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On September 15, the application for the listing of Yangtze River's Class 3 generic oseltamivir phosphate dry syrup was accepted by CDE
.
As a well-known domestic private enterprise, Yangtze River is also planning innovation and transformation.
The first class 1 new drug has been launched, and 15 innovative drugs are on the way
The first class 1 new drug has been launched, and 15 innovative drugs are on the wayAs a well-known domestic private enterprise, Yangzijiang regards R&D and innovation as the strategic basis for corporate development.
At present, the company has established a R&D team with a total of more than 1,600 people and more than 50% of masters and Ph.
Ds.
It is located in Beijing, Shanghai, Guangzhou, Nanjing, Chengdu and other places have established research and development centers for innovative medicines, traditional Chinese medicines and biological medicines
.
The innovative drugs independently developed by Yangtze River are mainly small-molecule chemical drugs, but the exploration of biological drugs is also gradually being carried out
.
Shengsen Bio is the company's new biopharmaceutical project in 2021, with an investment of 5 billion yuan.
In addition, Yangtze River has also accelerated the intensity and pace of introducing new products
.
In November 2020, the company established an exclusive strategic partnership with Changchun Anwo High-tech to promote the commercialization of 8 biosimilar drugs in China; in March 2021, the company reached a partnership with South Korea’s Daewong Pharmaceutical to obtain the PPI inhibitor Fexuprazan R&D, sales and supply rights; In May 2021, the company and Maiwei Biotechnology reached a strategic cooperation on the domestic rights and interests of two innovative biological drugs
With independent research and development + cooperative introduction, Yangtze River's innovative drugs are gradually entering the harvest period
.
On May 31, the company's first class 1 new drug, Levoornidazole Ester Disodium Phosphate for Injection, was approved for marketing.
According to data from Meinenet, there are currently 15 innovative drugs in Yangtze River (excluding the new indications for the development of new drugs on the market) that are in the clinical and above stage, 14 of which are Class 1 new drugs, covering anti-tumor, nervous system, digestive and metabolic systems, Therapeutic areas such as the muscular and skeletal system
.
Yangtze River is researching innovative drugs
Source: China Drug Clinical Trial Publicity Library of Meinenet
In the field of anti-tumor, 4 new class 1 drugs are undergoing phase I clinical trials.
YZJ-0673 is a pan-PI3K inhibitor.
No drug with the same target has been approved for marketing in China; YZJ-0318 belongs to the third-generation EGFR-TKI, which has been approved in China.
New domestic drugs such as Ametinib from Hausen and Vometinib from Iris were approved; MW11 is a PD-1 monoclonal antibody introduced by Yangtze River.
In 2020, the domestic PD-1 monoclonal antibody market has exceeded 10 billion yuan
.
In the field of nervous system, YZJ-1139 tablet is an orexin receptor OX1/OX2 dual antagonist, which can improve sleep by inhibiting orexin receptors.
It has completed phase II clinical trials; two new class 1 drugs YZJ-1495 hydrochloric acid Both salt capsules and YR-1702 injection can be used for pain, and both are currently undergoing phase I clinical trials
.
In the field of digestive and metabolic systems, Fexuprazan (non-surazan) is a new type of PPI inhibitor introduced by Yangtze River.
It is a potassium ion competitive acid blocker (P-CAB), which is compatible with traditional H+/K+-ATPase inhibitors.
(Such as omeprazole, pantoprazole, etc.
) Compared with omeprazole, it has the advantages of fast onset, long-lasting acid suppression effect, and stable plasma concentration
.
79 over-reviewed varieties are eye-catching, and 19 varieties sprint for the first time
79 over-reviewed varieties are eye-catching, and 19 varieties sprint for the first timeSince the formal launch of the generic drug consistency evaluation in 2016, Yangzijiang has organized a large number of manpower and material resources to carry out technical research, and rely on its own accumulated advantages of raw materials for many years to realize the integration of preparations and raw materials, giving the company an advantage in the national centralized procurement
.
According to data from Meinenet, there are currently 79 varieties in Yangtze River that have passed or deemed to have passed the consistency evaluation.
