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"Nuggets Innovative Drugs" was jointly launched by the Daily Economic News and Yaodu Data, aiming to interpret the progress and trends of new drug research and development, analyze product competitiveness and market prospects, gain insight into the context of pharmaceutical capital, and witness the high-quality development of the pharmaceutical industry
.
Every reporter: Chen Xingyaodu Editor: Amphetamine From the listing and declaration data, domestic PD-L1 has entered an intensive harvest period
.
With Corning's pioneering innovative subcutaneous administration of verimab, the competition for innovative formulations of PD-L1 inhibitors has intensified
.
On January 16, the clinical application of the oral small molecule PD-L1 inhibitor independently developed by Betta Pharmaceuticals was approved
.
On January 16, Betta Pharmaceuticals announced that the clinical trial of BPI-371153 capsules declared by the company for the treatment of patients with advanced or metastatic solid tumors or relapsed/refractory lymphoma has obtained a clinical trial approval notice
.
BPI-371153 is an oral small molecule PD-L1 inhibitor independently developed by Betta Pharmaceuticals
.
Betta Pharmaceuticals stated in the announcement that compared with PD-1/PD-L1 antibody drugs, oral small-molecule PD-L1 inhibitors may have similar clinical benefits, and are convenient to take, lower in production costs, and more accessible.
Sex has also improved significantly
.
Up to now, no small molecule PD-L1 inhibitor has been approved for marketing in the world, and BPI-371153 belongs to the "innovative drug that has not been marketed at home and abroad"
.
01 The new stage of PD-L1 competition The update of the differentiated drug delivery mode may mean that the competition of PD-L1 drugs has entered the "next stage"
.
Yaodu data shows that up to now, a total of 12 PD-1/PD-L1 models have been listed in China, including 6 domestically produced PD-1s and 2 domestically produced PD-L1s (Corning Jereh's Nvolimab and CStone Pharmaceuticals).
sugalimumab), 2 imported PD-1 and 2 imported PD-L1 (Roche's atezolizumab and AstraZeneca's durvalumab)
.
There are 6 models that are in the stage of application for listing, including Zhaoke Pharmaceutical's Shoukalimab, Kelun Pharmaceutical's Tetlimumab and Hengrui Medicine's adebelimumab
.
There are 60, 44 and 17 drugs in clinical phase I, II and III, respectively, covering a variety of molecular types such as monoclonal antibodies, dual/polyclonal antibodies, and small molecules
.
Judging from the listing and declaration data, domestic PD-L1 has entered an intensive harvest period
.
It is worth noting that, in addition to the different indications, the existing PD-L1 inhibitors have begun to focus on seeking differentiation in the way of administration
.
Taking Corning Jerienvolumab as an example, it is administered by subcutaneous injection, which has more safety and compliance advantages than traditional intravenous drip administration
.
The BPI-371153 is administered orally, which is the difference between this PD-L1 inhibitor
.
The research report of the brokerage company shows that the oral administration of PD-L1 inhibitors has three advantages: it is convenient to administer without going to the hospital for injection administration; it can be combined with other oral antitumor drugs to form an all-oral treatment plan; it can be adjusted in time.
doses, and management of immune-related adverse events
.
At the same time, oral dosage forms facilitate better control of drug production costs
.
However, the innovation of dosage forms has been a differentiation direction that PD-L1 manufacturers have seen
.
In addition to Betta Pharmaceuticals, Hongri Pharmaceuticals, Zaiji Pharmaceuticals and Arnold Pharmaceuticals have all received approval or application for clinical trials of oral small molecule PD-L1 inhibitors
.
Among them, Hongri Pharmaceutical's Emdiphene has started clinical trials in April 2020.
It is the first oral PD-L1 small molecule inhibitor approved for clinical trials in China, and clinical trials are currently being carried out
.
Zaiji Pharmaceutical's oral PD-L1 inhibitor MAX-10181 tablet was approved for clinical use in China in early 2021 for advanced solid tumors
.
ArnoldBio's AN4005 has also been approved for clinical use
.
02 The track is crowded, and the PD-L1 is becoming more and more "inward".
The PD-L1's "inward" trend is obvious
.
The "predecessors" of Betta Pharmaceuticals, Corning Jereh, CStone Pharmaceuticals, etc.
have all chosen to cooperate with external companies to promote the commercialization of PD-L1 products
.
