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2022 license-out! The new drugs developed by more than 10 Chinese companies have successfully achieved overseas authorization!

 Last Update: 2023-01-01
 Source: Internet
 Author: User

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2022 is coming to an end
.
In the field of innovative drug research and development, under the general trend of global cooperation, the licensing cooperation in the field of innovative drugs in China will remain active and show new characteristics
in 2022.
This article will take stock and share more than 10 representative "license-out" cases that have successfully licensed new drugs or technologies overseas in the past year
.

From the perspective of disease fields, these products that have been authorized overseas are concentrated in the field of anti-tumor, followed by the fields
of metabolism, pain and autoimmune diseases.
From the perspective of cutting-edge technology and targets, these product types include monoclonal antibodies, dual antibodies, CAR-T cell therapies, antibody conjugates and targeted protein degraders, covering targets including TROP2, AR, Claudin 18.
2, BCMA, Siglec-15, IL-2, etc
.

In the field of anti-tumor, monoclonal antibody, bispecific antibody, CAR-T cell therapy, antibody conjugate drugs, and targeted protein degraders TROP2, AR, Claudin 18.
2、BCMA、Siglec-15、IL-2

This article will share some representative overseas licensing cooperation information in combination with public information for readers' reference

Licensed product: SIM0278

Mode of action: IL-2 mutant fusion protein

Authorized by: Simcere Pharmaceutical

Introduced by: Almirall

On September 29, Simcere Pharmaceuticals and Almirall announced that they have signed an exclusive licensing agreement
for the IL-2 mutant fusion protein SIM0278, an autoimmune candidate developed by the former.
Almirall will receive exclusive rights to develop and commercialize all indications of SIM0278 outside of Greater China, with Simcere receiving an upfront payment of $15 million and up to $492 million in development and commercial milestone payments
.

Autoimmune candidate IL-2 mutant fusion protein

SIM0278 is a subcutaneously administered Treg-selective interleukin-2 mutant fusion protein (IL-2 MU-FC), which is about to enter the clinical stage
.
It fuses IL-2 with specific mutations with the Fc terminal of the antibody, significantly extends the molecular half-life and improves receptor specificity and affinity, and can selectively activate Treg cells without activating effector T cells or NK cells, thereby restoring the body's immune balance, and is expected to be used in the treatment of a variety of autoimmune diseases
.

Subcutaneous administration of Treg-selective interleukin-2 mutated fusion protein (IL-2 mu-Fc）

Licensed product: JMKX002992

Mechanism of action: AR degrader

Authorized by: Jimin Credible

Introduced by: Genentech

On August 18, Jimin Credible announced that the Group and its subsidiary Shanghai Jiyu reached an exclusive license agreement with Roche and its Genentech, and Genentech obtained the exclusive right
to develop and commercialize JMKX002992, an oral androgen receptor (AR) degrader developed by Shanghai Jiyu Small Molecule Innovation Institute.
To this end, Genentech will make an upfront payment of $60 million and up to $590 million when the agreed milestones are reached
.

Oral androgen receptor (AR) degrader

JMKX002992 is a new oral AR degrader with therapeutic potential
for prostate cancer patients resistant to existing therapies.
It is worth mentioning that according to Roche's press release, this is also the first time that the company and its Genentech have obtained exclusive licensing rights
from a Chinese innovative pharmaceutical company to develop and commercialize potential drugs globally.

For the first time, the company and its Genentech have obtained exclusive licensing rights from a Chinese innovator to develop and commercialize potential drugs globally

Licensed product: SYSA1801

Mode of action: anti-Claudin 18.
2 antibody conjugate

Authorized by: CSPC Group

Introduced by: Elevation Oncology

On July 28, CSPC announced that its subsidiary, CSPC Jushi Biotechnology, has partnered with Elevation Oncology entered into an exclusive license agreement whereby CSPC Jushi Biologics agreed to grant the latter permission to develop and commercialize anti-Claudin outside of Greater China 18.
2 Exclusive rights
to antibody drug conjugate (ADC) SYSA1801.
CSPC will receive an upfront payment of $27 million and will be entitled to receive up to $148 million in potential development and regulatory milestone payments and up to $1.
02 billion in potential sales milestone payments
.

