Drug authorized transactions frequent domestic pharmaceutical research and development strength has increasingly been internationally recognized

Licensing cooperation is a very important part of the new drug research and development industry chain, The License in project can make up for the short board of the enterprise product line, enrich the enterprise product pipeline, and the License out project can smoothly push the enterprise research and development results into a wider market, or help the enterprise integrate the business.
this year's new crown outbreak is raging globally, but licensing cooperation between domestic and foreign drug companies does not appear to have been affected.
incomplete statistics, there will be more than 40 License in projects by November 11, 2020, far more than the number of License out projects (about 20 or more).
China's drug research and development strength, License out project surge since March 2007, micro-core biology outside China's global development rights and interests to the United States HUYA company, China's innovative drugs gradually received international recognition, independent research and development products authorized to overseas developed countries cases are gradually more.
According to incomplete statistics, there have been more than 20 License Out projects in China since 2020 (see table below), mainly involving Hengrui Pharmaceuticals, Xinda Bio, Baida Pharmaceuticals, Fuhong Hanyu, Keystone Pharmaceuticals and other well-known domestic pharmaceutical companies, of which Hengrui Pharmaceuticals accounted for 3 and Xinda Bio accounted for 2.
these License out programs occur primarily in the second half of 2020, with licensed products primarily monosexual antibodies and chemicals that cover tumors, ophthalmological diseases, and autoimmune diseases.
2020 domestic enterprise License-out project situation (as of November 11, 2020) innovative drug one brother strength, three drugs a year out of the sea Karelli pearl monoanti, Malay acid pyridoxine and SHR-1701 clinical development, registration and marketing rights in Korea authorized to South Korea's Crystal Genomics Corporation, HLB Life Science Co., Ltd. and East Asia Inc., with total transactions of $877.5 million, $105.7 million and $139.27 million, respectively.
Of these three products, Karelli pearl monoanti and Malay acid pyridoxine have been approved for listing in China, and Karelli pearl single resistance this year alone has won three new adaptive disorders, submitted two new adaptive diseases to the market application.
SHR-1701 is a dual-specific antibody developed by Hengrui for targeted programmed death ligand 1 (PD-L1)/transformation growth factor-beta-II-type acceptor (TGF-beta RII), which has been approved clinically in China for the treatment of advanced malignant tumors. More than
domestic biosypolytics have been successfully launched in recent years, China's biosynthic drug market is in a period of rapid development, especially after the State Drug Administration has accelerated the process of drug research and development approval, the domestic layout of biosypolytic drugs enterprises have nearly reached 180, nearly 400 drugs, The main targets include CD20, EFGR, VEGF, TNF, RANKL, HER2, etc., involving more than 50 original drugs such as lyxi monoanti, curto bead monoanti, beval bead monoanti, Adamo monoantigen, etc.
it is worth mentioning that in July this year, Fuhong Hanxuan's Quto Zhudan was approved by the European Union and successfully listed overseas.
In an effort to accelerate the overseas listing of domestic biosics, on January 14th Xinhua granted Coherus a commercial interest in IBI305, or Beva Pearl Single Resistance, in the United States and Canada, with a reported down payment of $45 million.
July 17th, Baiotai Bio granted Pharmapark exclusive commercial rights to BAT2506, or Golimu monomatics, in Russia and other CIS countries.
is even more so, in March granting Mabxience exclusive license to Mabxience for the development and commercialization of cancer treatment rights in Argentina, Uruguay and Paraguay, and in October granting exclusive rights to the development, manufacture and commercialization of HLX04 (beva bead monomagnetic) for wet age-related macular degeneration (wAMD) and other eye diseases worldwide.
the domestic three-generation EGFR-TKI Amedini, Avitini as the representative of a number of chemical drugs out of China in March 2020, Haussen Pharmaceuticals Amedini was approved in China before Avitini, becoming the second domestic approval of the second generation of EGFR-TKI, and the first domestic third-generation EGFR-TKI approved.
