License-in inventory for the first quarter!

Source: Guanlan Pharmaceutical

Importing products from outside has become one of the important ways for pharmaceutical companies to expand their product pipelines.

1.

Authorized party: ImmuneOncia Therapeutics

Mechanism of drug action: anti-CD47 monoclonal antibody

On March 31st, Sidi Medicine announced that it has obtained the exclusive authorization for the development, production and commercialization of ImmuneOncia's new generation of anti-CD47 monoclonal antibody IMC-002 tumor indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan).

According to reports, IMC-002 is a new fully humanized IgG4 monoclonal antibody drug, which promotes the phagocytosis of tumor cells by macrophages by blocking the CD47-SIRPα interaction.

2.

Authorized party: Kazia Therapeutics

Mechanism of drug action: PI3K/mTOR pathway inhibitor

On March 29, Simcere and Kazia announced the signing of an exclusive license agreement.

Paxalisib is a PI3K/mTOR pathway inhibitor that can penetrate the blood-brain barrier and is currently undergoing global phase 2/3 GBM AGILE glioblastoma platform clinical trials.

3.

Authorized party: Daewoong Pharmaceuticals

Mechanism of drug action: new potassium ion competitive acid blocker drugs (P-CAB)

On March 18, Daxiong Pharmaceutical announced that it had signed a license agreement with Hainey Pharmaceutical, a subsidiary of Yangzijiang Pharmaceutical Group, authorizing the latter to develop and sell its gastroesophageal reflux treatment drug fexuprazan in China.

According to reports, fexuprazan is a new type of potassium ion competitive acid blocker drug developed by Daxiong Pharmaceutical, which has "best-in-class" potential.

4.

Authorized party: ReViral

Mechanism of drug action: an oral fusion inhibitor

On March 2, Liantuo and ReViral announced that they have reached an exclusive cooperation and licensing agreement.

Sisunatovir is an oral fusion inhibitor designed to block RSV replication by inhibiting F-mediated fusion of the virus with host cells.

5.

Authorized party: Boston Immune Technologies and Therapeutics (hereinafter referred to as "BITT")

Mechanism of drug action: TNFR2 antagonist antibody

On February 18, BITT and BeiGene announced a selection and licensing agreement to develop and commercialize BITT's innovative tumor necrosis factor (TNF) receptor type 2 (TNFR2) antagonist antibody BITR2101.

TNFR2 is a member of the TNF receptor superfamily.

6.
Introducer: Huadong Medicine

Authorized party: Provention Bio

Mechanism of drug action: CD32b/CD79b bispecific antibody

On February 18, Sino-US Huadong, a wholly-owned subsidiary of Huadong Medicine, reached an agreement with Provention Bio.
According to the agreement, Sino-US East China obtained the exclusive clinical development and commercialization rights of the latter's research bispecific antibody PRV-3279 for two clinical indications in Greater China.
Provention Bio will receive a down payment of US$6 million, R&D and production support funding of US$11.
5 million, a milestone payment of up to US$172 million, and a net sales commission fee.

PRV-3279 is a humanized bispecific antibody that targets B cell surface proteins CD32b and CD79b.
Pre-clinical and clinical trials have shown that PRV-3279 can inhibit B cell function and the production of autoantibodies, but does not cause B cell exhaustion and is well tolerated.
PRV-3279 has the potential to treat B cell-mediated autoimmune diseases and prevent or reduce the immunogenicity of biological treatments.
PRV-3279 is currently being tested in the United States for systemic lupus erythematosus (SLE) and immunogenic indications for the prevention or reduction of gene therapy.

7.
Introduced party: Qilu Pharmaceutical

Authorized party: Cend Therapeutics

Mechanism of drug action: peptide

On February 16, Cend and Qilu Pharmaceutical announced that they had reached a cooperation agreement.
According to the agreement, Qilu Pharmaceuticals will obtain the exclusive right to develop and commercialize Cend's drug CEND-1 in Greater China.
Cend will receive a down payment of US$10 million and will be eligible for milestone payments of up to US$225 million, as well as corresponding royalties.

