In November, Hengrui Medicine, Zai Lab, Livzon Group, etc. reached new drug authorization cooperation

TextPharmaceutical Guanlan

New drug transactions are one of the important ways for biopharmaceutical companies to rapidly expand their product pipelines, develop more innovative combination therapies, and rapidly commercialize innovative products

In addition, Zai Lab, Enhua Pharmaceutical, Xianweida Biological and others have "license-in" innovative therapies from overseas this month, while Luye Pharma and Livzon Group have realized the "license-out" of innovative drugs to overseas companies

1.

Licensee: Suzhou Corning Jereh

Drug mechanism of action: anti-PD-L monoclonal antibody

On November 8, Ascletis and Suzhou Corning Jerry announced that they have reached an exclusive global development agreement for ASC22 (envolimab, also known as KN035) to treat all viral diseases including hepatitis B outside of Greater China

2.

Authorized by: Tianjing Biological

Drug mechanism of action: long-acting recombinant human growth hormone (rhGH)

On November 10, Jichuan Pharmaceutical and Tianjing Biological reached a strategic cooperation on the latter's long-acting recombinant human growth hormone, itan growth hormone

3.

Licensee: CStone Pharmaceuticals

Drug mechanism of action: anti-CTLA-4 monoclonal antibody

On November 22, Hengrui Medicine and CStone Pharmaceuticals reached an agreement to obtain the exclusive rights to develop, register, manufacture and commercialize the latter's anti-CTLA-4 mAb CS1002 in Greater China

4.

Licensor: Connoya Biological

Drug mechanism of action: anti-TSLP monoclonal antibody

On November 22, Connoya Bio and CSPC exclusively authorized the development and commercialization of the former anti-glandular stromal lymphopoietin (TSLP) monoclonal antibody CM326 in moderate to severe asthma and chronic obstructive pulmonary disease (COPD) and other respiratory diseases.

5.

Authorized Party: Jimin Trust

Drug mechanism of action: KRAS inhibitors

On November 30, Jimin Trust announced that it has reached an exclusive license agreement with Huya Bio International for the KRAS inhibitor JMKX1899

Drug development targeting oncogenic mutations in KRAS is currently a hot topic

6.

Licensor: Phagelux Skin Sciences

Drug mechanism of action: phage lyase

On November 4, Shanghai Pharmaceuticals announced that it has obtained the rights and interests authorization of the ClyO project of Figeloc's new anti-bacterial infection drug in mainland China, Hong Kong and Macau

7.

Licensors: Blueprint Medicines, Karuna Therapeutics

Drug mechanism of action: EGFR inhibitors, oral M1/M4 muscarinic agonists

On November 9, Zai Lab announced two exclusive "license-in" licensing agreements
.
One is the development and commercialization of BLU-945 and BLU-701, a new generation of epidermal growth factor receptor (EGFR) non-covalent tyrosine kinase inhibitors developed by Blueprint in Greater China
.
The prepayment for this partnership is $25 million
.
According to the press release, BLU-945 and BLU-701, derived from Blueprint's proprietary research platform, are designed to provide comprehensive coverage of the most common activating and targeted resistance mutations, bypassing wild-type EGFR and other kinases to reduce off-target toxicity, while simultaneously A range of combination strategies can be achieved and treat or prevent CNS metastases
.

Another drug candidate, KarXT, is being developed, manufactured and commercialized by Karuna for Greater China
.
The partnership is $35 million upfront
.
KarXT is an oral M1/M4 muscarinic agonist in Phase 3 studies that activates receptors in the central nervous system associated with various psychiatric disorders
.
KarXT currently has four ongoing Phase 3 clinical studies, with two EMERGENT-2 and EMERGENT-3 studies evaluating efficacy in the acute phase of schizophrenia expected to have data in 2022
.

