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 Last Update: 2022-06-03
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Introduction: According to the official website of the China National Medical Products Administration (NMPA), in 2021, China has approved about 60 new drugs (excluding new indications, improved new drugs, biosimilar drugs, traditional Chinese medicines and vaccines), creating nearly 5 24 of them are the world's first new drugs

Introduction: 24 products are the first batch of new drugs in the world

Among the 60 new drugs, there are 26 domestic drugs, accounting for 43%; 34 imported drugs, accounting for 57%; according to the types of new drugs, there are 39 small molecule new drugs, accounting for 65%; 21 new biological drugs , accounting for 35%; according to the indications, there are 26 new anti-tumor drugs, accounting for 43%, and non-tumor new drugs accounting for 57%

24 of the world's first batch of new drugs (excluding vaccines and traditional Chinese medicines) will be approved by the "official announcement" in 2021, compared with 14 in 2020 and 16 in 2019, setting a record high in the past three years

Table 1 24 first batch of new drugs in the world in 2021

Source of information: [1]Tabulation: Bio-Exploration Editorial Team

However, the high light of research and development does not mean the success of commercialization.

The research and development of innovative drugs is entering an embarrassing situation.

Alice Medicine

Drug: fumetinib mesylate tablets

2021 sales: 236 million

Highlights: Helping the company's revenue soar 944 times!

On March 3, 2021, Aeris Pharma's class 1 new drug, the third-generation EGFR inhibitor fumetinib, was approved for marketing, becoming the second domestically-approved third-generation EGFR inhibitor, which can be used to treat localized EGFR T790M mutation-positive patients.

The company achieved an operating income of 530 million yuan, a year-on-year increase of 94,407.

Rongchang Biology

Drugs: Taitacept

Drugs: Taitacept Drugs:

2021 sales: 47.

Drugs: Vidicitumab Drugs:

2021 sales: 84 million yuan

Highlights: Two innovative drugs contributed to a substantial increase in revenue

On March 29, Rongchang Bio announced its 2021 financial report.

The substantial increase in revenue was mainly contributed by the first profit of the company's products on the market.

Fosun Kate

Drugs: Achilles injection

Drugs: Achilles Injection Drugs:

Highlights: The price of 1.

The market retail price of this drug is 1.

Roche Pharmaceuticals: Risprom Oral Solution Powder

Roche Drugs: Risprom Oral Solution Powder Drugs:

2021 sales (global): $659 million

Highlights: As the only second choice for SMA treatment drugs, Biogen has been promoted to reduce the price of insurance

Risporan Powder for Oral Solution (hereinafter referred to as "Risperan") was jointly developed by PTC Therapeutics, the SMA Foundation and Roche for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older

As a rare disease drug, the market performance of risprom is very good.

Corning Jereh/Side Pharmaceuticals/Sincere Pharmaceuticals

Drug: Envolizumab

Drugs: Envolimumab Drugs:

2021 sales: 4.
4 million yuan

Highlights: Possessing differentiated advantages, deploying multiple high-incidence tumor types in China

On November 25, 2021, the PD-L1 subcutaneous injection inhibitor envolimab, a subsidiary of Corning Jereh, was approved for marketing
.
Envolizumab is the world's only subcutaneously administered PD-L1 single-domain antibody drug under the strategic cooperation between Simcere, Sydia and Corning Jereh.
It is also the first PD-L1 antibody originally developed in China.
Approved for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors
.
Envolizumab 200mg/support is priced at 5,980 yuan, subcutaneously administered once a week, 4 doses per course of treatment, and the drug cost per course of treatment is 23,920 yuan; on December 8, 2021, the first batch of envolimumab prescriptions landed
.
According to the company's financial report, as of December 31, 2021, the company had achieved sales revenue of 146 million yuan, of which envolimab achieved sales revenue of 4.
4 million yuan in just over 20 days
.
At present, tumor immunotherapy has become one of the mainstream drugs in clinical tumor treatment programs, and many products have been launched at home and abroad, but patients still have significant unmet clinical needs and are full of desire for better clinical drugs
.
Innovative molecular design enables Nvolumab to have differentiated advantages in terms of efficacy, safety, convenience, and compliance
.
In addition to the listed indications, Nvidia has also deployed in a number of high-incidence tumor types in China, including lung cancer, cholangiocarcinoma, hepatocellular carcinoma, colorectal cancer, gynecological tumors, and pan-tumor tumors with unmet clinical needs Corresponding clinical studies have been carried out in the field
.