The number of over-evaluated varieties is second only to Qilu Pharmaceutical, and 61 of them have been included in the national centralized procurement
.
Based on the start date of the status, the number of Yangtze River reviewed varieties has been increasing year by year, with only 5 in 2018, 14 in 2019, 25 in 2020, and 35 so far in 2021
.
In terms of dosage form, Yangtze River’s reviewed varieties include injections, tablets and capsules and other oral regular-release preparations, eye drops, granules, chewable tablets, etc.
, of which 31 are injections, leading the injection review list
.
Yangtze River reviews
Note: With * is the first review, ** is the exclusive review
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
Among the 79 reviewed varieties, 22 were the first to be reviewed.
Among them, terazosin hydrochloride capsules, tamoxifen citrate tablets, mecobalamin injection, entecavir oral solution, epalrestat tablets, and Leprosy for injection Tetroxed, erdosteine capsules, ornidazole capsules are exclusive reviews
.
Since the launch of the national centralized procurement, Yangtze River has achieved a lot.
A total of 31 varieties have successfully won the bid, including 4+7 centralized procurement winning 2 bids, the second batch of centralized procurement winning 4, the third batch of centralized procurement winning 7 and the fourth batch 8 bids were won in centralized procurement, and 10 were won in the fifth batch of centralized procurement
.
Yangtze River has a low or zero market share in most of the winning bidders, and it can quickly increase the volume after the centralized procurement wins the bid
It is currently one of the main methods for domestic companies to over-evaluate the production of new classifications.
Among the generic drugs reported by Yangtze River's new classification, 76 varieties are still under review.
In 2020, China's public medical institutions will end The total sales scale exceeds 30 billion yuan
.
Yangtze River's new classification is reported for production and there is no first copy approved variety under review
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
No first imitation (including the first imitation of the dosage form) of 20 varieties in the domestic market has been approved for listing, including Bayer’s Regorafenib (2020 global sales of 475 million euros) and Merck’s sugammadex (2020 global sales of 11.
98) 100 million U.
S.
dollars), among which 13 varieties are produced by Yangtze River first or exclusively under the new classification
.
As the son inherits his father's career, where will Yangtze River go in the future?
As the son inherits his father's career, where will Yangtze River go in the future?On September 15, the listing application of Yangtze River's Class 3 generic oseltamivir phosphate dry syrup was accepted by the CDE.
This is the first product application dynamic since July 15
.
Yangzijiang, who has always been "active", suddenly had a "silence" for two months.
On July 12, Yangtze River’s official website issued a notice confirming that the company’s founder and chairman Xu Jingren died of illness at 20:39 on July 12 at the age of 77
.
After half a month (July 29), Yangzijiang Pharmaceutical announced that Xu Haoyu was elected as the company's chairman and legal representative, and at the same time as the company's general manager
.
The sudden death of Xu Jingren left a "commercial giant" with a scale of hundreds of billions.
The "silence" during this period of time may be due to the company's integration of resources and re-planning of its future development direction
.
What kind of Yangtze River will Xu Haoyu, who inherited his father's career, bring?
Before Xu Jing's life, he had the famous "three nos" principle, that is, not to engage in mergers and alliances, not to blindly go public, and not to do industries that he is not familiar with
.
From the early remarks, it can be seen that Xu Haoyu's management >
In an interview with the magazine in 2012, Xu Haoyu believed that “not going public has the benefits of not going public, but future listings and mergers and acquisitions are all necessary.
The current comparison is strength, thinking, and capital
.
” He also mentioned that Yangzijiang has always insisted on making medicine, but if it really wants to make the pharmaceutical industry stronger and bigger, it can also develop in the health field, including making medicine, making machinery, and making health care products
.
Under the implementation of a series of policies, China's pharmaceutical industry is facing reshuffle and reshaping.
Against this background, does Xu Haoyu still retain his earlier business philosophy? Will it open the way for joint mergers and acquisitions? What will the new era of Yangtze River look like? These are all worthy of attention, and Mi Nei.
com will continue to follow up
.
Source: Mynet database, official website of the State Drug Administration, etc.
Note: The statistics are as of September 13, if there are any omissions, please correct me!