Over 4 billion U.S. dollars!

In August 2021, according to incomplete statistics, a total of 8 license in transactions and 4 license out transactions occurred in domestic pharmaceutical companies.
The total disclosed transaction amount exceeded 4 billion U.
S.
dollars, and the license out transaction amount was as high as 3.
41 billion U.
S.
dollars, a new history.
Record
.

Among them, Rongchang Biotechnology obtained US$2.
6 billion in revenue through the license out of vedicitumumab, which became the largest transaction this month, and also set the highest record of overseas authorized transactions for a single species of Chinese pharmaceutical companies
.

In recent years, with the continued popularity of license out transactions, this signal is also considered an important sign that domestic innovative pharmaceutical companies have begun to internationalize

In addition, CSPC completed 2 transactions this month, which accounted for the largest number of transactions, and involved both introduction and export
.

In August 2021, domestic pharmaceutical companies license in/out transactions, drawing by Shell Club

The following is the details of the license in/out transactions of domestic pharmaceutical companies in August:

1.
license in

1.
license in

Drug name: OC-01, OC-02

Drug name:

Authorized party: Oyster Point Pharma

Authorized party:

Introducer: Jixing Pharmaceutical

Introducing party:

On August 6, Jixing Pharmaceuticals announced that it had reached a cooperation license agreement with Oyster Point Pharma.
Jixing Pharmaceuticals obtained the development and commercialization of OC-01 (varenicline) for the treatment of dry eye (DED) symptoms and signs in Greater China.
) And OC-02 (simpinicline) nasal spray exclusive rights
.

According to the agreement, Oyster Point Pharma can receive a cash down payment of US$17.
5 million and up to 0.
75% of Jixing Pharmaceutical's shares, half of which are subject to pre-specified vesting conditions
.

In addition, they are also eligible for milestone payments of up to 204.

It is reported that OC-01 (varenicline) nasal spray is a multi-dose packaged, preservative-free, highly selective cholinergic agonist nasal spray, used to treat the symptoms and signs of dry eye and neurotrophic keratopathy
.

In December 2020, Oyster Point Pharma has submitted a new drug marketing application for OC-01 (varenicline) nasal spray to the FDA for the treatment of symptoms and signs of dry eye

OC-01 (varenicline) nasal spray is a multi-dose packaged, preservative-free highly selective cholinergic agonist nasal spray.

Drug name:

Authorized party: Epizyme

Authorized party:

Introducer: Hutchison Medicine

Introducing party:

On August 9, Hutchison Pharmaceuticals announced that it has reached a cooperation with Epizyme to conduct research, development, production and commercialization of TAZVERIK in Greater China (including China, Hong Kong, Macau and Taiwan)
.

According to the agreement, Epizyme can receive a down payment of US$25 million and is eligible to receive an additional development and regulatory milestone payment of no more than US$110 million (covering up to eight other potential indications) and a sales milestone payment of no more than US$175 million
.

Epizyme is also eligible to receive royalties ranging from the median of 10% to the low digits of 20% based on TAZVERIK's annual net sales in Greater China

It is reported that TAZVERIK is an EZH2 methyltransferase inhibitor developed by Epizyme.
By inhibiting EZH2, it regulates the transcription of genes involved in cell cycle regulation and terminal differentiation, thereby inhibiting tumor cell proliferation
.

At present, the drug has been approved by the FDA for use in adult and pediatric patients 16 years and older with metastatic or locally advanced epithelial sarcoma, and adult patients with relapsed or refractory follicular lymphoma, and their tumors have been FDA-approved trials He tested positive for EZH2 mutation and had received at least two systemic treatments before

By inhibiting EZH2.

Drug name:

Authorized party: Incyte

Authorized party:

Introducer: Nuocheng Jianhua

Introducing party:

On August 17, Nuocheng Jianhua announced that Tafasitamab and Incyte had reached a cooperation and licensing agreement in Greater China.
Nuocheng Jianhua obtained Tafasitamab in the Greater China Region (Mainland China, Hong Kong, Macau and Taiwan) for hematoma and solid tumors.
Domain development and exclusive commercialization rights
.

