On October 30
News list
01 Today's hot discussion
- more than new crown ! American experts warn "triple epidemic" storm this winter. (See the key details for details)
02 Economic market
- market has been expanding year by year! anti-ED drugs sold over 5.5 billion yuan. (see the key details for details)
- renfu Pharmaceutical announced on October 27 that achieved operating income of 5.653 billion yuan in the third quarter, and increased by 8.88% year-on-year; net profit was 683 million yuan, a year-on-year increase of 58.18%, and net profit of 2.277 billion yuan in the first three quarters, a year-on-year increase of 108.1%.
03 Illegal notification of
- plagiarism, fraud, academic misconduct , and many doctors were reported to be punished! (See the key details for details)
- Recently, the website of Jiamusi Municipal Commission for Discipline Inspection and Supervision released: Assistant manager of the Medical Devices Division (high value consumables) of Jiashitang Pharmaceutical Co., Ltd. is suspected of serious violations of duty, and is currently under supervision and investigation by the Tongjiang Municipal Supervision Commission.
- On October 28, the Jiangxi Provincial Drug Administration issued a suspension announcement. Content shows: Jiangxi Chuangrui Carbon Industry Co., Ltd. reported that it had stopped production of medicinal carbon due to the company's own reasons. The suspension period was from October 13, 2022 to April 12, 2023.
04 Industry attention
- centralized procurement black swans frequently appear: OK mirror leader fell 20% in a single day. (see the key details for details)
- Population aging is accelerating, and my country's artificial shoulder joint market has a lot of room for expansion. (See the key details for details)
05 Drug approval
- Hisco 1 new drugs have exploded, besieging more than 30 billion market. (see the key details for details)
- This antibiotic injection rose 88% , , Chengdu Bete won the first review. (See the key to read in detail)
- Recently, Sichuan Miaoji Bio/ Sichuan Meida Kangkale Pharmaceutical was accepted by CDE for the listing application for dihydroxypropyl theophylline injection submitted in the 3 generic class 3. This drug can be used for bronchial asthma , wheezing bronchitis, obstructive emphysema, etc. to relieve the symptoms of wheezing, and is also used for asthma caused by cardiogenic pulmonary edema.
06 Drug R&D
- On October 28, Fosun Pharmaceutical issued an announcement stating that its subsidiary Fuchuang Pharmaceutical recently received a notice that due to the adjustment of Eli Lilly's R&D pipeline strategy, Eli Lilly decided to terminate the existing development activities of the Bcl-2 inhibitor FCN-338 in the region (all countries and regions except mainland China, Hong Kong and Macao, the same below), and terminate the licensing cooperation as agreed.
Focus on reading
Hot discussion today
[Not just the new crown! American experts warn of the "triple epidemic" storm this winter] comprehensive report, American health experts warn that the new crown, influenza and respiratory syncytial virus (RSV) are currently spreading, and the United States may experience a "triple epidemic this winter."
According to ABC (ABC), the latest data from the Centers for Disease Control and Prevention (CDC) shows that compared with before, respiratory diseases occur earlier this year and more people are infected. There are also signs of early increase in flu activity in most parts of the United States, suggesting that this season may be more severe than the previous two seasons.
It is reported that as of the afternoon of the 24th, the occupancy rate of pediatric beds in the United States reached the highest level in two years, and an estimated 75% of the 40,000 beds were pediatric patients.
On the other hand, CDC data shows that although the new coronavirus infection in the United States has not yet begun to surge, in the past few years, the virus began to spread rapidly around Thanksgiving. experts said that the coronavirus has caused a decline in immunity and a lack of opportunities to be exposed to other viruses, coupled with the close gathering indoors, is fueling a "perfect storm."
Epidemiology at Boston Children's Hospital, John Brownstein, said: "Our hospitals are not only short of beds and insufficient key personnel, but the rising virus infection has caused a unfortunate perfect storm. This storm can be seen everywhere now."
experts said that according to CDC data, the positivity rate of influenza test has risen from 1.27% in the week ending September 24 to 4.38% in the week ending October 15, higher than the previous normal level.
According to the " New York Times ", there is currently no vaccine for RSV, which causes the deaths of about 14,000 adults aged 65 and above, and the deaths of 300 children under the age of 5 each year. Experts suggest that parents can consider getting their children to wear masks and make sure they develop good hygiene habits.
Economic market
[The market has been expanding for years! Anti-ED drugs have sold over 5.5 billion yuan] In recent years, affected by factors such as the accelerated pace of life, increased work pressure, and unhealthy living habits, the number of people suffering from erectile dysfunction (ED) has shown an upward trend and is developing towards youth. According to the National Health and Health Survey data, the prevalence of ED among men over 40 in my country is about 40%.