As of December 31, 2021, the company achieved sales revenue of 146 million yuan, of which envolimab achieved sales revenue of 4.
4 million yuan in just over 20 days

Tengsheng Boyao

Drugs: Ambavirumab combined with romisevirumab

Drugs: Ambavirumab combined with romisevirumab Drugs:

Highlights: China's first special drug for new crown treatment

On December 8, 2021, the combination therapy of the novel coronavirus monoclonal neutralizing antibody ambavirumab combined with romisevirumab was approved by the NMPA for the treatment of mild and common types with progression to severe (including hospitalization or death) ) adults and adolescents (12-17 years old, weight ≥40kg) with high risk factors for the new crown patients
.
The drug was developed by Professor Zhang Linqi, a professor at Tsinghua University School of Medicine and director of the Center for Global Health and Infectious Disease Research and AIDS Comprehensive Research Center at Tsinghua University
.
Zhang Linqi said that the special drug can provide treatment and prevention effects, and one injection can last for 9 months or even 1 year
.

China has the first fully self-developed anti-coronavirus specific drug

BeiGene

Drugs: Pamidalide Capsules

Medicines: Pamidalide Capsules Medicines:

Highlights: China's original research into a new class of drugs PARP inhibitors

On May 7, 2021, according to NMPA's official website, BeiGene's product Pamiparib Capsules (product name: Baihuize®) was approved by NMPA for marketing for patients with germline BRCA mutations who have previously undergone second-line or above chemotherapy.
For the treatment of patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer, Baihuize® focuses on the treatment of platinum-sensitive and platinum-resistant recurrent ovarian cancer, as the only known non-drug pump ( P-gp) substrate PARP inhibitors, low resistance brings potentially longer progression-free survival and delays relapse
.
Baihuize® will be included in the National Medical Insurance List in 2021 and will be officially implemented at the beginning of this year
.
After entering the medical insurance, the price of Baihuize® decreased from RMB 7,000 per box (60 capsules, 20mg) to RMB 3,216, a drop of 54%
.
On February 25, 2022, the company announced its 2021 annual results.
The total operating income in 2021 was 7.
589 billion yuan, an increase of 257.
9% compared with the same period of the previous year
.

After entering the medical insurance, the price of Baihuize® decreased from RMB 7,000 per box (60 capsules, 20mg) to RMB 3,216, a decrease of 54%.

Hansen Pharmaceuticals

Drugs: Amitofovir tablets

Drugs: Amitofovir Tablets Drugs:

Highlights: The first Chinese original oral anti-HBV innovative drug

On June 23, 2021, the first Chinese original oral anti-hepatitis B virus innovative drug developed by Hansoh Pharma was also approved for marketing, for the treatment of adult patients with chronic hepatitis B.
It was approved by the end of 2021.
Included in the National Medical Insurance Catalog
.
In April 2022, Hansoh Pharmaceutical released its 2021 annual report.
During the reporting period, the company achieved revenue of 9.
935 billion yuan, a year-on-year increase of 14.
33%; the company's innovative drug sales revenue was 4.
202 billion yuan, a year-on-year increase of 168.
9%, accounting for 42.
3% of operating income ; the company's research and development The investment was 1.
797 billion yuan, a year-on-year increase of 43.
5%, accounting for 18.
1% of operating income
.
In terms of tumor business, revenue in 2021 will reach 5.
481 billion yuan, an increase of nearly 1.
5 billion yuan over the previous year, accounting for more than 55% of total revenue
.
A total of more than 25 innovative drugs of Hansoh Pharma have entered the clinical stage and are about to enter the intensive harvest period
.
Among them, 5 innovative drugs are in Phase II or above clinical stage, including pemosatide, which is expected to be the first domestic long-acting EPO drug, which has been reported for production
.