According to the agreement, Incyte will receive an upfront payment of US$35 million and is eligible for potential development, registration and commercialization milestone payments of up to US$82.
5 million, as well as a tiered sales share
.

It is reported that Tafasitamab is a humanized monoclonal antibody targeting CD19, which significantly strengthens antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) by optimizing the Fc domain .
Thus, the lysis of B-cell tumors is mediated by apoptosis and immune effect mechanisms
.

Tafasitamab has received accelerated FDA approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide, including DLBCL evolved from low-malignant lymphoma, and non-autologous Patients with stem cell transplantation (ASCT) conditions

Significantly enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) by optimizing the Fc domain

Drug name : KN026

Drug name

Authorized party: Corning Jerry

Authorized party:

Introduced party: CSPC

Introducing party:

On August 23, CSPC and Corning Jereh reached a cooperation agreement, and CSPC obtained the exclusive development and commercialization authorization of Corning Jereh HER2 dual-antibody KN026 in the fields of breast and gastric cancer
.

According to the agreement, Corning Jereh will receive an advance payment of 150 million yuan, a development milestone of 450 million yuan and a sales milestone of 400 million yuan
.

In addition, it will receive a double-digit sales share

It is reported that KN026 is a bispecific antibody drug targeting HER2 with independent intellectual property rights developed by Corning Jereh.
It can bind to two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade , which is more effective than trastuzumab.
Or Pertuzumab is used alone, and achieves the combined effect of trastuzumab and Pertuzumab, such as showing higher affinity and having superior tumor suppression effect in HER2-positive tumor cell lines
.

Can bind to two non-overlapping epitopes of HER2 at the same time, leading to blockade of HER2 signaling

At present, KN026 is conducting multiple phase I/II clinical studies simultaneously in China and the United States to evaluate the treatment of HER2-low expression or HER2-positive breast cancer, advanced HER2-positive gastric cancer, gastroesophageal junction cancer and other HER2-positive solid tumors and other indications Potential
.

Drug name: Pranabrin

Drug name:

Authorized party: Wanchun Bulin

Authorized party:

Introducer: Hengrui Medicine

Introducing party:

On August 26, Hengrui Pharmaceuticals announced that it has established a partnership with Dalian Wanchunbulin Pharmaceutical Co.
, Ltd.
The region's exclusive commercialization, clinical development and equity investment reached a major strategic cooperation
.

According to the agreement, Wanchun Bulin can receive a down payment of 200 million yuan, and will not exceed 1.
1 billion yuan in expenses when the corresponding R&D milestones and commercialization milestones are reached
.
In addition, it will also receive an equity investment of RMB 100 million from Hengrui Pharmaceuticals
.

It is reported that Pranabrin is the world's first immune small molecule drug that stimulates the maturation of dendritic cells and enhances antigen presentation.
It is expected to become a new cornerstone of immunotherapy other than anti-PD-1/L1 antibodies
.
In addition, the combination regimen of Pranabrin, anti-PD-1 antibody and other immune drugs has been carried out in early clinical trials on 7 solid tumors
.
In the phase I study of second and third-line small cell lung cancer, the combination therapy has achieved significant anti-tumor effects regardless of whether the patient has received anti-PD-1 monoclonal antibody and other immune checkpoint inhibitors in the early stage
.

Pranabrin is the world's first immune small molecule drug that stimulates the maturation of dendritic cells and enhances antigen presentation.

Drug name : JBPOS0101

Drug name

Authorized party : B-PS

Authorized party

Introducer: Jingxin Pharmaceutical

Introducing party:

On August 26, Jingxin Pharmaceutical announced that it had signed a new drug cooperation agreement with South Korea's Bio-Pharm Solutions Co.
Ltd.
(B-PS)
.
Jingxin Pharmaceutical obtained the exclusive clinical R&D, production and commercialization rights of two clinical indications (infantile spasm, focal epilepsy) of B-PS company's research product JBPOS0101 in mainland China (including Hong Kong, China and Macau, China)
.

According to the agreement, B-PS can obtain a down payment of USD 5 million, a milestone payment of up to USD 35 million, and royalties based on the total product sales
.