Anti-Claudin 18.
2 Potential sales milestone payments of up to $1.
02 billion for antibody drug conjugate (ADC) SYSA1801

The SYSA1801 is an ADC targeting Claudin 18.
2 that effectively passes anti-Claudin 18.
2 Antibodies target tumor cells and endocytosis, bringing small molecules of toxins into tumor cells and treating tumors
.
The drug has previously been granted orphan drug designation by the US FDA for the treatment of gastric cancer (including esophageal-gastric junction cancer) and pancreatic cancer, and is conducting a Phase 1 clinical study
in China.

Gastric cancer (including esophageal-gastric junction cancer) and pancreatic cancer

Authorized products: SKB-264, etc

Mechanism of action: ADC targeting TROP2, etc

Authorized by: Kolumbert

Introduced by: Merck

On July 26, Kelun Pharmaceutical's holding subsidiary, Kelun Botai, announced that it has reached a cooperation and exclusive license agreement with Merck Sharp & Dohme (MSD) for an ADC product for the treatment of solid tumors, and licensed Merck Sharp & Dohme to develop, manufacture and commercialize the product
worldwide.
The two companies will also collaborate
on the early clinical development of the ADC product.
Merck will make an upfront payment of $35 million, various milestone payments up to $901 million and a corresponding commission on net sales to Colombert
.

$35 million down payment for ADC products for the treatment of solid tumors, with various milestone payments up to $901 million

Earlier this year (May 16), Colombert signed an agreement with Merck to license SKB-264, an ADC product targeting TROP2, to Merck for commercial development
outside of Greater China for a fee.
Colombert will receive $17 million and $30 million, respectively, upon effective of the license agreement and upon the signing of the amendments to the agreement, respectively, with milestone payments not exceeding $1.
363 billion
.
SKB-264 is currently undergoing phase 2 and phase 3 clinical trials for single-agent/combination therapy for multiple tumor types, including an international multi-center phase 2 clinical study
in combination with anti-PD-1 monoclonal antibody pembrolizumab for the treatment of advanced solid tumors.

The cumulative amount of ADC products targeting TROP2 does not exceed US$ 1.
363 billion, and the combination of anti-PD-1 monoclonal antibody pembrolizumab in the treatment of advanced solid tumors is an international multicenter phase 2 clinical study

Licensed product: Liraglutide biosimilar

Mode of action: GLP-1 receptor agonist

Authorized by: Huadong Medicine

Introduced by: Julphar

On June 23, Huadong Pharmaceutical announced that its wholly-owned subsidiary, Hangzhou Sino-US East China, has reached a cooperation with Julphar to grant Julphar the right to develop, manufacture and commercialize its liraglutide injection biosimilar for diabetes and weight loss in 17 countries in the MENA region
.
Liraglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist
.
In China, Huadong Medicine has submitted a marketing application for this liraglutide injection to the China National Food and Drug Administration (NMPA), which is suitable for diabetes, obesity or overweight
.

Liraglutide injection biosimilars target glucagon-like peptide-1 (GLP-1) receptor agonists for diabetes and weight loss

Authorized products: rituximab biosimilars, etc

Mechanism of action: anti-CD20 monoclonal antibody, etc

Authorized by: Henlius

Introduced by: Eurofarma, Abbott, Organon

Henlius has reached at least 3 overseas licensing collaborations in 2022, including:

1) On May 11, Henlius announced that it has signed a license agreement with Eurofarma to develop, manufacture and commercialize three products: rituximab biosimilar (Hanlikang), trastuzumab biosimilar (Hanqu You) and bevacizumab biosimilar (Hanbeit) in 16 Latin American countries
.
Henlius will generate potential revenue of up to US$50.
5 million from the transaction;