Hansoh Pharma released its 2021 annual report.
During the reporting period, the company achieved revenue of 9.
935 billion yuan, a year-on-year increase of 14.
33%; the company's innovative drug sales revenue was 4.
202 billion yuan, a year-on-year increase of 168.
9%, accounting for 42.
3% of operating income

Alliance Pharmaceuticals

Drugs: Contezolid Tablets

Drugs: Contezolid Tablets Drugs:

Highlights: The only new drug against drug-resistant bacteria with a new chemical structure in the new catalog

On June 1, 2021, Contezolid tablets were officially approved by the National Medical Products Administration (NMPA) for the treatment of complex skin and soft tissue infections, becoming the first domestic oxazolidinone antibacterial drug to be marketed in China
.
Only half a year after it was approved, contezolid tablets were included in the national medical insurance list, reflecting the state's support and encouragement for innovative drugs
.
In November 2021, Mengke Pharmaceutical's application for listing on the Science and Technology Innovation Board has been accepted
.
In December 2021, Mengke Pharmaceutical announced that a new generation of oxazolidinone antibacterial drug Contezolid Tablets (Uxitai), a new generation of oxazolidinone antibacterial drugs independently developed by the company, was included in the medical insurance through the national medical insurance negotiation and is included in the new catalogue.
The only new drug against drug-resistant bacteria with a new chemical structure
.

Treating complex skin and soft tissue infections, becoming the first domestic oxazolidinone antibacterial drug to be marketed in my country

Zejing Pharmaceutical

Drugs: Donafenib Tosylate Tablets

Drugs: Donafenib Tosylate Tablets Drugs:

Highlights: Novel Multikinase Inhibitor Class Small Molecule Antitumor Drugs

Donafenib Tosylate Tablets (hereinafter referred to as "Donafenib") is an oral multi-target, multi-kinase inhibitor small-molecule anti-tumor drug developed by Zejing Pharmaceutical.
intellectual property
.
Donafenib was approved by the NMPA in June 2021
.
Recently, Zejing Pharmaceutical stated on the investor interaction platform that the company's first Class 1 new drug, Donafenib, has been listed and entered into medical insurance, and the company's business operation team is actively promoting the access of Donafenib to hospitals
.
In just about 3 months, more than 200 hospitals have been admitted, and the company's sales work is being actively promoted
.

In just about 3 months, more than 200 hospitals have been admitted, and the company's sales work is being actively promoted

Novartis

Drug: Ofatumumab

Drugs: Ofatumumab Drugs:

Highlights: Breakthrough innovative drugs in the treatment of multiple sclerosis

On December 21, 2021, the State Food and Drug Administration issued an announcement to approve the import registration application of the rare disease treatment drug ofatumumab injection through the priority review and approval process for the treatment of relapsing multiple sclerosis in adults, including clinical trials.
Isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis
.
Ofatumumab injection is an anti-human CD20 fully human immunoglobulin G1 monoclonal antibody, targeting the CD20 molecule to achieve therapeutic effects by inducing B cell lysis
.
The launch of this variety provides patients with a treatment option
.
On March 24 this year, ofatumumab was prescribed for the first time in China, marking the official launch of a breakthrough innovative drug in the global multiple sclerosis treatment field in China
.

Hengrui Medicine : Haitrombopag Ethanolamine Tablets

Hengrui Medicine Drugs: Haitrombopag Ethanolamine Tablets Drugs:

Highlights: Small molecule TPO-R drugs have broad market prospects

On June 19, 2021, Hengrui's (600276.
SH) class 1 new drug "Hytrombopag ethanolamine tablets" was approved for marketing, which is used for patients with increased bleeding risk due to thrombocytopenia and clinical conditions.
Adult patients with chronic primary immune thrombocytopenia who do not respond well to protein and other treatments, and adults with severe aplastic anemia who do not respond well to immunosuppressive therapy
.
On January 11, 2022, Hengrui Medicine announced that the company has received a letter from the US FDA regarding the approval of the clinical trial of Hytrombopag ethanolamine tablets, and will conduct a phase III clinical trial in the near future
.
The company claims that the drug-related projects have invested about 213.
1 million yuan in research and development
.

