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Recently, the product pipeline of CSPC Pharmaceutical Group has been dynamically frequent: the production of exclusive varieties of new indications, the first review of dronedarone hydrochloride tablets, and the first clinical approval of ADC drug SYS6002.
.
.
At present, CSPC has 63 new drugs in the clinical application stage or above, 51 Class 1 new drugs concentrated in the anti-tumor field, and 12 non-Class 1 new drugs focusing on high-end preparations and blockbuster biosimilars.
In terms of generic drugs, the company currently has 85 varieties evaluated (23 are the first), 19 new classification declaration varieties are under review, of which 11 have not yet been approved for the first generic (including the first generic of dosage form).
.
.
At present, CSPC has 63 new drugs in the clinical application stage or above, 51 Class 1 new drugs concentrated in the anti-tumor field, and 12 non-Class 1 new drugs focusing on high-end preparations and blockbuster biosimilars.
In terms of generic drugs, the company currently has 85 varieties evaluated (23 are the first), 19 new classification declaration varieties are under review, of which 11 have not yet been approved for the first generic (including the first generic of dosage form).
It won 17 heavy varieties and 85 evaluated varieties
Since October, CSPC has approved the production of a number of generic drugs with new classifications and evaluated as such, among which mabaloxavir tablets are the first imitation, and tofacitinib citrate sustained-release tablets are the second domestic approved
.
According to data from Minai.
com, since 2022, CSPC has approved 17 varieties for marketing, including 15 generic drugs and 2 new drugs
.
.
According to data from Minai.
com, since 2022, CSPC has approved 17 varieties for marketing, including 15 generic drugs and 2 new drugs
.
Since 2022, CSPC has been approved for marketing
Source: Minai.
com China Declaration Progress (MED) database
com China Declaration Progress (MED) database
15 generic drugs were all submitted for production under the newly registered classification, and were deemed to have been evaluated after being approved for production, of which mabaloxavir tablets were the first generic + the first to be evaluated; Among the two new drugs, Duvilise capsule is the first PI3K inhibitor in China, and mitoxantrone hydrochloride liposomal injection is the world's first marketed mitoxantrone nanodrug
.
.
At present, 85 varieties of CSPC Pharmaceutical Group have passed or are deemed to have passed the consistency evaluation, of which 23 are the first/exclusive evaluation, mabaloxavir tablets, amphotericin B cholesterol sulfate complex for injection, sunitinib malate capsules, paclitaxel for injection (albumin-bound type), etc.
are the first imitation + first review
.
are the first imitation + first review
.
Appraisal of CSPC Pharmaceutical Group
Note: With * is the first/exclusive review
Source: Minai.
com China Declaration Progress (MED) database
com China Declaration Progress (MED) database
From the perspective of therapeutic areas, 85 varieties cover 8 therapeutic categories, mainly concentrated in systemic anti-infective drugs (27), nervous system drugs (13) and anti-tumor and immunomodulatory agents (13).
In the current six batches of seven rounds of chemical drug procurement, CSPC Group has 1, 2, 9, 6, 3 and 9 varieties respectively won the bid, a total of 30 varieties, and a number of newly listed generic drugs were rapidly increased after national procurement
.
In the upcoming eighth batch of centralized procurement, CSPC has 9 evaluated varieties that have met the full competition conditions
of 4 or more.
.
In the upcoming eighth batch of centralized procurement, CSPC has 9 evaluated varieties that have met the full competition conditions
of 4 or more.
51 Class 1 new drugs, 3 blockbuster monoclonal antibody sprints, storming high-end preparations
Recently, CSPC Pharmaceutical Group has made new progress in the research and development of new drugs: the exclusive variety of recombinant human TNK tissue plasminogen activator has been reported for production, the 2.
2 new drug octreotide long-acting injection has been declared for clinical trial for the first time, and the ADC drug SYS6002 has been approved for clinical trial for the first time.
.
.
2 new drug octreotide long-acting injection has been declared for clinical trial for the first time, and the ADC drug SYS6002 has been approved for clinical trial for the first time.
.
.
According to data from Minai.
com, including the products introduced by cooperation, 63 new drugs (excluding new indications for the development of new drugs that have been marketed) are in the clinical application stage
or above in China.
com, including the products introduced by cooperation, 63 new drugs (excluding new indications for the development of new drugs that have been marketed) are in the clinical application stage
or above in China.
In terms of drug types, 39 were chemical drugs, 23 were therapeutic biological products, and 1 was a proprietary Chinese medicine; From the perspective of registration classification, 51 of the 63 new drugs are Class 1 new drugs
.
.
CSPC Pharmaceutical Group is developing Class 1 new drugs in China
Source: Minai.
com China Clinical Trial Library
com China Clinical Trial Library
51 Class 1 new drugs are concentrated in the field of antitumor drugs, and the digestive system, cardiovascular and cerebrovascular system, respiratory system, nervous system, etc.
are also involved
.
