China Pharmaceutical Promotion Association 2021-end inventory series three: ten keywords in the pharmaceutical industry

Time flies, 2021 has quietly ended
.

This year is the first year of China's 14th Five-Year Plan.

National centralized procurement

After several years of piloting and promotion, on January 28, 2021, the General Office of the State Council issued the "Opinions on Promoting the Normalization and Institutionalization of the Centralized Procurement of Drugs with Volume", which stipulated the scope and rules of procurement with volume
.

In 2021, China will conduct two centralized procurements

The national centralized procurement in 2021 has covered 218 drugs and high-value medical consumables that are most widely used clinically and have the highest sales in China, and is continuing to expand.
The normalization of centralized procurement in the future has also become an industry consensus
.

It took only three years from the 4+7 city pilot proposed in 2018 to today's national centralized procurement, and the scope of national volume procurement has expanded from medicines to medical devices

Centralized Procurement of Chinese Patent Medicine

In 2021, two large-scale inter-provincial alliances will conduct centralized procurement of proprietary Chinese medicines, namely the Hubei 19-province alliance and the Guangdong 6-province alliance
.

Previously, proprietary Chinese medicines have always been a difficult point in centralized procurement

At present, the centralized procurement of Chinese patent medicines in Hubei has been completed and has shown good results.
182 products from 157 companies have participated in the quotation, with a procurement scale of nearly 10 billion yuan
.

97 companies and 111 products were selected, with a selection rate of 62%.

Dynamic adjustment of medical insurance catalogue

The 2021 new version of the medical insurance catalogue was first issued on June 9, 2021, for comments on the adjustment plan.
The three-day negotiation started on November 9, and the official catalogue was released on December 3
.

Entering the new year, the 2021 new version of the medical insurance catalog has been officially implemented

From the perspective of negotiation, a total of 117 drugs were negotiated, and 94 were successfully negotiated, with an overall success rate of 80.
34%
.

Among them, 67 of 85 exclusive drugs outside the catalog were negotiated, with a success rate of 78.

Five-year plan for medical insurance

On September 29, 2021, the General Office of the State Council issued the "14th Five-Year Plan for National Medical Insurance" (hereinafter referred to as the "Plan")
.

This is China's first five-year plan for medical insurance, and it is clear that by 2025, the medical insurance system will be more mature and finalized

In addition, the "Plan" sets a "1+3" target system.
One overall goal is to reduce the proportion of personal health expenditure to total health expenditure to 27%.
During the "13th Five-Year Plan" period, this proportion has dropped from 29.
3% to 27.
7%
.
The decline of this indicator means that the burden of seeing a doctor for the common people will be further reduced
.

rare disease

With the gradual improvement of the national medical security system, more and more attention has been paid to the treatment and security of rare diseases
.
This year, the National Medical Insurance List was adjusted, and 7 kinds of drugs for rare diseases entered the new version of the National Medical Insurance Drug List through negotiation
.

Medication for patients with rare diseases has always been the focus of attention in the process of adjusting the national medical insurance drug list, and the world's first precision targeted therapy drug for the treatment of spinal muscular atrophy - Nosinagen Sodium Injection has finally achieved " "Shangxin", from 700,000 injections to more than 30,000, greatly reducing the burden on patients
.
At present, the number of rare disease drugs in the medical insurance list has reached 45, and a large number of rare disease patients in China have benefited from it
.

CAR-T

2021 can be called the first year of chimeric antigen receptor T cells (CAR-T) in China
.
In June 2021, the Achilles injection developed by Fosun Kite was approved by the National Medical Products Administration (NMPA), becoming the first CAR-T product to be marketed in China
.
After a lapse of two months, the new CAR-T product Ruiki Orenxai injection developed by WuXi Junuo has also been officially approved for marketing
.
At the end of the year, the CTA101 UCAR-T (universal CAR-T) cell injection product independently developed by Beiheng Biotechnology was accepted by CDE for a new drug clinical trial application
.

