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    Home > Active Ingredient News > Drugs Articles > Inventory of blockbuster transactions of pharmaceutical companies in the oncology field in March

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

    • Last Update: 2021-07-14
    • Source: Internet
    • Author: User
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           In the past March, the transactions of pharmaceutical companies were quite active, and multiple transaction forms such as acquisitions and cooperation were parallel.
    Especially in the oncology field, the number of License in (authorized introduction) and license out (authorized introduction) increased.
    Let's sort it out together

    .

           Inventory of transactions in the tumor 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 the highly effective oral antagonist xevinapant (Debio1143) for inhibitors of apoptosis protein (IAP), with a transaction amount of up to 898 million euros
    .
    Xevinapant is a potential "first-in-class" drug.
    It was transferred to Debiopharm, Switzerland, in 2011 by the predecessor of Ascent Pharmaceuticals.
    Treatment of newly treated high-risk locally advanced squamous cell carcinoma of the head and neck

    .

           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 results showed that adding xevinapant in addition to standard care significantly improved the local control rate of the patient's disease after 18 months

    .
    When the follow-up time was 2 years, compared with standard care, the addition of xevinapant reduced the risk of disease progression and death by 63% (HR=0.
    37, 95% CI: 0.
    18, 0.
    76; p=0.
    0069)

    .
    At a follow-up of 3 years, xevinapant reduced the risk of death by 51%

    .

           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.
    9 billion in cash.
    This acquisition aims to enhance the gastric cancer drug candidate bemarituzumab (bemarituzumab) through Fiver Prime's preparation for phase 3 clinical trials.
    Amgen's tumor treatment pipeline

    .

           Bematuzumab is Fiver Prime’s First in Class monoclonal antibody drug.
    By targeting FGF receptor 2b (FGFR2b), it blocks the binding of fibroblast growth factor (FGF) and FGFR2b and inhibits several downstream cancer-promoting signals.
    Pathways, thereby slowing cancer progression

    .

           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.
    5 months, while receiving comfort For the control group of drug and mFOLFOX6, it was 7.
    4 months

    .

           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
    .
    According to the agreement, Pfizer will externally authorize two ADC drug candidates-PYX-201 and PYX-203, and also authorize Pyxis's ADC technology platform, including various load types, linker technology, and site-specific coupling Technology for the development of more ADCs in the future

    .

           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
    .
    PYX-203 targets antigens expressed in certain hematological tumors and uses a DNA damaging agent to reduce the risk of drug resistance and disease recurrence

    .

           Product: Xeloda ® and Tarceva ® in the Chinese mainland market promotion

           Authorized party: Roche

           Transferee: Baiyang Pharmaceutical

           On March 29, Shanghai Roche Pharmaceutical Co.
    , Ltd.
    (hereinafter referred to as "Roche"), a well-known multinational pharmaceutical company, and Qingdao Baiyang Pharmaceutical Co.
    , Ltd.
    (hereinafter referred to as "Baiyang Pharmaceutical") formally signed a cooperation agreement in Shanghai.
    Rhoda® and Tarceva® were promoted in the market in mainland China

    .

           Xeloda® is one of Roche's well-known anti-tumor drugs.
    Its generic name is capecitabine tablets.
    It is a basic drug in the treatment of colorectal cancer, gastric cancer and breast cancer

    .
    It
    has a synergistic effect with a variety of anti-tumor drugs .
    At present, it has obtained marketing approval in more than 100 countries around the world, has accumulated more than 20 years of clinical experience, and has provided effective and flexible treatment plans for more than 1.
    8 million cancer patients

    .
    In China, Xeloda® benefits approximately 160,000 cancer patients every year

    .

           Tarceva®, commonly known as Erlotinib Hydrochloride Tablets, is the first-generation molecular targeted drug produced by Roche for the treatment of lung cancer
    .
    As a classic tyrosine kinase inhibitor (TKI) drug with rich global experience, Tarceva® was approved as a first-line indication for advanced or metastatic non-small cell lung cancer in China in 2017, and was successfully listed in the National Medical Insurance List in 2018.
    It has benefited hundreds of thousands of lung cancer patients and has a good market performance in China

    .

           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
    .
    According to the agreement, Kaixin Yuanda is required to pay Cleave USD 5.
    5 million in advance, as well as up to USD 74 million in development and sales milestone payments and net sales sharing

    .

           CB-5339 is an oral second-generation small molecule VCP/p97 inhibitor.
    Cleave is advancing its phase 1 clinical study for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

    .
    At the same time, the National Cancer Institute (NCI) will also conduct a phase 1 clinical trial to evaluate its application in solid tumors and lymphomas

    .

           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 Pharmaceuticals 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 have 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, as well as Shijian Biology’s outstanding expertise in the early development of antibody drugs and CMC, and the joint development includes 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

    .
    Interim data from the clinical phase 2 study showed that Paxalisib used in MGMT non-methylated new-haired glioblastoma (GBM) patients can significantly improve 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: Siddi 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) exclusive license to develop, manufacture and commercialization
    .
    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 research and development results into a wider market, or facilitate enterprise 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.
    https://       3.
    https://       4.
    https://db.
    dxy.
    cn/v5/home

           5.
    "Yingshi Biological and Shijian Biological Announce Signing of Strategic Cooperation Agreement on Innovative Antibody Drug Development"

           6.
    The official website of each company       

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