Rituximab biosimilars (Hanlikang), trastuzumab biosimilars (Hanqu You), bevacizumab biosimilars (Hanbeitai) in 16 Latin American countries

2) On May 24, Henlius announced that it has signed a license agreement with Abbott to grant it semi-exclusive rights
in Brazil to commercialize its two products, Hanlikang and Hanquyou.
Abbott will make an upfront payment of $3 million and subsequent milestone payments up to $1.
4 million;

Hanlikang and Hanquyu

3) On June 13, Henlius announced that it has signed a licensing and supply agreement with Organon, granting the latter exclusive commercialization rights
to the two biosimilars HLX11 and denosumab biosimilar HLX14 outside China.
Henlius will generate potential revenue
of US$541 million.
According to Henlius, HLX11 and HLX14 are currently undergoing international multi-center Phase 3 clinical studies
.

Pertuzumab biosimilar HLX11, desnosumab biosimilar HLX14

Licensed product: JMKX000623

Mode of action: Nav1.
8 blocker

Authorized by: Jimin Credible

Introduced by: Orion corporation

On May 6, Jimin Credible announced that its subsidiary, Shanghai Jiyu, has entered into an exclusive cooperation agreement with Orion, which will acquire the development, production and commercialization rights
outside Greater China for JMKX000623, a new non-opioid analgesic drug independently developed by Shanghai Jiyu.
Shanghai Jiyu will receive an down payment of EUR 15 million and corresponding development and commercialization milestones
.
JMKX000623 is a highly selective and active Nav1.
8 blocker that blocks the onset and transmission of pain sensation by blocking sodium influx, and is expected to be developed for the treatment of acute and chronic pain
.
The drug has been approved for clinical use in China in March this year, and it is planned to develop the indication for pain
.

The new non-opioid analgesic drug JMKX000623 is a highly selective and active Nav1.
8 blocker

Licensed product: LM-302

Mode of action: ADC targeting Claudin 18.
2

Authorized by: Lixin Pharmaceutical

Introduced by: Turning Point

On May 5, Lixin Pharma announced an exclusive licensing agreement with Turning Point, which will be the exclusive partner to acquire Lixin Pharmaceutical's self-developed targeted Claudin 18.
2's development and commercialization rights
for the ADC product LM-302 in countries and regions around the world except Greater China and South Korea.
Lixin will receive an upfront payment of US$25 million, an R&D milestone payment of US$195 million and subsequent commercialization milestone payments, totaling more than US$1 billion
.

Target Claudin 18.
2 ADC products total more than $1 billion

According to public information, LM-302 has been approved for phase 1/2 clinical trials in China and the United States, and it has previously been granted orphan drug designation
by the FDA for the treatment of pancreatic, gastric and gastroesophageal junction cancer.
It is worth noting that in June this year, Bristol-Myers Squibb (BMS) has partnered with Turning Point reached an agreement to buy the latter
for more than $4 billion.

Licensed product: HBM7022

Mode of action: Claudin 18.
2 x CD3 bispecific antibody

Authorized by: Harbour Medicine

Introduced by: AstraZeneca

On April 7, Harbour Biopharma announced an authorized partnership
with AstraZeneca.
AstraZeneca will receive Claudin 18.
2x developed by Harbour Medicine Exclusive worldwide license for the development, registration, manufacturing and commercialization of the CD3 bispecific antibody HBM7022, and responsible for all costs
associated with the further preclinical development and commercialization of the drug.
Harbour BioMed will receive an upfront payment of $25 million and a milestone payment
of up to $325 million.

Claudin 18.
2 x CD3 bispecific antibody

HBM7022 is a new bispecific antibody that uses bivalent high affinity against Claudin The structure of 18.
2 and monovalent low-affinity anti-CD3 reduces the risk of
cytokine storm generation while ensuring high killing activity.
Preclinical studies have shown that the drug not only has a good effect on CLDN18.
2-positive gastric cancer, but also has a good effect on pancreatic cancer and CLDN18.
2 mutation
gastric cancer.