It is reported that JBPOS0101 reduces neuronal firing by binding to metabotropic glutamate receptors.
It is a "first-in-class" product.
Currently, there is no drug with the same target on the market worldwide.
JBPOS0101 is
listed in the Red Book of the National Institutes of Health.
It is the most potential epilepsy drug .
Preclinical studies have shown that JBPOS0101 is safe and effective for a variety of animal models of epilepsy.
At the same time, clinical data have shown that JBPOS0101 can effectively control infantile spasms and photosensitive seizures (usually used as a proof-of-concept test for focal epilepsy)
.

JBPOS0101 is listed as the most potential epilepsy drug by the National Institutes of Health Red Book
.

Drug name: ISAC drug candidate

Drug name:

Authorized party: Bolt

Authorized party:

Introducer: Xinda Biological

Introducing party:

On August 27, Innovent announced that it has reached an agreement with Bolt to jointly develop three antibody-immunostimulatory conjugate (ISAC) drug candidates for the treatment of tumors
.
Cinda Bio will have the rights to the Greater China region of the three cooperative projects, while retaining the global rights of one of the projects, and the right to choose the rights of the other project except North America
.

According to the agreement, Bolt can obtain a cash down payment of 5 million U.
S.
dollars and a potential future equity investment of no more than 10 million U.
S.
dollars
.
In addition, after reaching development and sales milestones in their respective regions, both companies are eligible to receive corresponding milestone payments and royalties
.

It is reported that Bolt’s proprietary Boltbody™ platform is composed of antibody-immunostimulatory conjugates (ISAC), which activates myeloid cells to enhance the adaptive immune tumor killing response, transform cold tumors into immunologically hot tumors, and expose tumors In the immune system, it is then processed by tumor killer cells
.

By activating myeloid cells, the adaptive immune tumor-killing response is enhanced,

Drug name: F-627

Drug name:

Authorized party : Yiyi Bio

Authorized party :

Introducer: Zhengda Tianqing

Introducing party:

On August 30, Chia Tai Tianqing announced that it has signed a new biological drug F-627 (Aibeguestine α, long-acting G-CSF) with Yiyi Bio for the treatment of chemotherapy-induced neutropenia (CIN).
China's exclusive strategic cooperation agreement
.

According to the agreement, Yiyi Bio will receive up to 210 million yuan in down payment and milestone payments, as well as double-digit tiered net sales royalties
.

It is reported that F-627 is a recombinant fusion protein in the form of a homodimer, in which two G-CSF-Fc molecules are covalently linked by a disulfide bond formed between the Fc fragments of the molecule
.
Through specific binding to its G-CSF receptor, F-627 can stimulate the survival, proliferation, differentiation and function of neutrophil precursors and mature neutrophils, aiming to treat cancer patients with neutrality after chemotherapy Granulocytopenia (CIN)
.

F-627 is a recombinant fusion protein that exists as a homodimer.

Two.
license out

Two.
license out

Drug name: Vidicuzumab

Drug name:

Authorized party: Rongchang Biological

Authorized party:

Introducer: Seattle Gene

Introducing party:

On August 8, Rongchang Biotechnology and Seagen Inc.
reached an exclusive global license agreement to develop and commercialize its new ADC drug, vedicitumumab
.
Seattle Genes has obtained the global development and commercialization rights of Vidicuzumab outside the Rongchang Bioregion, and Rongchang Bio will retain the right to carry out clinical development and commercialization in the Asian region (except Japan and Singapore)
.

According to the agreement, Rongchang Bio will receive a down payment of US$200 million and a milestone payment of up to US$2.
4 billion
.
In addition, Rongchang Bio will obtain a gradient sales commission from the high single-digit to more than ten percent of the net sales of Vidicuzumab in the Seattle gene-licensed area
.

It is reported that Vidicuzumab is a new ADC drug targeting HER2 with high affinity for HER2 and endocytosis efficiency
.
In June of this year, the drug has been conditionally approved by NMPA, becoming the first domestically-made ADC new drug for the treatment of locally advanced metastatic gastric cancer; recently, the official website of CDE showed that Rongchang Bio's vedicutumab for injection is planned to be included as a priority Review, for the treatment of locally advanced or metastatic urothelial cancer patients who have previously received systemic chemotherapy and whose HER2 expression is 2+ or 3+ by immunohistochemical examination.
This will be the second approved indication
.