CEND-1, also known as iRGD, is a polypeptide that can bind to neuropilin.
Neuropilin is one of the highly expressed proteins on pancreatic cancer cells.
After it is combined with iRGD, it can mediate the endocytosis of cells and produce delivery vesicles.
These vesicles can transfer the anti-cancer drugs used with iRGD from the blood to the inside of the tumor tissue, thereby enhancing the killing effect of the anti-cancer drugs.
According to the data released by Cend at the 2020 ESMO conference: In a phase 1 clinical trial, the triple therapy of CEND-1 with gemcitabine and albumin paclitaxel achieved a 59% overall response rate in the treatment of patients with metastatic pancreatic cancer And a disease control rate of 83%.
At present, Cend is planning to conduct a registered clinical trial of CEND-1 for pancreatic cancer, and will explore the combination of the drug and other therapies.

8.
Introduced party: Nuance Pharma

Authorized party: Antibe Therapeutics

Mechanism of drug action: non-steroidal anti-inflammatory drugs

On February 9th, Antibe announced that it had reached a cooperation with Yourui Pharmaceuticals.
Yourui Pharmaceuticals will obtain exclusive agency rights to promote the commercialization of the latter's otenaproxesul (ATB-346) in the Greater China region.
According to the terms of the agreement, in addition to more than 10% of royalties, Antibe will receive a payment of US$100 million, including a first payment of US$20 million and a development and sales milestone payment of US$80 million.

According to reports, otenaproxesul is a new type of anti-inflammatory drug that can release hydrogen sulfide and has the potential to become a "best-in-class" non-steroidal anti-inflammatory drug.
In phase 2 clinical trials, otenaproxesul showed better gastrointestinal safety advantages, as well as significant osteoarthritis analgesia.
According to the press release, researchers expect to launch a global multi-arm Phase 3 key trial of otenaproxesul for osteoarthritis analgesia in 2021, and will also launch other clinical trials for chronic pain indications.

9.
Introducer: Kewang Pharmaceutical

Authorized party: TRIGR Therapeutics

Mechanism of drug action: VEGF/DLL4 bispecific antibody

On January 21, Kewang Pharmaceutical and TRIGR announced that they have reached an exclusive license agreement in Greater China for the anti-angiogenic dual-antibody drug TR009 (ES104).
According to the agreement, Kewang Pharmaceutical will obtain the exclusive right to develop and commercialize ES104 in the Greater China region.
TRIGR will receive a down payment of US$7 million, a development and commercialization milestone payment of up to US$110 million, and royalties after the ES104 goes public.

TR009 is a bispecific antibody that simultaneously blocks VEGF/DLL4, and a single-chain variable region antibody targeting DLL4 is linked to the target VEGF antibody at the main end.
According to a press release issued by Kewang Medical, TR009 is undergoing phase 1 clinical single-dose ramping and expansion and combination therapy.
The results of clinical studies show that TR009 monotherapy has observed sustained PR responses in many patients with colorectal cancer and gastric cancer who have previously received 3-line and above treatments and failed multi-line treatments, and achieved 67% of clinical trials overall.
Yield rate.

10.
Introducer: Fuhong Henlius

Authorized party: Chiome Bioscience

Mechanism of drug action: anti-TROP2 antibody

On January 14, Henlius Group announced that it had signed an exclusive license agreement with Chiome, obtaining the latter’s exclusive rights and project background intellectual property rights for the research, development, production and commercialization of the latter’s anti-TROP2 antibody project in China.
The right to transfer the project to a third party.
At the same time, Chiome also granted Fuhong Henlius the first option to exclusively develop, produce and commercialize the project in other parts of the world.
According to the agreement, Chiome will receive a down payment of US$1 million, development milestone payments of no more than US$23 million, commercial milestone payments of no more than US$86.
5 million, and royalties based on annual net sales.

