Xinlitai "strikes" innovative drugs!

"Buy, buy, buy" transactions are hot.
Recently, Xinlitai introduced a long-acting hypoglycemic drug for US$27 million, and the company just terminated the transaction of an oncology drug in August, and the pipeline was further optimized
.

Since the national centralized procurement, domestic pharmaceutical companies have set off a wave of innovation and transformation.

170 million yuan won the long-acting hypoglycemic drug! Terminating the oncology drug transaction and earning 26 million yuan

170 million yuan won the long-acting hypoglycemic drug! Terminating the oncology drug transaction and earning 26 million yuan

Recently, Xinlitai announced that the company intends to sign an agreement with Korea D&D to obtain the exclusive license of intellectual property rights and technical information of the innovative drug DD01 owned by D&D in mainland China, including the exclusive technology development and production of this product in mainland China.
equity market and commercial operation and so on
.

According to the progress of product research and development, the company uses self-raised funds to pay according to the development milestones, and the total amount does not exceed US$27 million (about 170 million yuan)

DD01 is a long-acting GLP-1R/GCGR dual agonist developed by D&D.
The proposed development indications are type II diabetes, obesity, non-alcoholic steatohepatitis (NASH) and other diseases
.

After the product is launched in the future, it can not only meet the unmet clinical needs of the diabetes field, but also enrich the company's innovative product line in the field of chronic disease drugs

GLP-1 receptor agonist is a popular species in the field of diabetes treatment in recent years, and the market is growing strongly
.

Meinenet data shows that in 2020, China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China public medical institutions) terminal GLP-1 agonist sales exceeded 1.

Sales of terminal GLP-1 agonists in public medical institutions in China (unit: ten thousand yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

In recent years, license-in (authorized introduction) transactions in the domestic pharmaceutical market have been hot, and local pharmaceutical companies have taken this to quickly enter the innovative drug track and enrich their pipeline of products under research
.

Oncology is a hot area of ​​license-in, but Xinlitai recently terminated an oncology drug license-in transaction, which has attracted market attention

On August 24, Xin Litai issued an announcement stating that it had terminated the cooperation with Viracta of the United States on the exclusive license to use the drug naatinostat
.

Because Xin Litai has contributed to the preliminary research and cooperation of naatinostat, Viracta will pay Xin Litai US$ 4 million (approximately 26 million yuan)

nanatinostat is Viracta developed a new generation of anticancer drugs, in combination with the oral antiviral for the treatment of cancer associated with EB virus, such as EB virus-positive lymphoma, nasopharyngeal carcinoma and gastric cancer
.

Regarding the reasons for the termination, Xinlitai said that in recent years, based on the industry development trend and the company's focus, the company has focused more on innovative research and development in the cardio-cerebrovascular field.
The chemical drug R&D projects and scientific research teams are all deployed in cardio-cerebrovascular, diabetes, and orthopedics.
Wait for chronic disease medication
.

In recent years, the domestic anti-tumor drug market has continued to rise.
In 2020, the sales of terminal anti-tumor drugs in public medical institutions in China will exceed 100 billion yuan, a year-on-year increase of 9.
63%
.

However, the current domestic pharmaceutical companies are gathering anti-cancer drug research and development, and the market competition is becoming fierce; and the new CDE regulations emphasize that anti-cancer drug research and development are "clinical value-oriented"; naatinostat technology transfer has not made substantial progress, and the indications are small, or Xin Litai decided to terminate the transaction factors

19 varieties have been reviewed! Generic drugs "empty windows", slimming

19 varieties have been reviewed! Generic drugs "empty windows", slimming

Xinlitai passed/deemed passed the consistency evaluation variety

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

Since the beginning of this year, Xinlitai has passed/deemedly passed the consistency evaluation of 6 varieties, including sitafloxacin tablets, erlotinib hydrochloride tablets, cefuroxime sodium for injection, imatinib mesylate tablets, Bivarudine and Rivaroxaban tablets for injection
.

Up to now, Xinlitai has 19 varieties (32 product specifications) passed/deemed to pass the consistency evaluation, of which 8 varieties have been evaluated for the first time
.

The 19 varieties cover 7 treatment categories, of which cardiovascular system drugs, blood and hematopoietic system drugs, and systemic anti-infective drugs all involve 4 varieties

In five batches and six rounds of national centralized procurement, Xinlitai has a total of 11 varieties selected, focusing on the field of cardiovascular and cerebrovascular
.
According to Xinlitai’s 2021 mid-year report, the company has won bids for multiple products and quickly opened up the market, bringing stable cash flow and operational improvement to the company; in the antiplatelet drug market, as clinical demand continues to grow, clopidogrel, clopidogrel, Tigrelor's sales volume still maintained a double-digit growth
.

