The fifth innovative drug of Hausen Pharmaceuticals in the anti-tumor field in 2020 is about to be approved

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On March 30, Hansen Pharmaceutical released its 2020 financial report.

From: Hansen Pharma 2020 Annual Report

According to the annual report, Hansen Pharmaceutical's main product revenue in 2019 and 2020 is as follows.

Insight database mapping

According to Insight, currently, Hansen Pharma’s R&D pipeline is dominated by chemical drugs, with only 1 biosimilar drug Disumab and 1 imported CD19 monoclonal antibody in clinical development.

The products that have been approved for marketing include 4 original chemical drugs, 1 improved new drug, and 57 generic drugs; while the proportion of innovative drugs in products that have entered the clinical stage has greatly increased, including 14 original chemical drugs and 23 generic drugs.

A variety of blockbuster first imitations have been submitted for production

According to the Insight database, Hansen currently has 12 generic drugs submitted for production, of which 7 generic drugs have not been approved in China.

Insight database mapping

Cabozantinib, a broad-spectrum anticancer drug

Cabozantinib is a multi-target small molecule tyrosine kinase inhibitor, developed by Exelixis and Ipsen Pharmaceuticals, with broad-spectrum anti-cancer potential.

At present, the drug has been approved by the FDA for 3 indications, including medullary thyroid cancer, renal cell carcinoma (first-line + second-line), and liver cancer (second-line).

Based on its wide range of indications, cabozantinib has great market potential in the future.

Domestic competition of cabozantinib (Insight)

From: Insight database (http://db.

Enzalutamide, 4.

Enzalutamide is a new generation of androgen receptor inhibitors for the treatment of advanced castration-resistant prostate cancer (CRPC).

In November 2019, the original enzalutamide drug was approved for import for advanced/metastatic castration-resistant prostate cancer; in November 2020, it was approved for lung metastatic castration-resistant prostate cancer.

The Insight database shows that only half a year after the original research was approved, Hansen Pharmaceuticals was the first to submit a listing application, which can be described as rapid.

Enzalutamide domestic competition (Insight)

From: Insight database (http://db.

Varenicline, used in adults to quit smoking

Varenicline is a selective partial agonist of the nicotinic acetylcholine receptor α4β2 subtype and is a first-line drug for the treatment of tobacco dependence.

According to Pfizer's financial report, Varenicline's global sales in 2019 exceeded US$1.

According to the Insight database, Hansen Pharma’s varenicline was reported for production in February 2020 and has been included in the priority review "1 year before the patent expires" and is expected to be the first imitation.
In addition, only Shandong Weizhi Encyclopedia Pharmaceutical Co.
, Ltd.
has just reported production on March 25, 2021, one year later; Shandong Langnuo Pharmaceutical and Jiangsu Jiayi Pharmaceutical are in the BE trial stage.

Varenicline domestic competition (Insight)

From: Insight database (http://db.
dxy.
cn/v5/home/)

The fifth innovative drug will be approved soon, and the cooperation project will be submitted for production

From the perspective of the treatment field, the proportion of anti-cancer drugs in Hansen's early pipeline has increased significantly, and it is expected that the focus will be on the development of anti-cancer drugs in the later period.

Insight database mapping

The fastest-growing species is the new class 1 hepatitis B drug imitenofovir (formerly known as eimofolamine tenofovir).
The drug is independently developed by Hansen Pharmaceuticals.
It is a new type of nucleotide reverse transcriptase inhibitor, which inhibits reverse transcriptase in a similar way to nucleoside reverse transcriptase inhibitors, thereby simultaneously having potential for anti-HIV-1activity.
Recently, Hansen has submitted the first round of supplementary information, and the industry predicts that the drug is expected to be approved in the first half of the year at the earliest.

As a prodrug of tenofovir (TFV), by optimizing the structure, imitenofovir has higher plasma stability than tenofovir, lower TFV exposure, and higher safety; it is metabolized by hepatocytes and is active The metabolite tenofovir diphosphate (TFV-DP) accumulates in a high concentration in the liver to achieve liver targeting and improve the availability of drugs.
Only 1/10 of the dose of tenofovir disoproxil fumarate is required to obtain similar antiviral effects.

Hepatitis B is a serious public health problem facing the world as well as our country.
It is estimated that there are about 70 million cases of HBV infection in my country, of which about 20-30 million cases of chronic hepatitis B patients requiring antiviral therapy, ranking first in the world.
Hansen's new hepatitis B drug is expected to capture the huge market in the hepatitis B field after approval and provide new treatment options for corresponding patients.

In terms of cooperation, Hansen has both introduced and authorized externally in recent years.
It has also reached a US$1.
5 billion cooperation with Atomwise on the AI ​​drug discovery program, focusing on the screening of active compounds that are difficult to drug targets, and targeting in multiple therapeutic areas.
Design and discover potential drug candidates for 11 undisclosed targets to enrich Hansen's new drug product portfolio.

Among the introduction projects in recent years, the fastest progress is the CD19 monoclonal antibody Inebilizumab, which was reported for production in October 2020.
This monoclonal antibody is a product introduced by Hansen from Viela Bio with a maximum down payment + milestone payment of US$220 million in May 2019.
It is the first biological drug declared by Hansen and the first CD19 list in China.
anti.

In February 2021, Hansen cooperated with SCYNEXIS to introduce the world's first innovative triterpene antifungal agent ibrexafungerp.
The drug has broad-spectrum activity and can take advantage of the therapeutic advantages of intravenous and oral preparations.
At present, the original research company has submitted a new drug marketing application to the FDA, and the PDUFA date is June 1, 2021.
If approved, the product may become the first new antifungal and the first and only non-azole therapy for vaginal yeast infections in more than 20 years.