Out to sea tide
In fact, the tide of going to sea has been on the list of annual keywords for several consecutive years. According to incomplete statistics, in 2023, there will be nearly 80 innovative drug license out transactions in China, with a total disclosed transaction amount of more than US$35 billion, of which the down payment has reached US$4.6 billion.
Compared with previous years, the types of projects of domestic pharmaceutical companies going overseas are also more abundant, covering popular drug types such as monoclonal antibodies, bispecific antibodies, ADCs and CAR-T. **Areas include tumors, autoimmunity, blood diseases, cardiometabolic diseases, etc.
In terms of specific drug types, ADC is the most enthusiastic about trading. With the official approval of the "magic bullet" DS-8201 (trastuzumab) in China on February 24, the discussion of ADC has been high at the beginning of 2023, and the heat of the entire track continues to heat up, and the number of overseas trips this year is nearly 20. It is worth mentioning that the last licence-out of the year was closed by ADC.
On December 20, Hansoh Pharmaceuticals and GSK jointly announced that the two parties have reached an exclusive license agreement for HS-20093, a new ADC drug independently developed by Hansoh Pharmaceuticals, with a total transaction value of more than US$1.7 billion. This is the second ADC licensing deal between Hansoh Pharmaceuticals and GSK after October.
GLP-1 exploded
This year, the popularity of GLP-1** drug is "unattainable".
In March, Musk, the world's richest man in the technology giant, blew himself up on the social ** platform to inject the GLP-1 receptor agonist semaglutide (Wegovy), making it quickly popular "out of the circle". Musk has said that he has lost a total of 30 pounds (about 27.) with the help of Wegovy2 pounds).
In November, semaglutide's number one competitor, tirpatide from Eli Lilly, was officially approved for weight loss indications. The two officially kicked off the fierce market competition.
At the same time, domestic companies such as Huadong Medicine and Innovent Biologics have also begun to deploy GLP-1 receptor agonist pipelines, and most of them have been advanced to the clinical trial stage.
Domestic GLP-1 innovative drugs have shown excellent clinical efficacy in the fields of hypoglycemia and obesity, for exampleA small molecule of East China Medicine, TTP273, is comparable to semaglutide tablets。Especially in the field of **, domestic drugs have been produced to refresh the weight loss efficacy record of GLP-1R GCGR dual-target agonist.
The reason why domestic pharmaceutical companies are scrambling to be the first is because GLP-1 receptor agonists represented by semaglutide have been given huge imagination space by the market in the fields of hypoglycemic and weight loss.
Medicare negotiations
On November 20, the four-day on-site negotiation and bidding session for the adjustment of the 2023 National Medical Insurance Drug List was completedThis is also the largest number of varieties negotiated in the adjustment of the medical insurance drug list over the years since the establishment of the National Health Insurance Administration in 2018.
A total of 168 drugs were negotiated and tendered this year, including 148 exclusive drug negotiations and 20 non-exclusive drug bids. A number of new drugs, including domestic innovative drugs, have been successfully negotiated, covering oncology, chronic diseases, rare diseases and other fields.
On December 13, the results of the medical insurance negotiations were announced. A total of 126 new drugs have been added to the national medical insurance drug catalogue, and the average price reduction has been reduced by 61 through medical insurance negotiations7%。
The medical insurance negotiation policy continues to favor innovative drugs. This year, a total of 25 innovative drugs participated in the negotiations, and 23 were negotiated. Compared with the overall situation, the success rate of innovative drug negotiation is higher and the average decline rate is lower. In terms of contract renewal, the policy has also given price stabilization expectations, and 70% of innovative drugs have been renewed at the original price.
After this adjustment, the total number of drugs in the catalogue will increase to 3,088, including 1,698 Western medicines and 1,390 Chinese patent medicines, and the level of protection in the fields of chronic diseases, rare diseases, and children's drugs will be further improved.
Pharmaceutical companies cut jobs
In 2023, the capital chill has continued, and the chill is reflected in the fact that many companies have chosen to adopt personnel and pipeline streamlining plans to tide over the difficulties.
According to industry **fierce biotech statistics, as of December 17,At least 189 pharmaceutical companies have announced their personnel and pipeline streamlining or plans this year, reaching 15 times
Among them, nearly 20 pharmaceutical companies have announced multiple rounds of layoffs within a year, including large MNCs such as Pfizer, Johnson & Johnson, Biogen, and BMS, as well as many small and medium-sized biotechs.
Among them, the most concerned company for layoffs is undoubtedly the king of revenue in 2022 - Pfizer.
According to statistics, Pfizer has carried out 7 rounds of layoffs worldwide this year, with more than 2,000 layoffs.
Genes**
According to the statistics of Pharmaceutical Intelligence data, 5 genes** have been approved by the FDA for the first time this year, and the approval of these ** is of great significance.