Licensed product: GFH009

Mode of action: CDK9 inhibitor

Authorized by: GenFleet

Introduced by: SELLAS Life Sciences Group

On April 1, GenFleet and SELLAS Life Sciences announced an exclusive licensing agreement to acquire global development and commercialization rights for GenFleet's new generation of highly selective CDK9 small molecule inhibitor GFH009 injections outside of Greater China
.
GenFleet will receive an upfront payment of US$10 million and technology transfer fees, as well as US$48 million in development milestone payments based on up to 3 indications and US$92 million in cumulative sales milestone payments
.

A new generation of highly selective CDK9 small molecule inhibitors

GenFleet's Phase 1 clinical trial
of GFH009 in patients with relapsed/refractory haematological malignancies has been conducted in China and the United States.
Preclinical experimental data showed that the selective inhibition rate of CDK9 protein by this product exceeded that of other CDK isoforms by more than
100 times.
SELLAS will conduct a GFH009 single-agent phase 1/2 basket trial
in pediatric patients with soft tissue sarcomas, including Ewing sarcoma and rhabdomyosarcoma.

Soft tissue sarcomas in children (including Ewing sarcoma and rhabdomyosarcoma)

Authorized product: PRG-1801

Mode of action: CAR-T cell therapy targeting BCMA

Authorized by: Pregin Biologics

Introduced by: CellPoint

On April 1, Prijin Biologics announced that it has reached a licensing cooperation with CellPoint to grant the European
and American rights of its self-developed BCMA-targeting CAR-T cell injection PRG-1801 for hematological tumor indications.
Prigin Biologics will receive an upfront payment of more than 20 million euros as well as milestone payments
at all stages.

BCMA-targeting CAR-T cell injection for hematological tumor indications

PRG-1801 has good safety and efficacy in chimeric heavy chain variable domains with high affinity and high specificity
.
It is worth mentioning that in June 2022, CellPoint was wholly acquired by Galapagos; In September, Pregin Biologics announced a further collaboration
with Galapagos regarding clinical development and commercialization rights for the PRG-1801 program in markets outside of China and India.

Licensed product: BSI-060T

Mode of action: anti-Siglec-15 antibody

Authorized by: Biosion Biosion

Introduced by: Pyxis Oncology

On March 30, Biosion announced a partnership with Pyxis Oncology entered into a licensing agreement to receive an exclusive license for the global development and commercialization of Biosion's innovative antibody BSI-060T outside of Greater China, and Biosion will receive a down payment of $10 million and will be eligible to receive milestone payments
totaling up to $222.
5 million.

BSI-060T (now known as PYX-106) is a high-affinity fully human antioxidant Siglec-15 (S15) monoclonal antibody is intended to be developed for the treatment of a variety of solid tumors
.
It blocks S15-induced immunosuppression
by targeting M2 macrophages, S15-induced bone marrow cells, and S15-positive tumors.
According to the protocol, Pyxis Oncology plans to commence clinical trial filings and Phase 1 clinical trials in the U.
S.
as soon as possible, and will have the opportunity to introduce next-generation product rights
around the Siglec-15 target from Biosion.

High affinity of the whole human resistance Siglec-15 (S15) monoclonal antibody

Licensed product: Ebergerstim α

Mode of action: long-acting granulocyte colony-stimulating factor

Authorized by: Yiyi Biotechnology

Introduced by: APOGEPHA

On February 28, Yifan Pharma announced that its subsidiary Yiyi Biotech signed a cooperation agreement with APOGEPHA, which will obtain the exclusive distribution rights
of Ebergastim α of long-acting granulocyte colony-stimulating factor (G-CSF) developed by Yiyi Biologics in Germany.
Yiyi Biologics will receive an upfront payment of US$400,000, a maximum development milestone payment of US$1 million and a sales milestone payment
of up to US$37.
5 million.
According to the public information of Yifan Pharmaceutical, ebegglastine α injection is intended to be used for the treatment of chemotherapy-induced neutropenia (CIN), and the drug has been submitted for marketing in China, the United States and the European Union and accepted
.

