Cooperation | Inventory of blockbuster transactions of pharmaceutical companies in the oncology field in March

In the past March, the transactions of pharmaceutical companies were quite active, and multiple transaction forms such as acquisitions and cooperation were parallel.

Inventory of transactions in the oncology field of large pharmaceutical companies

Incompletely organized based on public information

Product: Xevinapant

Authorized party: Debiopharm

Transferee: Merck

On March 1, Merck announced that it has reached a global license agreement with Debiopharm to develop a highly effective oral antagonist of apoptosis protein (IAP) xevinapant (Debio1143), with a transaction amount of up to 898 million euros.

At the end of February 2020, based on the results of xevinapant's phase 2 clinical trial, it obtained the FDA-approved breakthrough therapy designation for squamous cell carcinoma of the head and neck.

The positive long-term efficacy of Xevinapant in phase 2 clinical studies indicates that IAP antagonists may become a revolutionary method for the treatment of head and neck cancer.

Product: Bemarituzumab

Authorized party: Five Prime Therapeutics

Transferee: Amgen

On March 3, the international pharmaceutical giant Amgen announced the acquisition of Five Prime Therapeutics for US$1.

Bematuzumab is Fiver Prime’s First in Class monoclonal antibody drug.

In January of this year, Fiver Prime announced at the American Society of Clinical Oncology Gastrointestinal Cancer Annual Meeting that the median progression-free survival of patients randomized to receive bematuzumab combined with chemotherapy (mFOLFOX6) was 9.

Previously completed Phase 2 clinical trials of bematuzumab in the treatment of FGFR2b positive and HER2 non-positive advanced gastric cancer or gastroesophageal junction cancer also showed statistically significant and clinically significant improvements.

Products: PYX-201, PYX-203 and ADC technology platform

Authorized party: Pfizer

Transferee: Pyxis Oncology

On March 18, Pfizer and American biotechnology company Pyxis Oncology (hereinafter referred to as "Pyxis") jointly announced that they have reached a global licensing agreement for two ADC (PYX-201, PYX-203) candidate products.

Although no specific financial figures were disclosed, as part of the transaction, Pfizer could obtain advance payments and Pyxis equity, as well as milestone payments based on development and sales, as well as tiered royalties on potential sales.

PYX-201, a non-internalized ADC, targets tumor-restricted antigens overexpressed in several solid tumor types, selectively killing tumor cells, and at the same time enhancing anti-tumor immune response.

Product: Market promotion of Xeloda® and Tarceva® in mainland China

Authorized party: Roche

Transferee: Baiyang Pharmaceutical

On March 29, Shanghai Roche Pharmaceutical Co.

Xeloda® is one of Roche's well-known anti-tumor drugs.

Tarceva®, commonly known as Erlotinib Hydrochloride Tablets, is the first-generation molecular targeted drug produced by Roche for the treatment of lung cancer.

Inventory of transactions in the oncology field of domestic pharmaceutical companies

Incompletely organized based on public information

Product: CB-5339

Authorized party: Cleave

Transferee: Kaixin Yuanda

On March 8, Kaixin Yuanda signed an exclusive license agreement with Cleave, a clinical-stage biopharmaceutical company, and Kaixin Yuanda obtained the license rights of Cleave's world's first innovative drug VCP/P97 inhibitor CB-5339 in Greater China.

CB-5339 is an oral second-generation small molecule VCP/p97 inhibitor.

Product: BPI-7711

Authorized party: Beierda Pharmaceutical

Transferee: CSPC

On March 9, CSPC announced that its wholly-owned subsidiary CSPC (Shanghai) Co.
, Ltd.
has entered into a product licensing and commercialization agreement with Shanghai Beierda Pharmaceutical to obtain the third-generation EGFR-TKI (BPI) through equity subscription.
-7711 capsules) exclusive product authorization and commercialization rights.

At the same time, CSPC agreed to subscribe for equity from Beierda Pharmaceutical.
The initial subscription amount is RMB 200 million, which can only be implemented after certain prerequisites are fulfilled.

BPI-7711 is an irreversible and highly selective third-generation small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which has significant inhibitory activity against EGFR sensitive mutations and EGFR T790M resistant mutations.

Product: Antibody drug

Authorized party: Yingshi Bio

Transferee: Shijian Biological

On March 11, Yingshi Biotechnology (Nanjing) Co.
, Ltd.
(hereinafter referred to as "Yingshi Bio") and Shanghai Shijian Biotechnology Co.
, Ltd.
(hereinafter referred to as "Shijian Bio") announced that the two parties had signed a strategic cooperation in the development of innovative antibody drugs.
Agreement to jointly develop a series of innovative new anti-tumor antibody drugs, including anti-human CD47 humanized monoclonal antibodies.

