the National Medical Products Administration and found that there were indeed two generic drugs with exactly the same bioequivalence data when searching for “Rosuvastatin Calcium Tablets” and “Trimetazidine Hydrochloride Tablets”. The “Correction Note” stated that recently, the center received reports from relevant media and companies that there were duplicate data on ...
- Source: drugdu
- 208
- February 5, 2025
Core product sales are gratifying, and innovative drug companies are gradually entering the harvest period

Benefiting from the gradual recovery of industry prosperity, the continuous development of overseas markets, and the implementation of favorable pharmaceutical policies, A-share biopharmaceutical companies will continue to write innovative transcripts in 2024 in the process of resilient development. Choice data shows that as of January 25, more than 200 A-share biopharmaceutical companies have released their 2024 performance forecasts. From the lower limit of the forecast net profit growth, a total of 108 companies are expected to make profits, of which 18 companies expect their net profits to double (excluding loss-making and loss-reducing). In addition, 18 companies including Baili Tianheng, Hisun Pharmaceutical, Sinovac Pharmaceuticals, and Sinocell are expected to turn losses into profits, and 29 companies including Changshan Pharmaceuticals and Novozymes have also achieved year-on-year loss reduction. Sales volume drives performance growth Specifically, among the pharmaceutical companies that have released performance forecasts, 40 are expected to achieve year-on-year growth in net ...
- Source: drugdu
- 198
- February 5, 2025
Tianyu Pharmaceutical’s Avatrombopag Maleate Bulk Drug Substance Passes CDE Review

On January 27, it was reported that Tianyu Pharmaceutical (300702) announced that its avatrombopag maleate bulk drug substance has recently passed the review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This bulk drug substance belongs to chemical drug category 4, with the registration number Y20230000333, and the review result, jointly evaluated with the preparation, is A. The company submitted the registration application for avatrombopag maleate bulk drug substance to CDE in June 2023 and was accepted. Although this bulk drug substance has passed the CDE review, it still needs to obtain a “meeting requirements” result from the GMP compliance inspection by the Zhejiang Provincial Medical Products Administration before it can be launched and sold in China. Currently, 14 manufacturers in China have passed the CDE technical review. The company is preparing to apply for the GMP compliance inspection, and the time for market launch ...
- Source: drugdu
- 128
- February 4, 2025
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
- 164
- 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
- 214
- 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
- 218
- 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
- 345
- 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
- 217
- February 3, 2025

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