In May, Krystal Biotech's gene Vyjuvek was approved by the FDA for the treatment of dystrophic epidermolysis bullosa, becoming the first FDA-approved gene for topical use and the first gene that can be redosed. In June, the gene **ELEVIDS jointly developed by SAREPTA Therapeutics and Roche received accelerated approval from the FDA, becoming the first one-time gene for patients aged 4-5 years with Duchenne muscular dystrophy (DMD). Also in June, Biomarin Pharmaceutical's gene Roct Ian was approved by the FDA, becoming the first FDA to approve the gene for patients with severe hemophilia A.
On December 8, the FDA approved both the CRISPR Therapeutics Vertex gene Casgevy and the Bluebird Bio gene Lyfgenia for marketing. The two approved genes** are for the same indication, sickle cell disease (SCD). This means that gene editing and lentiviral hematopoietic stem cell technology go hand in hand, and they are milestones in two major fields, respectively.
With more and more gene ** on the market, as well as the rapid development of gene ** technology, this field may usher in a period of rapid development. The U.S. FDA has said that it expects that by 2025, there may be 10 to 20 cells and genes approved each year**, which is expected to benefit more patients with rare diseases.
Oseltamivir is out of stock
From February to March this year, "influenza A" and norovirus infections entered the peak season. According to the surveillance data of the National Influenza Center, in the seventh week of 2023 (February 13-19), the positive rate of influenza virus tests in southern and northern provinces continued to rise.
Influenza A" attacked, and oseltamivir, known as the "miracle drug" of influenza, was once again pushed to the wind, and there was a situation of hot sales and even shortages and out of stock. According to the e-commerce platform, the price of 15mg*10 bags of oseltamivir phosphate granules is 60 yuan, the monthly sales volume is 60,000+, and the sales volume of another specification also reaches 10,000+;The price of 75mg*6 capsules of oseltamivir phosphate capsules is 85 yuan, and the monthly sales are 10,000+;Oseltamivir phosphate dry suspension** is 109 yuan bottle, with sales volume of 2000+.
Behind the "drug grabbing", there are various reasons. Some are in short supply due to the blowout of demand, some are haunted by the idea of "hoarding" due to fear and anxiety about the "virus", and some are raging because of rumors, which stir people's tense nerves. Either way, it boils down to people's anxiety about the supply of medical supplies when a major event occurs.
In fact, most patients who are infected with influenza are mild cases.
Jiang Rongmeng, vice president of Beijing Ditan Hospital affiliated to Capital Medical University and chief physician of the Clinical Center for Infectious Diseases, pointed out that viral infection actually follows a law, that is, the "iceberg phenomenon", and relatively few people become ill after infection, and only a few people become seriously ill after the onset of infection.
Jiang Rongmeng also said that this applies to most viral infections, especially after a period of epidemic, which is a general rule, so there is no need for the public to be overly anxious.
Medical anti-corruption
Starting from the second half of this year, ten ministries and commissions will carry out a one-year centralized governance of anti-corruption issues in the national pharmaceutical field, and carry out systematic governance work covering the whole field and the whole chain for key links such as production, sales, use, and reimbursement. The pharmaceutical field is an area with a high incidence of corruption, with a high degree of social concern, which is closely related to the vital interests of the people, and is a pain point that has been criticized by the people for a long time.
And since the launch of the anti-corruption campaign in the medical sector, there have been dry and dry members of the medical system almost every day. In the medical field, the intensity and breadth of such anti-corruption efforts are unprecedented.
The disclosure of a case by the Commission for Discipline Inspection and the State Supervision Commission this year can provide a glimpse into the seriousness of corruption in the medical system. A medical device linear accelerator with an import price of 15 million yuan, a hospital with 35.2 million yuan**, the rebate in the middle was eaten by the person in charge of the hospital 16 million yuan. The rebate is even higher than the device's!
This medical anti-corruption action has sounded the alarm for medical enterprises, and it is the right way for the development of enterprises to do a good job in R&D and innovation, not to think crookedly, and to win by product quality and service quality.
Mycoplasma infection
In October, in late autumn and early winter, a wave of mycoplasma infection disrupted the rhythm of many people's lives. Therefore, 2023 was once called the "big year of mycoplasma infection".
According to news reports, the number of cases of Mycoplasma pneumoniae infection in the outpatient clinics of children's hospitals in Beijing, Shanghai, Guangzhou and other places continues to increase, many children have developed fever symptoms, and many classes have even been suspended. At the same time, azithromycin topped the hot search, and there were even rumors that the azithromycin drug was out of stock. In March this year, there was just a wave of oseltamivir out of stock, and the drug shortage drama caused by large-scale infection was staged again.
Domestic azithromycin does not show a dominant situation. Sunflower Pharmaceutical, Dajia Weikang, Huluwa, Asia-Pacific Pharmaceutical, Luoxin Pharmaceutical and many other listed companies have been asked by investors about the situation of "azithromycin, a Mycoplasma pneumoniae-related product". Many companies have responded that azithromycin is in normal production and sales and can meet market demand.