TROP2 is a class of biomarkers first discovered on the surface of invasive trophoblast cells.
Studies have shown that it can play a regulatory function in cell proliferation and migration, self-renewal and maintenance of basement membrane integrity.
A large number of research results show that, relative to the expression level in normal cells, TROP2 is highly expressed in many different types of human tumors, and it plays an important role in tumorigenesis, development and invasion.
Preclinical studies have shown that antibodies targeting TROP2 can effectively inhibit the growth of a variety of tumor cells in animal cancer models, and exhibit synergistic effects with a variety of anti-tumor therapies.

11.
Introducing party: BeiGene

Authorized party: Strand Therapeutics

Mechanism of drug action: mRNA therapy

On January 11, Strand and BeiGene jointly announced that the two parties have reached a cooperation on the development and commercialization of Strand's new, multifunctional mRNA therapy in solid tumors.
BeiGene has obtained the right to develop and commercialize up to two tumor immunity projects in Asia (except Japan), Australia and New Zealand.
These projects will use Strand’s intratumoral or systemic delivery mechanism and will have the ability to change tumor micro The environmentally capable mRNA is directly delivered to the tumor lesion.
According to the agreement, Strand will receive an advance payment of US$5 million, totaling up to US$28 million in additional recent payments.
After reaching certain milestones, Strand is also eligible to receive up to $277 million in payments, plus product sales royalties.

According to reports, Strand has completed the development of its first technology platform for the production of programmable and long-acting mRNA therapies that can deliver multifunctional treatments in the field of major diseases.
The platform will be initially used to develop promising therapeutic entities.
Tumor therapy.
The mRNA therapy developed by Strand has the characteristics of self-replication, and the precise control of the location, event, intensity and duration of protein expression is achieved through bioengineering design, thereby improving efficacy and reducing toxicity.

12.
Introducer: Zai Lab

Authorized party: Turning Point Therapeutics

Mechanism of drug action: MET/SRC/CSF1R inhibitor

On January 11, Zai Lab and Turning Point announced that the two parties would further deepen their strategic cooperation.
According to the terms of the agreement, Zai Lab will obtain the exclusive right to develop and commercialize the MET/SRC/CSF1R inhibitor TPX-0022 in Greater China.
Turning Point will receive a cash advance of US$25 million, a milestone payment of up to US$336 million in potential development, registration and sales, and royalties based on annual net sales.

According to reports, TPX-0022 is an oral multi-target kinase inhibitor.
Its brand-new macrocyclic structure can inhibit target mutations in MET, CSF1R and SRC genes.
The drug has been approved for a new drug clinical application in the United States, and a phase 1 clinical study for patients with advanced or metastatic solid tumors with MET/HGF or CSF1R/SCF1R mutations was initiated in the second half of 2019.

13.
Introducer: Zai Lab

Authorized party: argenx

Mechanism of drug action: Therapies targeting FcRn

On January 6, Zai Lab and argenx announced that they have reached an exclusive licensing cooperation.
According to the terms of the agreement, Zai Lab will obtain the exclusive right to develop and commercialize efgartigimod in Greater China, and will be responsible for the global registration and clinical research and development of multiple indications of the candidate drug in China.
In addition, Zai Lab will also be responsible for initiating phase 2 confirmatory studies for multiple new indications in Greater China to accelerate the development of more autoimmune indications for efgartigimod on a global scale.
argenx will receive a total of 175 million US dollars in cooperation payments, including an advance payment of 75 million US dollars.

Efgartigimod is an antibody fragment under development, designed to reduce pathogenic immunoglobulin G (IgG) antibodies and block IgG circulation.
Efgartigimod can bind to FcRn, which is widely expressed throughout the body and plays a central role in preventing the degradation of IgG antibodies.
Blocking FcRn can reduce the expression level of IgG antibodies, thereby treating autoimmune diseases that are known to be driven by pathogenic IgG antibodies, including myasthenia gravis, vulgaris