Vidicuzumab is a new ADC drug targeting HER2 with high affinity for HER2 and endocytosis efficiency
.

Drug name: NBL-015

Drug name:

Authorized party: CSPC

Authorized party:

Introducer: Flame Biosciences

Introducing party:

On August 17, CSPC announced that its subsidiary NovaRock Biotherapeutics (NovaRock) has signed a cooperation license agreement with Flame Biosciences
.
NovaRock will grant Flame Biosciences the exclusive rights to develop, manufacture and commercialize its fully human anti-Claudin 18.
2 monoclonal antibody NBL-015 outside of Greater China (including China, Hong Kong, Macau and Taiwan)
.

According to the agreement, NovaRock can receive a down payment of US$7.
5 million, a development milestone payment of up to US$172.
5 million, and a sales milestone payment of up to US$460 million
.
In addition, it is also entitled to a certain percentage of the net sales of licensed products outside of Greater China
.

It is reported that NBL-015 is a fully human anti-Claudin 18.
2 monoclonal antibody that has been optimized by protein engineering and has enhanced ADCC, CDC and ADCP effects
.
In addition, preclinical studies have shown that NBL-015 has the potential advantages of low immunogenicity, high safety, strong affinity and high anti-tumor activity, and is expected to become a "best-in-class" targeted drug for the treatment of pancreatic cancer and gastric cancer
.
As of now, NBL-015 is in clinical development and has been granted orphan drug designation by the FDA for the treatment of pancreatic cancer and gastric cancer (including cancer of the esophagus-gastric junction)
.

NBL-015 is a fully human anti-Claudin 18.
2 monoclonal antibody, optimized by protein engineering, with enhanced ADCC, CDC and ADCP effects
.

Drug name: Procramide

Drug name:

Authorized party: Kaifeng Pharmaceutical

Authorized party:

Introducer: Etana

Introducing party:

On August 25th, Kaifeng Pharmaceutical announced that it has reached a commercial cooperation agreement with Etana Biotechnologies (Etana) in Indonesia for the treatment of prokulamide for the new crown
.

According to the agreement, Kaifeng Pharmaceutical will receive a certain down payment and milestone payment, and will also obtain economic benefits related to the sale of prokruamide in Indonesia
.

It is reported that procrulamide is a new generation of androgen receptor antagonist independently developed by the pioneering pharmaceutical industry .
Since the new crown pandemic in early 2020, the pioneering pharmaceutical industry has rapidly started research on the use of procrulamide for the treatment of new crowns
.
At present, procrulamide is undergoing three global multi-center phase III clinical trials of new crown treatment in the United States, South America (including Brazil), the European Union, Asia and other countries and regions, and was granted the first emergency use authorization by Paraguay in July 2021 (EUA)
.

Prokalamide is a new generation of androgen receptor antagonist independently developed by Pioneer Pharmaceutical

Drug name: BAT2206

Drug name:

Authorized party: Biotech

Authorized party:

Introducer: Hikma

Introducing party:

On August 27th, Biotech announced that it has signed a licensing and commercialization agreement with Hikma Pharmaceuticals USA Inc.
(Hikma) to license the exclusive commercial rights of BAT2206 (usnumab) injection in the US market to Hikma for a fee
.

According to the agreement, Biotech will receive a down payment of 20 million U.
S.
dollars, a cumulative milestone payment of no more than 130 million U.
S.
dollars and commercial royalties, and a double-digit percentage of net sales as the supply price
.

It is reported that BAT2206 is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23
.
Among them, IL-12 and IL-2 are naturally produced cytokines that can participate in inflammation and immune response processes.
They can specifically bind to p40 subunits with high affinity and block their binding to cell surface receptors, thereby destroying IL -12 and IL-23 mediated signal transduction and cytokine effects
.
Currently, the drug is undergoing a global phase III clinical study for the treatment of plaque psoriasis
.

BAT2206 is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23
.