From the perspective of drug mechanism of action, chemical drugs are mainly multi-target inhibitors, and biological drugs cover monoclonal antibodies, bispecific antibodies, ADC drugs, etc
.
are also involved
.
From the perspective of drug mechanism of action, chemical drugs are mainly multi-target inhibitors, and biological drugs cover monoclonal antibodies, bispecific antibodies, ADC drugs, etc
.
7 Class 1 new drugs have entered phase III (including phase II/III) and above, and can be marketed, of which rezetinib (third-generation EGFR inhibitor) and nallesulizumab (RANKL monoclonal antibody) have been submitted for marketing applications, of which naloxumab is the first domestic RANKL antibody new drug reported for production, and the domestic drug with the same target approved for marketing is Amgen's denosumab, which has global sales of more than 5 billion US dollars
in 2021.
in 2021.
In addition to Class 1 new drugs, CSPC also has 12 improved new drugs or biosimilars in the clinical application stage
or above.
or above.
Other new drugs under research in China are under research in China
Source: Minai.
com China Clinical Trial Library
com China Clinical Trial Library
Improved new drugs have attacked high-end preparations such as liposomes, micelles, and albumin-binding types, and many of the generic drugs involved in these products exceeded 1 billion yuan in 2021 in China's public medical institutions, including alprostadil (1 billion+), docetaxel (3 billion+), irinotecan (1.
8 billion+), octreotide (2.
4 billion+), etc
.
8 billion+), octreotide (2.
4 billion+), etc
.
Roche's pertuzumab, Novartis/Roche's omalizumab, and Johnson & Johnson/Mitsubishi Tanabe's ustekinumab had global sales of more than US$3.
9 billion, US$3.
3 billion and US$9.
3 billion
respectively in 2021.
These three monoclonal antibodies have not been approved for biosimilars in China, and from the perspective of domestic sales, the sales of pertuzumab in China's public medical institutions in 2021 exceeded 2.
5 billion yuan
.
9 billion, US$3.
3 billion and US$9.
3 billion
respectively in 2021.
These three monoclonal antibodies have not been approved for biosimilars in China, and from the perspective of domestic sales, the sales of pertuzumab in China's public medical institutions in 2021 exceeded 2.
5 billion yuan
.
18 new products are on the way, and 11 varieties are the first to imitate
In terms of generic drugs declared for the new classification, the marketing applications of olaparib tablets and paclitaxel for injection (albumin-bound type) (II.
) were recently undertaken by CDE
.
Since 2022, CSPC has submitted marketing/clinical applications
for 13 varieties under the new registration classification.
) were recently undertaken by CDE
.
Since 2022, CSPC has submitted marketing/clinical applications
for 13 varieties under the new registration classification.
At present, CSPC has 18 varieties declared and under review under new registration classification, and the total sales scale of these 18 varieties in China's public medical institutions in 2021 will exceed 10 billion yuan, of which the annual sales of dapagliflozin tablets, rosuvastatin calcium tablets, rabeprazole sodium enteric-coated tablets exceed 2 billion yuan, and the annual sales of sacubitril valsartan sodium tablets exceed 1.
7 billion yuan
.
7 billion yuan
.
11 varieties have not been approved for marketing (including the first generic of dosage form), including olaparib tablets, irinotecan liposomal injection, pezoparib tablets, appremilaster tablets, candesartan amlodipine tablets, sacubitril valsartan sodium tablets, etc
.
.
The new classification declaration of CSPC Pharmaceutical Group is under review and there are no varieties approved for the first imitation
Source: Minai.
com China Declaration Progress (MED) database
com China Declaration Progress (MED) database
6 varieties were declared by CSPC Pharmaceutical Group exclusively/first under the newly registered classification
.
Among them, paclitaxel and irinotecan exceeded 6.
4 billion yuan and 1.
8 billion yuan respectively in terminal sales of public medical institutions in China in 2021; Amgen's Apremister (Aprist) had global sales of more than $2 billion in 2021, and the original research products were approved to enter the domestic market
in August 2021.
.
Among them, paclitaxel and irinotecan exceeded 6.
4 billion yuan and 1.
8 billion yuan respectively in terminal sales of public medical institutions in China in 2021; Amgen's Apremister (Aprist) had global sales of more than $2 billion in 2021, and the original research products were approved to enter the domestic market
in August 2021.
Source: Minainet database, company announcements, etc
Note: Minai.
com's "Drug Terminal Competition Pattern of Public Medical Institutions in China", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 15, if there is any omission, welcome to correct!
com's "Drug Terminal Competition Pattern of Public Medical Institutions in China", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 15, if there is any omission, welcome to correct!
