Hansoh Pharma's innovative drug revenue will rise by 169% in 2021!

On March 29, Hansoh Pharma announced its 2021 annual results

It is worth noting that Hansoh Pharma's innovative drug sales revenue in 2021 was 4.

It is worth noting that Hansoh Pharma's innovative drug sales revenue in 2021 was 4.

From: Enterprise Annual Report

From the perspective of revenue in various therapeutic areas, the revenue of anti-tumor drugs is increasing year by year.

From: Enterprise annual report, Insight database collation

break out! In 2021, 14 new drugs were first reported for clinical trials, the first biological drug was approved recently, and the early pipeline was betting on ADC

break out! In 2021, 14 new drugs were first reported for clinical trials, the first biological drug was approved recently, and the early pipeline was betting on ADC

According to the Insight database, before 2021, Hansoh Pharma maintained an average annual rate of 1-3 new drug project declarations; after 2021, the group started the explosive declaration of new projects and declared 14 new drug projects in the same year

Clinical application of innovative drug projects of Hansoh Pharma in the past 5 years

*Only the first declaration is counted

From: Insight Database Project Progress Module (http://db.

Hansoh Pharma's innovative drug R&D focuses on chemical drugs, especially EGFR targets

Hansoh Pharma's innovative drug R&D focuses on chemical drugs, especially EGFR targets

Gantt chart for the development of domestic indications for "Ametinib"

From: Insight Database Project Progress Module (http://db.

In May and July 2021, Hansoh Pharma successively applied for two other EGFR inhibitors, HS-10376 and HS-10375, both of which have already started clinical trials

Lung cancer is the second most common cancer in the world with the highest mortality rate, of which 85% are non-small cell lung cancer (NSCLC)

EGFR target hierarchy (Insight)

*The Insight database contains new drugs under research with different levels of targets, and you can directly view the competition pattern of each subdivided target under EGFR

Among Asian patients, the proportion of EGFR mutations is even higher

EGFR-C797S Domestic Competitive Landscape

From: Insight Database Project Progress Module (http://db.

In terms of biological drugs, Hansoh Pharma established a biological drug research and development center in 2016 to apply international cutting-edge technologies to develop and industrialize innovative biological drugs.

In terms of biological drugs, monoclonal antibodies, double antibodies, ADCs and fusion proteins

Before 2021, the company only had one biological drug HS-20090 (denosumab biosimilar) in clinical development, but in July 2021, two innovative biological drugs, HS-20089 and HS-20093, were continuously declared.

It is worth noting that the first stop of Hansoh's independent research and development of biological drugs falls in the field of ADC

It is worth noting that the first stop of Hansoh's independent research and development of biological drugs falls in the field of ADC
.

The B7 family is an important immunomodulatory protein, including 10 members, such as CD80, CD86, PD-L1 (B7-H1), PD-L2 (B7-DC), B7-H3, B7-H4,
etc.
B7-H1 is PD-L1, and the PD-1/L1 pathway has played an important role in tumor immunotherapy and has become a cornerstone drug; studies have found that B7-H3 and B7-H4 are widely expressed in various types of tumors , plays a key role in regulating the anti-tumor immune response, and thus becomes a potential anti-cancer target
.

According to the global new drug module of the Insight database, there are currently 15 new drugs under development for the B7-H4 target in the world, including 5 ADC drugs.
HS-20089 is the only B7-H4 ADC that has entered clinical development in China.
Phase I clinical trials were initiated on November 22, 2021
.
Last Friday, AstraZeneca's similar drug AZD8205 also submitted an IND application in China
.

HS-20089

HS-20089 Domestic Project Overview

ADCs under investigation targeting B7-H4

From: Global New Drug Module of Insight Database (http://db.
dxy.
cn/v5/home/)

Among domestic companies, Harbin Pharmaceutical is also focusing on this target, but its research and development focus is on double antibodies
.
The company also has B7-H4/CD3 dual antibody HBM7004 and B7-H4/4-1BB dual antibody HBM7008, the latter of which was just approved for clinical use in Australia on February 28, the world's first
.

HS-20093 targets B7-H3.
From the perspective of the global R&D pattern, this target is hotter than B7-H4.
There are 35 research projects in total, including 11 CAR-Ts, 10 double antibodies, and ADCs.
8
.
However, in China, only the differentiated monoclonal antibody Ibrutinib (TJ271) with Fc optimization function introduced by Tianjing Biotechnology is currently under development, and the global progress has progressed to Phase II/III, while domestic clinical trials have not yet started
.