Chi-Med

Drugs: Sivotinib Tablets

Drugs: Sivotinib Tablets Drugs:

Highlight: First approved selective MET inhibitor

In June 2021, sevolitinib received conditional approval from the NMPA for the treatment of patients with non-small cell lung cancer with MET exon 14 skipping mutations who have progressed after systemic therapy or who cannot receive chemotherapy
.
Sivotinib is currently being developed as a monotherapy or in combination with other drugs to treat a variety of tumor types, including lung, kidney and gastric cancers
.
Since then, China has ushered in the first approved selective MET inhibitor, and civotinib has become the third new anti-cancer drug launched by Hutchison after fruquintinib and surufatinib
.
The development of first-generation MET inhibitors has been plagued by nephrotoxicity, as their metabolites crystallize in the kidney due to poor solubility, leading to kidney damage
.
In response to this problem, Chi-Med has developed a nephrotoxic-free savatinib, which was finally successfully launched
.
The IC50 of savatinib and cMET is 5nM, and it has potent activity against MET Y1268T, but weaker activity against other mutants, and savatinib has good kinase selectivity
.
The medicine is 200mg*21 tablets in a box, and the price is about 8588 yuan/box
.

China ushered in the first approved selective MET inhibitor, and sivotinib has become Hutchison’s third new anti-cancer drug after fruquintinib and surufatinib

Hisun Pharmaceutical

Drugs: Haibo Maibu Tablets

Drugs: Haibo Maibu Tablets Drugs:

Highlights: Hisun Pharmaceutical's first approved innovative drug

On June 28, 2021, Hisun Pharmaceutical obtained the "Drug Registration Certificate" issued by NMPA and was officially approved for production.
This is also the first innovative drug approved by Hisun Pharmaceutical
.
Haibo Maibu Tablet is a class 1 lipid-lowering drug developed by Hisun Pharmaceuticals for the treatment of primary hypercholesterolemia.
Its mechanism of action is to inhibit food and enterohepatic circulating cholesterol by acting on the small intestinal brush border transporter NPC1LI.
absorb
.
National Class 1 new drugs refer to drugs that belong to the first category in the drug registration classification.
Among them, Class 1 chemical drugs refer to innovative drugs that have not been marketed at home and abroad.
Therefore, national Class 1 new drugs are highly innovative and represent the The highest level of drug innovation in China's drug registration classification
.
In short, Haibo Maibu Tablet is not only a brand-new drug first invented in the world, but also has a remarkable curative effect
.
Before the approval, Hisun Pharmaceutical's research and development investment in this product has reached 289 million yuan
.

Haibo Maibu Tablet is not only a brand-new drug first invented in the world, but also has a remarkable curative effect.

Eddie Pharmaceuticals

Drugs: Ainovirine

Drugs: Ainovirine Drugs:

Highlights: National Class 1 New Drugs in the Field of Anti-AIDS

On June 28, 2021, the State Food and Drug Administration issued an announcement that the Class 1 innovative drug Ainovirine Tablets declared by Jiangsu Aidi Pharmaceutical Co.
, Ltd.
passed the priority review and approval process and was approved for marketing
.
The drug is used in combination with nucleoside antiretroviral drugs to treat adult HIV-1 infection-naïve patients
.
On December 3, 2021, Aidi Pharmaceutical announced in the evening that the company's new national class 1 drug in the field of anti-AIDS, ainovirine, passed the medical insurance negotiation and was included in the national medical insurance catalog for the first time
.

For use in combination with nucleoside antiretroviral drugs in the treatment of adult HIV-1 infection-naïve patients

Innovation is a must for the entire biopharmaceutical industry
.
At the same time, the innovation of biomedicine requires high technology and high investment, which also means that the entire industry has both opportunities and risks
.
The long cycle and high investment of innovative drugs determine the inevitability of high pricing
.
However, high pricing has blocked a large number of patients with limited economic conditions from the door, resulting in more and more attention for innovative drugs to enter medical insurance through national negotiations
.
How to solve the payment problem has almost become a key to whether domestic innovative drugs can be commercialized in China
.

How to solve the payment problem has almost become a key to whether domestic innovative drugs can be commercialized in China

References:

[1]https:// [2]http:// [3] http:// http:// [4] https:// https:// [5] https:// https:// [6] New high! In 2021, China's State Food and Drug Administration "officially announced" the approval of these 24 new drugs https:// New high! In 2021, China's State Food and Drug Administration "officially announced" the approval of these 24 new drugs https:// [7] BeiGene Announces Fourth Quarter and Full Year 2021 Financial Results https:// BeiGene Announces Fourth Quarter and Full Year 2021 Financial Results https:// [8] Hansen Pharmaceutical: To achieve operating income of 9.
935 billion yuan in 2021 https:// Hansen Pharmaceutical: To achieve operating income of 9.
935 billion yuan in 2021 https:// [9] https:// https://

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Mixed joy?

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