According to the agreement, the two parties will give full play to the strong advantages of Yingshi Biology in translational medicine and clinical development, and Shijian Biology’s outstanding expertise in the field of early antibody drug development and CMC, and jointly develop the second-generation CD47 humanized single-domain antibody.
Of new antibody drugs.
At the same time, the two parties will also focus on the joint development of ADC drugs for new targets based on clinical needs and advances in disease biology.

Product: RET Kinase Inhibitor Project

Authorized party: Kelun Pharmaceutical

Transferee: Ellipses Pharma LTD

On March 25, Kelun Pharmaceuticals announced that its subsidiary Kelun Botai has reached a regional licensing cooperation agreement with Ellipses Pharma LTD in the United Kingdom.
Kelun Botai exclusively licensed the European and American rights of the innovative small molecule tumor-targeted RET kinase inhibitor project (A400 project) to Ellipses for a fee, and retained the rights in Greater China, South Korea, Singapore, Malaysia and other parts of the Asia-Pacific region.
The two parties will carry out development, commercialization and other activities in their respective regions, and use the data in their respective regions to support the global research and development of the project.

The A400 project is a small molecule selective targeting RET kinase inhibitor with independent intellectual property rights developed by Kelun Botai.
The project has formally submitted an IND application to NMPA in March 2021, and has laid out a number of international patents.

Pre-clinical studies have shown that A400 has good in vivo and in vitro kinase inhibitory activity and selectivity; it has advantages in animal blood/brain exposure; it is effective for a variety of clinical drug resistance mutations that have been reported in the clinic.
A400 has the potential to overcome clinical drug-resistant mutations and improve the clinical efficacy of brain metastases.

Product: Paxalisib

Authorized party: Kazia Therapeutics

Transferee: Simcere Pharmaceutical

On March 29, a subsidiary of Simcere Pharmaceutical Group Co.
, Ltd.
(Sincere Pharmaceuticals) and Kazia Therapeutics (Kazia), an Australian oncology drug development company, signed an exclusive license agreement.
Simcere Pharmaceuticals obtained Paxalisib in the Greater China region (Mainland China, Hong Kong, Macau and Taiwan) development and commercialization rights for all indications.
According to the agreement, Simcere is required to pay Kazia a certain down payment, milestone payment and Paxalisib sales share in China.

Paxalisib is a PI3K/mTOR pathway inhibitor with high blood-brain barrier penetration.
It is currently undergoing global phase 2/3 GBM AGILE glioblastoma platform clinical trials.
The interim data of the clinical phase 2 study showed that Paxalisib used in MGMT non-methylated new-haired glioblastoma (GBM) patients can significantly improve the median survival (mOS) and median progression-free survival (mPFS) .

Product: RX208

Authorized party: Runxin Biological

Transferee: Fuhong Henlius

On March 29th, Henlius Group and Runxin Biotechnology Co.
, Ltd.
(Runxin Biotechnology) reached an exclusive license cooperation, and Henlius obtained the BRAF V600E inhibitor RX208 in China (including Hong Kong, Macau and Taiwan).
Exclusive rights for research, development, production and commercialization.
Fuhong Henlius is required to pay 164 million US dollars to Runxin Biotech, as well as the sales commission after the product goes on the market.

It is reported that RX208 is a selective small molecule inhibitor for BRAF V600E mutation.
It is clinically intended to treat locally advanced or metastatic solid tumors that are positive for BRAF V600E mutation and are not suitable for surgery.
Preclinical research results show that RX208 has significant tumor suppressor activity and good safety.
It is currently in clinical phase 1, and early clinical studies have also shown initial efficacy with low side effects.
RX208 is expected to become a Best-in-Class BRAF V600E small molecule inhibitor.

Product: IMC-002

Authorized party: ImmuneOncia Therapeutics

Transferee: Sidi Medicine

On March 31st, Sidi Medicine and ImmuneOncia Therapeutics (ImmuneOncia) reached a cooperation agreement, Sidi Medicine obtained a new generation of anti-CD47 monoclonal antibody IMC-002 tumor indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan) The exclusive authorization for the development, production and commercialization of According to the agreement, Sidi Medicine is required to pay ImmuneOncia a down payment of US$8 million, a development and commercial milestone payment of up to US$462.
5 million, and a certain percentage of IMC-002’s annual net sales in Greater China.

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.
Existing preclinical data show that IMC-002 has a strong affinity with human CD47, which can maximize the efficacy without binding to red blood cells or causing anemia and other common side effects of other CD47 inhibitors under investigation.
At present, the drug is in the global phase 1 clinical development stage.

Licensing cooperation is a very important link in the new drug research and development industry chain.
The License in project can make up for the shortcomings of the company’s product line and enrich the company’s product pipeline, while the License out project can smoothly push the company’s R&D results into a wider market or facilitate corporate integration.
Business, the above is part of the transactions in the oncology field of international and domestic pharmaceutical companies in March, and the editor will continue to pay attention to it.

Reference source:

1.
FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143 for Front-line Treatment of Head & Neck Cancer.
Retrieved February 27, 2020.

2.