8.
Introducing party: Enhua Pharmaceutical

Licensor: Lundbeck Company

Drug mechanism of action: targeting dopamine receptors, serotonin receptors, and adrenergic receptors

On November 25, Nhwa Pharmaceuticals and Lundbeck reached an exclusive license for the development, production and commercialization of the latter's Lu AF35700, an oral small molecule drug for schizophrenia, in Greater China
.
According to a press release, LuAF35700, originally developed by Lundbeck for the treatment of refractory schizophrenia, targets dopamine receptors, serotonin receptors and adrenergic receptors, with a higher affinity for dopamine D1 receptors than D2 receptors , its unique pharmacological mechanism is expected to reduce the incidence of side effects such as extrapyramidal reactions and hyperprolactinemia
.
To date, several clinical trials (including Phase 3 pivotal clinical trials) have validated the safety and well-tolerated profile of Lu AF35700
.

9.
The importer: Xianweida Biology

Licensor: Sanofi

Drug mechanism of action: GIP receptor agonists

On November 30, Xianweida announced that it has reached an exclusive global license agreement with Sanofi for the latter's long-acting glucose-dependent insulin-stimulating polypeptide (GIP) receptor agonist project
.
The drug candidate is currently in preclinical development
.
According to the press release, GIP receptor agonists have the potential to further enhance the efficacy, overall safety and tolerability of glucagon-like peptide 1 (GLP-1) receptor agonists in the treatment of obesity and diabetes
.
Xianweida plans to advance as soon as possible the development of a drug combination treatment program of the GIP receptor agonist and its GLP-1 drug candidate XW003 in the pipeline.
XW003 is currently in phase 2 clinical research for diabetes, obesity and non-alcoholic fat.
Sexual Hepatitis (NASH) Treatment
.

10.
Importer: Zambon Switzerland

Licensee: Luye Pharma

Drug mechanism of action: Cholinesterase inhibitors

On November 10, Luye Pharma announced that it had granted Zambon Switzerland the exclusive commercialization rights for Ristigmine Transdermal Patch in Switzerland
.
This product is an innovative twice-weekly patch formulation of Ristigmine for the treatment of mild to moderate dementia associated with Alzheimer's disease, developed by Luye Pharma's proprietary transdermal drug delivery technology platform , has obtained marketing authorization in many European countries, and Luye Pharma will also apply for the marketing of this product in Switzerland
.
In China, the product has entered clinical trials
.

Ristigmine is a cholinesterase inhibitor class of drugs that improve cognitive functions such as memory and thinking by increasing the amount of certain natural substances in the brain and amplifying the communication channels between nerve cells
.
According to the press release, Luye Pharma's product is administered through the skin twice a week through an innovative route of administration, and the less frequent use can improve patients' medication compliance
.

11.
Importer: Bright Peak Therapeutics

Licensee: Livzon Group

Drug mechanism of action: anti-PD-1 monoclonal antibody

On November 17, Livzon Group announced that its subsidiary Livzon Mab and Bright Peak Therapeutics (BPTx) have reached a research cooperation and licensing agreement, and Livzon Mab will license its anti-PD-1 monoclonal antibody LZM009 to BPTx for a fee.
For the development of novel PD-1-targeted immune cytokines (PD-1 ICs), and to license LZM009 to BPTx for the development and commercialization of PD-1 ICs in territories other than Greater China
.

According to the press release, the PD-1 ICs will consist of an optimized cytokine payload developed by BPTx that selectively targets and activates toxic CD8+ T cells expressing PD-1, while avoiding extensive activation of other immune cells
.
This payload is used synergistically with LZM009 to treat various cancers
.

According to reports, BPTx is a biotechnology company developing next-generation cytokine immunotherapy.
Its unique chemical protein synthesis and engineering platform can precisely design cytokines to fine-tune receptor binding, optimize efficacy, and at the same time, the protein structure of cytokines The binding handle is inserted into any desired site to rapidly bind enhanced cytokines as payloads to antibodies to develop innovative immunocytokine therapeutics
.

We look forward to the smooth progress of follow-up research on these innovative therapies, bringing more and better treatment options to patients
.

References:

[1] Official websites and public press releases of each company