Howson Pharmaceuticals and Eisen Pharmaceuticals have licensed the overseas interests of the two domestically produced three-generation EGFR-TKI to EQRx and Sorrento in July and May this year, respectively.
addition, there are a number of China's independent research and development of new chemical drugs overseas rights and interests are authorized to foreign enterprises.
, Beda Pharmaceuticals exclusively licensed EyePoint to develop the tyrosine kinase inhibitor Vorolanib (CM082) for the treatment of eye diseases such as w-AMD by local injection.
, Baiji Shenzhou granted Medison exclusive rights to the distribution rights of its BTK inhibitor Zebtini in Israel.
June, Garcos exclusively licensed its SHP2 portfolio to AbbVie.
July, Yanyuan Pharmaceuticals exclusively licensed its clinical development and commercialization interest in the Korean market for its next-generation ROS1/NTRK inhibitor Taletrectinib to NewG Lab Pharma.
November, Fosun Pharma granted Lilly the right to develop, produce and commercialize its B-cell lymphoma factor-2 (Bcl-2) inhibitor FCN-338 in Chinese mainland, all countries and regions outside hong Kong and the Macao Special Administrative Region.
addition to the licensing projects mentioned above, The Worldlife and AbbVie's licensing deal for CD47 single-resistant lemzoparlimab is of great concern to the industry.
nearly $2 billion, a record for an external authorized transfer by a Chinese innovative pharmaceutical company.
and preliminary clinical results show that lemzoparlimab is highly binding to cancer cells and minimizes the effects on red blood cells.
License in mode is on the rise, anti-tumor new drugs are still the main force according to incomplete statistics, there are at least 40 License in projects in 2020 (see table below), mainly around anti-tumor new drugs, ophthalmological diseases, COVID-19, autoimmune diseases, etc. , involving domestic enterprises such as Baiji Shenzhou, Polar Biology, Fosun Medicine, Redding Medicine and so on.
2020 domestic enterprise License-in project situation (as of November 11, 2020) the new crown outbreak led to COVID-19 vaccine research and development, the surge in enterprise cooperation affected by the new crown outbreak, the vaccine used to prevent COVID-19 has become a new direction of enterprise research and development, which further accelerates the cooperation between Chinese pharmaceutical enterprises and overseas enterprises.
, Fosun Pharma entered into a partnership with BioNTech to obtain an exclusive development and commercial license for COVID-19 vaccine products developed by the latter based on its proprietary mRNA technology platform in China for up to $85 million.
It's worth noting that the first mid-term validity of the mRNA new crown vaccine developed by Pfizer in partnership with BioNTech proved more than 90% more effective than expected in phase III clinical trials, a news that sent Fosun Pharma shares soaring.
, the recent clinical trial application for Fosun Pharma's licensed mRNA vaccine BNT162b2 was accepted by CDE and is intended to be used primarily to prevent new coronavirus pneumonia in people aged 18-85.
August, Kantai Bio and AstraZeneatic signed an exclusive authorized partnership framework agreement for the Chinese mainland market to advance the development, production, supply and commercialization of astrayrovirus vector AZD1222 in the Chinese mainland market through technology transfer.
addition, and platinum medicine, Regency Biology, clover biology, Ai Weixin and other companies have reached a different company on the new coronavirus vaccine or antibody cooperation.
anti-tumor drugs are still the main force in License in the field of treatment, licensed products are mainly used for the treatment of tumors, including chemicals, monosexual antibodies, dual-specific antibodies, antibody coupled drugs (ADCs).
drug targets introduced by the company include CDK4/6, BTK, MET, etc., where Jiahe Biologics and Acoustic Pharmaceuticals introduced a CDK4/6 inhibitor lerociclib and trilaciclib (lerociclib developed for use in combination with other targeted therapies in certain types of breast and lung cancer, and trilaciclib for improving the prognostication of chemotherapy in cancer patients).
targets for single-specific antibodies include PD-1, PD-L1, and CTLA-4, where Beda Pharmaceuticals and Baiji Shenzhou introduced a CTLA-4 inhibitor zalifrelimab and BA3071 from Agenus and BioAtla, respectively.
and dual-specific antibodies and three-specific antibodies can bind to multiple targets to mediate a series of immune responses, the current domestic enterprises in addition to independent research and development, but also from foreign enterprises, such as re-ding medicine from the regenerative introduction of targeted CD20 and CD3 dual-specific antibodies REGN1979, Pioneer Pharmaceuticals and Zeitgypyeong Pharmaceuticals introduced dual-specific antibodies GS19 and triple-specific antibodies ZGGS001 targeting PD-L1/TGF-β from Gensun Biopharma Inc.