Taking Corning Jereh as an example, Simcere Pharmaceuticals is responsible for the exclusive commercial promotion of its envolimab after its registration and listing in mainland China
.
The development and commercialization rights for the treatment of all viral diseases, including hepatitis B, are fully granted to Ascletis, which will pay the down payment, development, registration, commercialization milestone payments and a gradient of approximately 15% to 20% of sales Amount divided
.
CStone will sell Sugar for up to US$480 million (including US$200 million in equity investment and US$280 million in milestone payments) and US$1.
3 billion (including US$150 million in down payment and US$1.
15 billion in milestone payments) as early as 2020.
The domestic and overseas rights of limumab were transferred to Pfizer and EQRx respectively
.
This also means that CStone will not directly participate in the sales activities of sugelimab in the future
.
Betta Pharmaceuticals has not announced the commercialization plan of its oral small-molecule PD-L1 inhibitor, but in the context of PD-L1 competition closely catching up with PD-1, some companies choose to transfer commercial rights to recover R&D costs in advance
.
The researchers of "Nuggets Innovative Drugs" believe that although there are differences in the way of administration of oral PD-L1 inhibitors, the competition of PD-L1 inhibitors has a tendency to move towards a white-hot stage, and the innovation of administration methods includes the development of oral dosage forms are in progress
.
After Betta Pharmaceuticals' BPI-371153 is launched, it remains to be discussed how much first-mover advantage it can have in the innovation of drug delivery methods
.
However, Betta Pharmaceuticals is different from some innovative drug R&D companies that have not yet launched their products in that they already have products on sale
.
From 2018 to 2020, Betta Pharmaceutical's revenue reached 1.
224 billion yuan, 1.
554 billion yuan, and 1.
870 billion yuan, respectively, and its net profit reached 167 million yuan, 231 million yuan, and 606 million yuan, respectively
.
As a non-small cell lung cancer (NSCLC) treatment drug that fills the long-term gap in the field of self-developed cancer-targeted drugs in China, the small-molecule targeted anti-cancer drug icotinib hydrochloride contributes more than 90% of its revenue
.
However, under the background of the inclusion of centralized procurement and the successive listing of competing generic drugs, Betta Pharmaceuticals also urgently needs to create new growth points
.
Data source: Pharmacodia Data, https://data.
pharmacodia.
com
.
Every reporter: Chen Xingyaodu Editor: Amphetamine From the listing and declaration data, domestic PD-L1 has entered an intensive harvest period
.
With Corning's pioneering innovative subcutaneous administration of verimab, the competition for innovative formulations of PD-L1 inhibitors has intensified
.
On January 16, the clinical application of the oral small molecule PD-L1 inhibitor independently developed by Betta Pharmaceuticals was approved
.
On January 16, Betta Pharmaceuticals announced that the clinical trial of BPI-371153 capsules declared by the company for the treatment of patients with advanced or metastatic solid tumors or relapsed/refractory lymphoma has obtained a clinical trial approval notice
.
BPI-371153 is an oral small molecule PD-L1 inhibitor independently developed by Betta Pharmaceuticals
.
Betta Pharmaceuticals stated in the announcement that compared with PD-1/PD-L1 antibody drugs, oral small-molecule PD-L1 inhibitors may have similar clinical benefits, and are convenient to take, lower in production costs, and more accessible.
Sex has also improved significantly
.
Up to now, no small molecule PD-L1 inhibitor has been approved for marketing in the world, and BPI-371153 belongs to the "innovative drug that has not been marketed at home and abroad"
.
01 The new stage of PD-L1 competition The update of the differentiated drug delivery mode may mean that the competition of PD-L1 drugs has entered the "next stage"
.
Yaodu data shows that up to now, a total of 12 PD-1/PD-L1 models have been listed in China, including 6 domestically produced PD-1s and 2 domestically produced PD-L1s (Corning Jereh's Nvolimab and CStone Pharmaceuticals).
sugalimumab), 2 imported PD-1 and 2 imported PD-L1 (Roche's atezolizumab and AstraZeneca's durvalumab)
.
There are 6 models that are in the stage of application for listing, including Zhaoke Pharmaceutical's Shoukalimab, Kelun Pharmaceutical's Tetlimumab and Hengrui Medicine's adebelimumab
.