CAR-T technology is an emerging anti-tumor cellular immunotherapy
.
The treatment process is easier for patients to accept.
Under normal circumstances, CAR-T cell therapy only needs one administration, and it can recognize and kill tumor cells with high efficiency
.
Relevant data show that CAR-T therapy can significantly prolong the survival time of patients, and even cure some patients
.
In recent years, CAR-T therapy has become a high-profile innovative tumor therapy
.

PD-(L)1

In 2021, the domestic PD-(L)1 will usher in the approval peak
.
According to statistics, a total of 24 indications for PD-1/PD-(L)1 have been approved in China, exceeding the total number of approved indications in the three years from 2018 to 2020 (20)
.
Among them, the new indications of domestic PD-(L)1 monoclonal antibody have been approved and accelerated, reaching 17, which is a 2-fold increase compared to the number in 2020 (4), and 7 new indications of imported PD-(L)1 have been rolled over.
Approved indications
.
At the same time, domestic PD-(L)1 covers a wide range of tumor types, which is not inferior to K and O drugs with first-mover advantage
.
Domestic PD-(L)1 has been approved for indications covering non-small cell lung cancer (NSCLC), esophageal cancer (EC), liver cancer (HCC), nasopharyngeal cancer (NPC), MSI-H/dMMR solid tumors, and urothelial Cell carcinoma (UC), classic Hodgkin lymphoma (c-HL), malignant melanoma (MM)
.
Among them, lung cancer is the market with the largest number of PD-(L)-1 approved treatment indications, reaching 16 (including two SCLC treatment indications)
.

In 2022, it is expected that 3 domestic PD-1 and 1 PD-L1 monoclonal antibodies will be approved with 7 first-line treatment indications, and more patients will benefit by then
.

new crown vaccine

Since the new crown epidemic swept the world, vaccines have been given the hope of cracking the epidemic
.
China is one of the first countries to complete the development and launch of vaccines
.
In February 2021, the State Drug Administration successively approved the conditional listing of three vaccines
.
On February 5, Kexing Zhongwei's new crown inactivated vaccine Kerraff was approved for marketing, and it took only 3 days from the submission of the marketing application to the approval
.
Shortly thereafter, the new crown inactivated vaccine Zhongkang Kewei and CanSino's recombinant new crown vaccine Keweisha of the Wuhan Institute of Biological Products of China underwent emergency review and approval in accordance with the special drug approval procedures, and were approved for listing with conditions
.
It is worth noting that Keweisha has become the first approved new crown vaccine with adenovirus as a vector in China.
The protection rate after 28 days of single injection is 65.
28%, marking a breakthrough in another technical route other than inactivated vaccines
.

Vaccinations have been gradually promoted across the country, with two-shot vaccines being the mainstay in all regions, and free vaccinations for citizens
.
In the second half of this year, in order to consolidate the protective effect of the first two shots and prevent the new variant virus, China launched the third shot of the vaccine, and the "third shot" has once again become a focus topic
.

According to data released by the Joint Prevention and Control Mechanism of the State Council, as of December 2021, more than 2.
69 billion doses of COVID-19 vaccines have been vaccinated across the country, and more than 1.
19 billion people have been vaccinated, and the vaccination rate has reached more than 80%
.

Specific medication for novel coronavirus

The new coronavirus is constantly mutating.
In addition to vaccines, specific drugs against the virus are also the focus of research and development
.
On November 4, 2021, Merck & Co.
(MSD) and Ridgeback Biotherapeutics announced that the UK Medicines and Medical Products Regulatory Agency (MHRA) has authorized the use of the company's oral antiviral small molecule drug monupavir in the UK for the treatment of mild to Adult patients with COVID-19 who are moderate and have at least one indicator at risk of severe illness have become the world's first oral drug for COVID-19
.
In addition to Merck, on December 22, 2021, Pfizer's oral new crown drug "Paxlovid" has been approved for marketing, becoming the first officially authorized oral anti-new crown virus drug in the United States
.

In addition, good news has also been reported in the research and development of special drugs for the new crown in China
.
On December 8, 2021, the combination therapy of the novel coronavirus monoclonal neutralizing antibody ambavirumab/romisevirumab (previously known as the BRII-196/BRII-198 combination therapy) received emergency approval from the China Medical Products Administration.
, for the treatment of the new coronavirus
.
This is the first monoclonal antibody drug approved by the regulatory agency in China, and also the first fully self-developed anti-new coronavirus specific drug in China
.