In fact, azithromycin is a commonly used reserve drug, and the idea of consumers alone is not enough to cut off the supply of azithromycin. Experts revealed that at present, in the market, the sales of more than 100 generic drugs around the world have been "tied" with Pfizer's original drug.
Nuclear medicine
On February 5, Grand Pharma, which started nuclear drug research and development earlier in China, announced that its new drug application for TLX101, a global innovative radionuclide conjugate (RDC) for glioblastoma multiforme, was officially accepted by the NMPA. At the beginning of March, Hexin Pharmaceutical announced the completion of a round of financing of over 100 million yuan.
Two related news have opened a new round of R&D and financing "progress bar" for nuclear drugs in 2023.
Internationally, in March, Novartis and Bicycle Therapeutics reached a cooperation of more than $1.7 billion to develop bicycline-based RDCIn April, Novartis entered into a partnership of more than $400 million with 3B Pharmacuticals, which focuses on cancer radioactivity**In May, Bayer announced a $1.7 billion collaboration with Bicycle to develop bicyclic peptide RDC ...... for several undisclosed oncology targets
The increase in large-value transactions by international giants has made the popularity of RDC drugs continue to be in the first half of the year. In the second half of the year, on August 22, neighboring Japan announced that it would discharge "nuclear wastewater" into the sea. For a time, nuclear drugs were again exposed to the spotlight.
On August 28, Lisheng Pharmaceutical, an A-share listed company that produces potassium iodide APIs for nuclear radiation, rose 714%, which is also the Xilong scientific daily limit of the API potassium iodide ** business.
Whether it is the vast blue ocean market created by its own precision anti-tumor efficacy, or the passive market demand brought about by the turbulent international environment, nuclear drugs have become the trendsetters in the innovative drug market in 2023, and the development momentum is unabated.
According to BBC Research data, the global nuclear drug market size in 2020 was about 9.3 billion US dollars, of which diagnostic drugs accounted for the main market, with a scale of more than 7.7 billion US dollars, accounting for 834%, in the future, with the successive listing of first-class nuclear drugs, the global nuclear drug market is expected to grow at a compound growth rate of 116%, and the market size will reach $17.5 billion by 2026.
The "King of Medicine" changed hands
In 2022,Humira from AbbVie continued to defend its eleven-year reign as the king of medicine, with a record of 212The record of $3.7 billion is unrivaled.
As its patents expired one after another, it was challenged by the "top" of biosimilars at the beginning of this year, and sales also declined.
The old goes, the new comes. After Humira fell off the altar, K medicine launched a fierce offensive and stared at it. In the first three quarters of this year, K Pharmaceutical achieved a proud result of 18.4 billion US dollars, taking over the crown of drug king from Humira.
But the king of medicine's chair k medicine is not very stable. According to the latest financial report for the third quarter released by Novo Nordisk, semaglutide created 145 in the first three quarters of this year$5.8 billion in revenue, close to K drug.
The market consensus is that the battle for the king of drugs in 2023 will be between K drug and semaglutide.
Reference: Weekend Talk丨Medical anti-corruption is not just a storm;CCTV.
Oseltamivir "How to eat?".Hoarding or not hoarding?Read the article;CCTV.
Inventory of the success or failure of innovative drugs going overseas in 2023: the top 20 blocked and successful down payments;Realistic Pharmaceutical Society.
Article**: Yaozhi Headlines, Author in Water.
Kim Hyundai is a leading digital solution provider in China. In the field of biomedicine, with the vision of helping biopharmaceutical enterprises complete digital transformation, we have created digital solutions covering the whole link of R&D, quality, production and warehousing under the guidance of GMP standards, helping enterprises fully implement GMP standards. Yiming (Suzhou) Cell Bio is a company we serve located in Suzhou Biomedical Park. We helped Yiming complete the digital transformation, realized the full-chain digital management under the GMP standard, transferred offline business to online, and carried out cross-departmental centralized and unified management. It effectively guarantees the compliance of enterprises, and uses AI information recognition, Internet of Things and other technologies to improve the work efficiency of production, laboratory and other departments. In recent years, the biopharmaceutical market is facing an urgent need for industrial transformation, and the most important industrial driving force comes from two points: the application and empowerment of innovative technologies, and the exploration and breakthrough in the field of innovative research and development. Jin Hyundai has always adhered to the principle of "innovation is the primary productive force", and has continued to invest heavily in technology, talents, products and services. In the future, we will keep pace with the times, closely serve the national strategy, promote the digital upgrading of Chinese biopharmaceutical enterprises, and help Chinese biopharmaceutical enterprises take off. Based on the cost reduction, efficiency increase and GMP compliance needs of biopharmaceutical enterprises, Jin Hyundai has created a one-stop information solution covering the whole link of R&D, production, quality and logistics of biopharmaceutical enterprises, which has been successfully applied in the leading enterprise "Yiming Cell" in the biopharmaceutical industry, helping enterprises solve the pain points of strict regulatory policy requirements, difficult manual record traceability, and low effective use of data, and build a standardized, efficient and intelligent digital factory. 