There are 60, 44 and 17 drugs in clinical phase I, II and III, respectively, covering a variety of molecular types such as monoclonal antibodies, dual/polyclonal antibodies, and small molecules
.
Judging from the listing and declaration data, domestic PD-L1 has entered an intensive harvest period
.
It is worth noting that, in addition to the different indications, the existing PD-L1 inhibitors have begun to focus on seeking differentiation in the way of administration
.
Taking Corning Jerienvolumab as an example, it is administered by subcutaneous injection, which has more safety and compliance advantages than traditional intravenous drip administration
.
The BPI-371153 is administered orally, which is the difference between this PD-L1 inhibitor
.
The research report of the brokerage company shows that the oral administration of PD-L1 inhibitors has three advantages: it is convenient to administer without going to the hospital for injection administration; it can be combined with other oral antitumor drugs to form an all-oral treatment plan; it can be adjusted in time.
doses, and management of immune-related adverse events
.
At the same time, oral dosage forms facilitate better control of drug production costs
.
However, the innovation of dosage forms has been a differentiation direction that PD-L1 manufacturers have seen
.
In addition to Betta Pharmaceuticals, Hongri Pharmaceuticals, Zaiji Pharmaceuticals and Arnold Pharmaceuticals have all received approval or application for clinical trials of oral small molecule PD-L1 inhibitors
.
Among them, Hongri Pharmaceutical's Emdiphene has started clinical trials in April 2020.
It is the first oral PD-L1 small molecule inhibitor approved for clinical trials in China, and clinical trials are currently being carried out
.
Zaiji Pharmaceutical's oral PD-L1 inhibitor MAX-10181 tablet was approved for clinical use in China in early 2021 for advanced solid tumors
.
ArnoldBio's AN4005 has also been approved for clinical use
.
02 The track is crowded, and the PD-L1 is becoming more and more "inward".
The PD-L1's "inward" trend is obvious
.
The "predecessors" of Betta Pharmaceuticals, Corning Jereh, CStone Pharmaceuticals, etc.
have all chosen to cooperate with external companies to promote the commercialization of PD-L1 products
.
Taking Corning Jereh as an example, Simcere Pharmaceuticals is responsible for the exclusive commercial promotion of its envolimab after its registration and listing in mainland China
.
The development and commercialization rights for the treatment of all viral diseases, including hepatitis B, are fully granted to Ascletis, which will pay the down payment, development, registration, commercialization milestone payments and a gradient of approximately 15% to 20% of sales Amount divided
.
CStone will sell Sugar for up to US$480 million (including US$200 million in equity investment and US$280 million in milestone payments) and US$1.
3 billion (including US$150 million in down payment and US$1.
15 billion in milestone payments) as early as 2020.
The domestic and overseas rights of limumab were transferred to Pfizer and EQRx respectively
.
This also means that CStone will not directly participate in the sales activities of sugelimab in the future
.
Betta Pharmaceuticals has not announced the commercialization plan of its oral small-molecule PD-L1 inhibitor, but in the context of PD-L1 competition closely catching up with PD-1, some companies choose to transfer commercial rights to recover R&D costs in advance
.
The researchers of "Nuggets Innovative Drugs" believe that although there are differences in the way of administration of oral PD-L1 inhibitors, the competition of PD-L1 inhibitors has a tendency to move towards a white-hot stage, and the innovation of administration methods includes the development of oral dosage forms are in progress
.
After Betta Pharmaceuticals' BPI-371153 is launched, it remains to be discussed how much first-mover advantage it can have in the innovation of drug delivery methods
.
However, Betta Pharmaceuticals is different from some innovative drug R&D companies that have not yet launched their products in that they already have products on sale
.
From 2018 to 2020, Betta Pharmaceutical's revenue reached 1.
224 billion yuan, 1.
554 billion yuan, and 1.
870 billion yuan, respectively, and its net profit reached 167 million yuan, 231 million yuan, and 606 million yuan, respectively
.
As a non-small cell lung cancer (NSCLC) treatment drug that fills the long-term gap in the field of self-developed cancer-targeted drugs in China, the small-molecule targeted anti-cancer drug icotinib hydrochloride contributes more than 90% of its revenue
.
However, under the background of the inclusion of centralized procurement and the successive listing of competing generic drugs, Betta Pharmaceuticals also urgently needs to create new growth points
.
Data source: Pharmacodia Data, https://data.
pharmacodia.
com