Only 4 of the 19 reviewed varieties have not been included in the collection, including erlotinib hydrochloride tablets, paroxetine hydrochloride enteric-coated sustained-release tablets, sitafloxacin tablets, and levetiracetam sustained-release tablets, all of which are new Approved varieties, of which Erlotinib Hydrochloride Tablets and Sitafloxacin Tablets have met the requirements for centralized procurement
.

At present, Xinlitai only has a generic drug application for sacubitril and valsartan sodium tablets under review
.
Sacubitril and Valsartan is the world's first angiotensin receptor enkephalinase inhibitor (ARNI), and it has been approved for heart failure and hypertension indications in China
.
According to data from Meinnet.
com, Novartis' global sales of valsartan and sacubitril will be 2.
497 billion U.
S.
dollars in 2020
.
Eight domestic companies including Chia Tai Tianqing, CSPC, Kelun Pharmaceutical, and Better Pharmaceutical have submitted applications for the listing of this product
.
It is worth looking forward to who will win the first imitation .

It is worth noting that Xinlitai has been in the "window period" of generic drugs for more than two years
.
Rivaroxaban is the last generic drug of Xin Litai to declare for listing.
It was contracted by CDE on June 27, 2019 and approved for listing on January 27, 2021
.

Previously, Xinlitai mentioned in its 2019 annual report that “strategic optimization of the pipeline in research, and termination of some anti-tumor biosimilars and antibiotics in the clinical stage”
.

In the 2020 annual report, Xinlitai stated that in order to further optimize the pipeline of research and focus on the development and promotion of innovative products, it has transferred dapoxetine hydrochloride, erlotinib hydrochloride, rivaroxaban, and recombinant human follicle stimulating hormone-CTP fusion protein The related rights and interests of injections and other projects received a total of 172.
68 million yuan in technology transfer fees
.

15 innovative drugs are dazzling! Deeply cultivate the field of chronic diseases

15 innovative drugs are dazzling! Deeply cultivate the field of chronic diseases

Xinlitai is mainly researching new drugs

In addition to commercialized products, Xinlitai currently has 15 innovative drugs under development, with the cardiovascular field as the core, expanding into the fields of hypoglycemia, orthopedics, anti-tumor and other fields
.
Among them, there are 6 medicines for cardiovascular and cerebrovascular medicine, 3 medicines for orthopedics and diabetes
.
The 6 innovative drugs are in the phase III clinical stage, and the tumor immunity drug SAL008 and the anti-severe depression drug SAL0114 are about to apply for IND
.

Among the 6 cardio-cerebral vascular drugs, the new class 1 drug S086 tablets (sacubata triallisartan calcium) and the class 2.
3 new drug allisartan medoxomil and amlodipine tablets are in the phase III clinical stage and are expected to be launched in 2024/2025
.
According to data from Meinenet, in 2020, the sales of terminal cardio-cerebral vascular drugs in public medical institutions in China will exceed 100 billion yuan
.
At present, there are not many domestic companies focusing on the field of cardiovascular and cerebrovascular research and development of innovative drugs
.

Teriparatide is a blockbuster drug in the osteoporosis drug market, and the original manufacturer is Eli Lilly
.
According to data from Mi Nei.
com, Eli Lilly’s global sales of teriparatide will be US$1.
046 billion in 2020
.
Xinlitai's teriparatide powder injection has been approved for marketing in 2019; teriparatide water injection has been submitted for marketing, and is expected to be approved as soon as the end of 2021; long-acting teriparatide is in phase III clinical trials Stage
.

Ennarestat is a potent orally reversible hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
It is a new mechanism and innovative drug for the treatment of renal anemia.
It is in the phase III clinical stage
.
Renal anemia is a common complication of chronic kidney disease (CKD).
The first new drug for renal anemia HIF-PHI, rosarestat, was approved for marketing in China in 2018, and AstraZeneca’s rosarestat sales revenue in 2020 For 30 million U.
S.
dollars
.
Xinlitai's Ennarestat is expected to apply for NDA by the end of 2021 and be approved in 2022
.

Data source: Mi Nei.
com database, company announcement

Note: The statistics are as of September 28, if there are any omissions, please correct me!