Currently oral phosphodiesterase (PDE5) inhibitors are still the preferred way to treat ED. The more popular drugs include sildenafil, tadalafil, vardenafil , etc.
3PDE5 inhibitors on the market in China
Source: Minnei.com New version database
Tadalafil tablets from more than 320 pharmaceutical companies Generic drugs and sildenafil citrate tablets from more than 10 pharmaceutical companies have been approved for marketing, and vardenafil hydrochloride tablets, avanafil tablets, sildenafil citrate oral collapse tablets, etc. have also successively ushered in the first generic companies; in terms of innovative drugs, the new preparation improved drug tadalafil oral membrane was approved in February 2022, and the first anti-ED domestic first-class new drug erdenafil citrate tablets was also approved for marketing at the end of 2021, bringing new options for medication for ED patients.
Retail pharmacies are the main way for ED patients to purchase medicine. m Inner Network data shows that in recent years, the sales of PDE5 inhibitors in China's retail pharmacies terminals (urban physical pharmacies + online pharmacies) have increased year by year, exceeding 5.5 billion yuan in 2021, a year-on-year increase of more than 30%.
In recent years, sales of China's retail pharmacies terminal PDE5 inhibitor
in recent years (unit: 10,000 yuan)
Source: Minnei.com Database
Illegal notification
[Plaintiff, fraud, academic misconduct, many doctors were reported and punished! 】On October 25, the National Natural Science Foundation of China announced the "Notice on the Handling Results of Misconduct Cases Investigated and Dealed in 2022 (Third Batch)", involving 39 physicians and project researchers from various medical universities.
Screenshot Source: NMPA official website
Violations include: forgery and tampering with research data, plagiarism in project application form, false signatures, tampering with pictures, etc. Among them, Shan Tao, deputy chief physician of general surgery at the Second Affiliated Hospital of Xi'an Jiaotong University (Northwest Hospital), was forged in the paper; Cai Yuanzhen, an arthrologist at Xi'an Red Society Hospital (Affiliated Red Society Hospital of Xi'an Jiaotong University Medical College, Shaanxi Provincial Orthopedic Hospital), was plagiarized; Zhang Guofeng, attending physician of the peripheral vascular department outpatient clinic of Xi'an Jiaotong University, was suspected of academic misconduct; Li Xiaoyan, chief physician of rheumatism and immunology at Shaanxi Provincial People's Hospital (Third Affiliated Hospital of Xi'an Jiaotong University Medical College), used other people's application forms, and Zhang Min, an employee of the Center for Disease Control and Prevention of Suzhou High-tech Zone (Huqiu District), was suspected of plagiarizing the content of other people's application forms.
industry attention
[Clustered black swans frequently appear: OK lens leader fell 20% in a single day] Hard breathable contact lens for corneal shaping, commonly known as "OK mirror". This product is suitable for the eyes to delay myopia and the growth of astigmatism number and , and is widely used in the prevention and control of myopia in adolescents.
On October 27, the Hebei Provincial Medical Drugs and Devices Procurement Center issued a notice that the province plans to carry out centralized procurement of 20 types of medical consumables in the near future and organize information filling work; what attracted the most attention was that the popular high-profit variety "hard breathable contact lens for corneal shaping" was included.
Subsequently, OK mirror concept stock collectively fell in the early trading. OK mirror leader Oppokvis opened sharply in the morning and then fell unilaterally until 20% hit the limit . Prie Ophthalmology and Aier Eye Hospital both fell by more than 10%, and concept stocks such as He's Ophthalmology and Aibo Medical also fell sharply; even driven by the sharp drop in OK lens concept stocks, the entire medical sector fell sharply.
Regarding the information filling notice released by Hebei Province, the relevant listed companies stated that the centralized procurement information needs to be further clarified. Some investors also believe that the price difference between the two is too large, which is an important reason for the high price of OK mirrors, so centralized procurement may not be a negative news.
[Population aging accelerates, my country's artificial shoulder joint market expansion space is large ] Recently, the Medical Device Technology Review Center of the State Food and Drug Administration issued the "Guiding Principles for the Registration Review of Artificial Shoulder Joint Prosthesis (Draft for Comments)" to solicit opinions from the public. Draft for soliciting opinions shows that the guiding principle aims to guide registered applicants to prepare and write registration application materials for artificial shoulder prosthesis, and also provides reference for the technical review department to review registration application materials.