Long-acting granulocyte colony-stimulating factor (G-CSF) chemotherapy for neutropenia (CIN)

Licensed product: 609A

Mode of action: anti-PD-1 monoclonal antibody

Authorized by: 3SBio

Introduced by: Syncromune

On January 4, 3SBio announced that its subsidiary Sunshine Guojian signed a licensing agreement to license the global rights of its anti-PD-1 monoclonal antibody 609A for a combination tumor immunotherapy called syncrovax to Syncromune, and Sunshine Guojian will continue to maintain the rights and interests
of 609A outside of any syncrovax therapy worldwide 。 According to the press release of 3SBio, SYNCROVAX therapy is a personalized autologous vaccine platform that is committed to solving the limitations of current systemic immunotherapy by overcoming the immunosuppressive properties of metastatic cancer, so as to achieve the therapeutic purpose
of a variety of solid tumors.

Anti-PD-1 monoclonal antibody 609A is used in a personalized autologous vaccine platform for tumor immunotherapy combination therapies called syncrovax, which aims to address the limitations of current systemic immunotherapies by overcoming the immunosuppressive properties of metastatic cancer

In addition to the above-mentioned drugs, there are also some Chinese companies that have reached overseas licensing cooperation
on self-developed innovation platforms and technologies.
As:

In addition to the above-mentioned drugs, there are also some Chinese companies that have reached overseas licensing cooperation
on self-developed innovation platforms and technologies.

On January 11, Reindeer Biologics and Innovent Biologics jointly announced the award of Sana Biotechnology's clinically validated fully human BCMA CAR Non-exclusive commercial rights to structures for Sana's specific in vivo gene therapy and in vitro low immunocytotherapy product development;

Clinically proven, fully human BCMA CAR structure

On January 18, Abbisko and Eli Lilly and Company Company announced that it will collaborate on the discovery, development and potential commercialization of novel small molecule drugs for undisclosed targets in major diseases such as cardiometabolic diseases, and Abbisko will be responsible for further the discovery and development of small molecule drugs using its proprietary drug discovery and development platform;

Undisclosed targets in major diseases such as cardiometabolic diseases

On March 2, Tianyan Pharmaceutical announced that it has reached a research cooperation and exclusive technology licensing agreement with Sanofi to develop a new generation of precision-masked safe antibodies for monoclonal and dual antibodies provided by Sanofi using safe antibody SAFEbody technology;

Safe antibody SAFEbody technology is a new generation of precision masking safety antibodies for monoclonal and dual antibodies

On November 9, Insilico (Insilico Medicine) announced a strategic research and development alliance
with Sanofi.
The two companies will leverage Insilico's AI platform Pharma.
AI to develop drug candidates for up to six new targets;

Artificial intelligence platform Pharma.
AI

On November 11, Harbour Biopharma announced that its wholly-owned subsidiary, Nona Biologics, signed a licensing and cooperation agreement with Moderna to make full use of Harbour Biopharma's proprietary fully human heavy-chain antibody platform HCAb to research and develop gene immunotherapies
.

Fully human heavy chain antibody platform HCAb

In addition to the above cases, some new drugs and technologies developed by Chinese companies have also reached authorized cooperation in 2022.

We are glad to see that different forms, different fields and even interdisciplinary cooperation in the field of innovative drug research and development are constantly emerging, and collaborative innovation has become the new normal in the industry
.
Through the collision of learning from the strengths and innovations, new technologies and new therapies are coming to patients with an "acceleration" trajectory
.
It is hoped that the follow-up development process of these new drugs will proceed smoothly and benefit patients around the world as soon as possible!

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