ADC is a new direction in recent years in the field of antibody drugs, has been approved 10 ADCs worldwide, while only vibutoxi monoantigen and enmetrodone monoantigen have been approved domesticly.
2020, about 4 companies will introduce ADC from foreign companies, namely Saisheng Pharmaceuticals from Tarveda Therapeutics to the micropharmaceutical couple PEN-866 (2020/03), and Qilu Pharmaceuticals from Sesen bio to the EpCAM targeted immunotoxin drug Vicineum (2 020/07), East China Pharmaceuticals introduced the FR alpha-targeted ADC drug Mirvetuximab Soravtansine (2020/10) from ImmunoGen, and Keystone Pharmaceuticals introduced ROR1-targeted ADC drug LCB71 (2020/10).
addition, it is worth mentioning that China's enterprises have also introduced 2 lysovirus products from foreign enterprises.
January, Pumis Biology introduced TILT-123 from TILT Biotherapeutics in Finland, a human 5/3 chime adenovirus that selectively replicates and dissolves only in most human tumor cells.
In May 2020, Tiansli Pharmaceuticals introduced C-REV, a lysovirus product from Takara Bio, a type 1 herpes simplex virus (HSV-1) detox strain that selectively replicates and breaks down tumor cells without damaging normal cells and is currently being developed to treat pancreatic cancer and melanoma.
Ophthalmology field is a blue sea, domestic enterprises have laid out in recent years, the aging of the population, widespread use of electronic products, improper use of eyes and other factors make the incidence of various types of eye diseases in China on the rise, eye infections, conjunctivitis, macular degeneration, dry eye disease, myopia and other eye diseases increased significantly.
data show that the size of China's ophthalmology market grew from 46.7 billion yuan to 86.6 billion yuan in 2013-2017, with a compound annual growth rate of 16.7%.
in addition to the domestic ophthalmology field leading enterprises such as Eyre ophthalmology, Opcon Vision and Aibo Medical, other domestic enterprises have also begun to this field.
January, Ocon vision received a 9% DEXYCU® of EyePoint Pharmaceuticals for the development and commercialization of inflammation after eye surgery in Chinese mainland, Hong Kong, Macau and Taiwan.
August, Polar Creatures, which is dedicated to new ophthalmology therapies, introduced MicroPine, an innovative treatment for advanced myopia, from Eyenovia, USA, and MicroLine, an innovative treatment for old vision, also known as "old eyes".
In October, Mega ophthalmology entered into an exclusive franchise agreement with Nevakar, Inc. to obtain the rights to develop, manufacture and commercial production of the latter's myopia-reducing drug NVK-002 in China, Hong Kong, Macau, Taiwan, South Korea and other countries in Southeast Asia.
In addition to the above-mentioned project licensing transactions between domestic and foreign enterprises, a number of licensing transactions have also occurred between domestic enterprises in 2020, such as Hansen Pharmaceuticals obtained the exclusive development and commercialization interest of TRN-000632 protein structure inhibitor TRN-000632 in Greater China, and Lizhu Pharmaceuticals obtained the same source. Kang Pharmaceuticals A ROS1/NTRK/ALK multi-kinase small molecule inhibitor in Greater China's exclusive development and commercial rights, Regent Bio obtained Zhido Bio license to develop and commercialize IL-2 drugs (LTC002) worldwide and use the relevant patented technology exclusive license, Shanghai Pharmaceuticals obtained also Noo micro-pharmaceutical solution