"Guiding Principles for Registration Review of Artificial Shoulder Joint Prosthesis (Draft for Comments)" points out that according to the " Medical Device Classification Directory ", artificial shoulder joints belong to the third category of medical devices and are classified as orthopedic implanted medical devices. Data released by m Inner Network and other institutions show that by 2024, the market size of orthopedic implantable medical devices in my country is expected to reach 60.7 billion yuan, with an average annual compound growth rate from 2019 to 2024 to be about 14.51%.
Artificial joint implantation medical devices are one of the fastest-growing orthopedic implantation medical devices segments in the market. Research reports from Mine.com and other institutions show that from 2015 to 2019, the market size of my country's artificial joint implantable medical devices has increased from 4 billion yuan in 2015 to 8.6 billion yuan in 2019, with an average annual compound growth rate of 20.65%. It is estimated that by 2024, the market size will reach 18.7 billion yuan (see the figure for details). As an important branch of the artificial joint implantation device market, artificial shoulder joints are also expected to further develop with a faster growth rate.
In addition, in recent years, my country's population aging has intensified and medical demand has continued to increase, which has to a certain extent prompted the market size of my country's orthopedic implantable medical devices to show a rapid growth trend. Data from the National Bureau of Statistics shows that from 2015 to 2020, the number of people aged 60 and above in my country has increased from 231 million to 267 million, and the proportion of the total population has increased from 16.70% to 18.90%. It can be foreseen that with the increase in the number of elderly people in my country, the market demand for orthopedic implantable medical devices such as artificial shoulder joints will be further released.
Drug approval
[Hisco Class 1 new drug outbreak, besieging more than 30 billion markets] On October 27, Hiisco submitted its HSK16149 capsules for the marketing application submitted by the new drug Class 1 was accepted by the CDE. Based on clinical progress, it is speculated to be used to treat diabetic peripheral neuralgia.
(Source: CDE official website)
HSK16149 is a new type of analgesic of voltage-gated calcium ion channel. It is a me-better drug of pregabalin . It has the characteristics of high target selectivity, strong analgesia, long-acting analgesia, and small central side effects. It may be better for moderate to severe patients.
In addition to the indications of peripheral neuralgia in diabetes, HSK16149 also has indications such as postherpetic neuralgia and peripheral neuralgia in phase III clinical practice.
Source: HSK16149 Capsules Clinical Development in Part
Source: HSK16149 Capsules Clinical Development in Part
MNNNN New Version Database
Anesthesia and analgesia is the treatment area that HiSK16149 Capsules is focused on. m Intranet data shows that in 2021, the total sales scale of terminal anesthetics and painkillers in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions) exceeded 30 billion yuan.
[This antibiotic injection has surged by 88%, and Chengdu Bete won the first review] On October 28, NMPA released a new batch of drug approval certificate documents to be received. Among them, Chengdu Bete Pharmaceutical 's Amikaxing Sulfate Injection passed the consistency evaluation and was the first passed review pharmaceutical company in this variety. So far, this year, 17 varieties (27 product specifications) of Bet Pharmaceutical have passed/deemed to pass the consistency evaluation.
screenshot source: NMPA official website
Amikacin is an aminoglycoside antibiotic , which is the 2018 edition of National Basic Medicines Directory variety. It is a semi-synthetic aminoglycoside antibiotic, has obvious bactericidal effect, and is a quiescent bactericidal drug. Akamixing has many varieties in China, including lotions, injections, eye drops, etc., among which Akamixing Sulfate Injection is the main sales variety. According to statistics, the hospital sales of Amikaxing Sulfate Injection in the first half of 2022 increased by 88% year-on-year, and annual sales are expected to exceed the 100 million yuan mark.
Amikaxing Sulfate Injection Hospital Sales
In addition to the first approved Bet Pharmaceutical, this time, China Resources Shuanghe, Qilu Pharmaceutical and Xinxiang Changle Pharmaceutical also submitted supplementary applications for consistency evaluation of Amikaxing Sulfate Injection, which is still under review and approval.
So far, Bet Pharmaceutical has passed the consistency evaluation this year (27 product specifications) and passed the consistency evaluation. Among them, 8 varieties, including Amikacin sulfate injection, iopromide injection, cefuroximethate dry suspension, digoxin tablets, voriconazole for injection, albutamol sulfate injection, dexamethasone sodium phosphate injection and calcium gluconate injection, are the first to pass the evaluation.
2022 Beite Pharmaceutical's approved variety (Biaohong is the first to review)
Picture source: Yaorongyun
Health knowledge
Long-term drinking tea can help human health and talk about the risk of certain diseases. Middle-aged and elderly people should drink more tea in moderation.
- Director of the Clinical Nutrition Department of Peking Union Medical College Hospital Yu Kang
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