HS-20093

Self-developed + BD two-wheel drive, cooperation with multiple technology platforms

Self-developed + BD two-wheel drive, cooperation with multiple technology platforms

Nowadays, for domestic pharmaceutical companies, finding innovative products with proof-of-concept and highly differentiated early-stage projects is an important way to fill the clinical stage and commercial pipeline; at the same time, actively carrying out platform cooperation with Biotech to give full play to the strengths of both parties is conducive to enhancing the The innovative hematopoietic capabilities of enterprises and the development of potential first-in-class new drugs with high competitiveness are also conducive to the faster introduction of new drugs with real clinical value to the clinic
.

In 2021, Hansoh Pharma's BD expenses are 374 million yuan
.
In terms of new drug introduction, the company has introduced two clinical-stage products, including the antifungal drug Ibrexafungerp and the engineered ligand capture body KER-050
.

In 2021, Hansoh Pharma's BD expenses are 374 million yuan
.
In terms of new drug introduction, the company has introduced two clinical stage products,

Ibrexafungerp, the first fourth-generation antifungal drug with a novel mechanism of action in more than 20 years , was approved by the FDA in June 2021 for the treatment of fungal vaginitis
.
The drug, developed by SCYNEXIS in the United States, has broad-spectrum antifungal activity and can be used to treat nosocomial and nosocomial infections caused by a variety of fungi
.
Under the license agreement signed with SCYNEXIS in February 2021, Hansoh Pharma will be responsible for the development, regulatory approval and commercialization of Ibrexafungerp in China for a $10 million down payment plus potential milestone payments and royalties
.

Ibrexafungerp is the first fourth-generation antifungal drug with a novel mechanism of action in over 20 years

Overview of Ibrexafungerp's domestic projects

From: Insight Database Project Progress Module (http://db.
dxy.
cn/v5/home/)

KER-050, consisting of a modified ligand-binding region of the TGF-β receptor fused to the Fc region of a human antibody , is in clinical development for patients with myelodysplastic syndromes and myelofibrosis with cytopenias (including anemia) and thrombocytopenia)
.
According to the Insight database, the drug is currently in clinical phase II in its highest global status, and has not yet started clinical trials in China
.

KER-050 is composed of a modified TGF-β receptor ligand binding region fused to the Fc region of a human antibody

KER-050 Global R&D Progress Gantt Chart

From: Global New Drug Module of Insight Database (http://db.
dxy.
cn/v5/home/)

In terms of technology platforms, Hansoh Pharma focused on the RNA interference technology platform last year and reached two consecutive cooperations in this field, with Olix Pharmaceuticals and Silence Therapeutics respectively
.

In terms of technology platforms, Hansoh Pharma focused on the RNA interference technology platform last year and reached two consecutive cooperations in this field, with Olix Pharmaceuticals and Silence Therapeutics respectively
.

The collaboration between Hansoh Pharma and Olix was concluded in October 2021
.
Under the collaboration agreement, both parties will utilize Olix's GalNAc-asiRNA platform to discover lead drugs and secure drug candidate development against targets in liver-related cardiovascular, metabolic and other diseases , which Hansen owns in China, including Hong Kong , Macau and Taiwan), and Olix will have rights in other countries and regions outside of China
.
The transaction value includes an upfront payment of $6.
5 million and royalties based on key milestones of up to more than $450 million
.

The collaboration between Hansoh Pharma and Olix was concluded in October 2021
.
Targets of the GalNAc-asiRNA platform in liver-related cardiovascular, metabolic and other diseases

In the same month, Hansoh Pharma made another move, announcing an exclusive licensing collaboration agreement with Silence Therapeutics to leverage Silence Therapeutics' exclusive mRNAi GOLD platform to collaborate on the development of siRNA against three targets
.
For the first two targets, upon completion of Phase 1 clinical studies, Hansson will have an exclusive option to license in China (including Hong Kong, Macau and Taiwan), while Silence Therapeutics will have exclusive rights in other countries and regions outside of China ; For the third target, Hansson will obtain the exclusive option to license the global rights at the time of IND filing, and will be responsible for all development activities after the third target option is exercised
.
The total deal includes an upfront payment of $16 million + development, regulatory and commercial milestone payments of up to $1.
3 billion

In the same month, Hansoh Pharma made another move, announcing an exclusive licensing collaboration agreement with Silence Therapeutics to leverage Silence Therapeutics' exclusive mRNAi GOLD platform