License out

In 2021, whether overseas or in China, the number of license out transactions of Chinese pharmaceutical companies' rights and interests will increase, and many transaction volumes will set new historical records
.
According to statistics from Firestone, a total of 30 license out transactions occurred in domestic pharmaceutical companies, with a disclosed transaction amount of about US$13.
3 billion
.
Among them, BeiGene, Changrong Bio, Gaocheng Bio, Junshi Bio and other companies have more than 1 billion US dollars in transaction volume
.

In 2021, BeiGene's maximum license out transaction amount exceeded US$2.
9 billion, becoming the highest amount of domestic single-variety drug authorization cooperation in 2021
.
On December 20, 2021, BeiGene announced that it has reached a cooperation agreement with Novartis to license the rights and interests of TIGIT antibodies in the United States, Canada, many European countries and Japan to Novartis, with a total amount exceeding US$2.
9 billion
.
Previously, BeiGene reached a cooperation with Novartis on January 12, 2021 on the development, production and commercialization of its self-developed anti-PD-1 antibody drug tislelizumab in multiple countries.
Licensing agreements with a total transaction value of over $2.
2 billion
.

From the perspective of disease field distribution, the license out in 2021 is mainly concentrated in the fields of tumor, immunity, respiratory system, etc.
, and the tumor field accounts for the largest proportion
.
Among them, the largest transaction amount is the cooperation between Rongchang Bio and Seagen on Vidicitumab
.
On August 9, 2021, Rongchang Biotech and Seagen reached an exclusive global license agreement for the co-development and promotion of Vidicitumab.
Seagen will pay an upfront payment of US$200 million and milestone payments of up to US$2.
4 billion
.

2021 is a year for China's pharmaceutical innovation to continue the past and usher in the future.
In the frontier field of new drug research and development, domestic scientific research teams are constantly contributing Chinese strength to the world
.
At the same time, the construction of medical insurance is improving day by day, and more patients will benefit from it
.
Entering 2022, China's pharmaceutical innovation will continue to open a new chapter
.

References:

References:

1.
The ultimate inventory of pharmaceutical innovation in 2021: It is hard to imagine that we have experienced so much this year, Sina Pharmaceuticals

1.
The ultimate inventory of pharmaceutical innovation in 2021: It is hard to imagine that we have experienced so much this year, Sina Pharmaceuticals

2.
Centralized procurement of Chinese patent medicines: All these large varieties have been reduced in price.

2.
Centralized procurement of Chinese patent medicines: All these large varieties have been reduced in price.

3.
In 2021, the domestic PD-(L)1 will explode, and imported drugs will face extinction;

3.
In 2021, the domestic PD-(L)1 will explode, and imported drugs will face extinction;

4.
Press Conference on Joint Prevention and Control Mechanism of the State Council

4.
Press Conference on Joint Prevention and Control Mechanism of the State Council

5.
The new crown special drugs are competing for the market, can it bring a new turning point for the epidemic?

5.
The new crown special drugs are competing for the market, can it bring a new turning point for the epidemic?

6.
Crazy Idea: Arming CAR-T Cells to Become a "Micro Pharmacy" for Cancer Drugs; Bioworld

6.
Crazy Idea: Arming CAR-T Cells to Become a "Micro Pharmacy" for Cancer Drugs; Bioworld

7.
Top 10 Medical Insurance Hot Words in 2021, Lilac Medical Management

7.
Top 10 Medical Insurance Hot Words in 2021, Lilac Medical Management

8.
There is also a "spring" on a small scale, and the TOP list of license-out amounts in 2021 has changed; Yaozhi.
com

8.
There is also a "spring" on a small scale, and the TOP list of license-out amounts in 2021 has changed; Yaozhi.
com

9.
2021 Chinese innovative drug License out overseas inventory!

9.
2021 Chinese innovative drug License out overseas inventory!

10.
Annual inventory: Top 10 biomedical license out licenses in 2021; Firestone Creation

10.
Annual inventory: Top 10 biomedical license out licenses in 2021; Firestone Creation