Which companies and innovative drugs will be successfully licensed to the outside world in China by 2020?

2020 is over.
past year, licensing cooperation in the field of innovative pharmaceuticals has been active in the global field.
, especially in China, the introduction of new drugs (license-in) has become very common, and a number of projects developed by local Chinese companies have been successfully licensed to the outside world.
the latter is more meaningful.
Record-out to help China's innovative drugs to the world in the early days of China's innovative drugs, there have been individual "license-out" cases.
2018, as a number of local innovative pharmaceutical companies in China have flourished, more and more independent research and development of innovative drugs have been recognized by other companies around the world, thus reaching authorized cooperation.
According to incomplete statistics, from 2018 to 2019, China has at least a dozen independently developed innovative drugs or products under research and development to achieve external authorization, involving Hengrui Pharmaceuticals, and Huang Medicine, Baiji Shenzhou, Xinda Bio, Fuhong Hanxuan and other companies.
just past 2020, the history of this pattern has been set.
can see that different stages of research and development, different models of products or technologies of external licensing cooperation continues to emerge.
below is a list of some of the more closely watched cases of foreign authorized cooperation between local Chinese companies in 2020 (incomplete statistics) for readers to refer to.
1. Licensing Party: Wanchun Pharmaceutical Subsidiary Wanchun Seed Introducer: Eli Lilly and Company Authorized Technology: "Molecular Glue" Protein Degradation Patented Technology November 2020, Wanchun Pharmaceuticals announced that Its subsidiary, Seed Therapeutics, recently signed a research partnership and licensing agreement with Lilly to jointly develop a new chemical entity (NCE) that plays a therapeutic role through targeted protein degradation (TPD).
a total of $790 million for this cooperation milestone, including a down payment of $10 million.
,000 Springs Seed specializes in the development of unique molecular glues designed to target disease-degrading proteins.
the company's research and development team is led by Dr. Avram Hershko, the discoverer of the ubibin-targeted protein degradation system, the 2004 Nobel Laureate in Chemistry, and Dr. Huang Wei, CEO of Wanchun Pharmaceuticals.
2. Licensor: Fuhong Hanxuan Introducer: Binacea Pharma in the study of products: targeting EGFR and 4-1BB dual-specific antibody HLX352020 November, Fuhong Hanxuan announced a license and co-development agreement with Binacea Pharma, the company developed a dual-specific antibody HLX35 China's overseas interests licensed to the latter.
HLX35 is a dual-specific antibody developed by Fuhong Hanxuan, which aims to develop treatment areas for colorectal cancer and head and neck tumors and other solid tumors at two targets: the periterial cell growth factor subject (EGFR) and 4-1BB (CD137).
HLX35 is still in the preclinical development stage.
3. Licensee: Hengrui Pharmaceutical Importer: DONG-A ST Company Research Products: PD-L1/TGF-β RII Antibody SHR-17012020, Hengrui Pharma announced that Dong-A ST Corporation of Korea has obtained the exclusive clinical development, production and marketing rights of Hengrui Pharmaceutical Anti-Tumor Research Drug SHR-1701 in Korea and is licensed to develop and sell SHR-1701 for all human diseases.
SHR-1701 is a PD-L1/TGF-β RII antibody independently developed by Hengrui Pharmaceuticals, which can target both the PD-L1 path and the TGF-β path, and is expected to awaken and restore the body's anti-tumor response and play an effective role in controlling tumor growth.
that the drug in the study has started a number of clinical studies in China.
4. Licensor: Reintrodesmed Pharmaceutical Importer: Lilly Research Products: Bcl-2 Selective Small Molecule Inhibitor FKN-338 October, Fosun Pharma announced that its subsidiary Regent Pharma has granted Lilly exclusive license to develop, register, produce and commercialize Bcl-2 Selective Small Molecule Inhibitor FCN-338 in all regions of the world except Chinese mainland, Hong Kong and Macau.
FCN-338 is a select inhibitor of B cell lymphoma-2 (Bcl-2), which is intended to be developed to treat malignant tumors in the blood system.
Bcl-2 protein family plays an important role in apoptosis, which is the normal process of cell death.
Lilly plans to launch Phase 1 in the U.S. and will explore the potential of the FCN-338 with products in its pipeline, starting with the FCN-338 and LOXO-305.
5. Licensing Party: Henrui Pharmaceutical Importer: HLB Life Science Products: Malay acid pyridoxine On September 28, 2020, Hengrui Pharmaceuticals and HLB Life Science of Korea reached an agreement to license their anti-cancer drug Malay acid pyridoxine tablets to the latter for a total of $105.7 million, while obtaining a share of the latter's sales.
HLB Life Science will be awarded exclusive clinical development, registration and marketing rights in Korea, as well as production options (excluding API production rights).
, an oral EGFR/HER2/HER4 tyrosine kinase inhibitor developed by Hengrui, was approved for market in August 2018 with Phase 2 clinical studies.
In July 2020, a supplementary application for the revision of the instruction manual was approved, and its joint carpetamine, applicable to the treatment of HER2-positive patients who have received a recurrence of crater monomatosis or metastasis breast cancer, has been converted to full approval.
is currently in the process of covering breast cancer, lung cancer, bile terroid cancer and many other types of clinical research.
6. Licensee: AbbVie in the study of products: CD47 single-resistant lemzoparlimab In September 2020, Skyspace Granted AbbVie the right to develop and commercialize its new CD47 monoclonal antibody lemzoparlimab in countries and regions outside Greater China.
According to the press release, lemzoparlimab is intended to be developed to treat a variety of cancers by retaining a strong binding ability with tumor cells while minimizing binding to normal red blood cells without blood clotting.
7. Licensee: Xinda Bio Importer: Lilly Products: PD-1 inhibitor Xindili Monoanti In August 2020, Thyda Bio and Lilly announced the expansion of strategic cooperation on Xindelli Monoanti.
, an anti-PD-1 monoclonal antibody jointly developed by Xinda Bio and Lilly in China, has been approved in China for the treatment of recurring/refractic classic Hodgkin's lymphoma.
under the agreement, Thyme Bio will grant exclusive license to Lilly-Dilli Mono-Resistance outside of China, and Lilly will be committed to bringing D.E. Mono-Resistance to North America, Europe and beyond.
8. Authorised Party: Sanofi Pasteur: Sanofi Pasteur is working on a new rota virus vaccine At the end of July 2020, Vantai Bio announced that its wholly-owned subsidiary, Sanofi Sea Biology, has awarded Sanofi Bio to develop, produce and commercialize its new rota virus vaccine worldwide.
According to the press release, this is a new rotor virus recombinant protein vaccine that induces high-titular broad-spectrum protection antibodies against multiple serotypes in animals, primarily to prevent diarrhea in children caused by type A rotorvirus.
9. Licensee: Howson Pharmaceuticals Introducer: EQRx Products: Third Generation EGFR-TK Drug Amedini in July 2020, Haussen Pharmaceuticals announced the granting of an exclusive license to EQRx to develop, produce and commercialize its Amedinie outside China.
ametinib is a third-generation EGFR (skin growth factor subject) - TKI (Tyrosine kinase inhibitor) drug developed by Howson Pharmaceuticals.
the drug has been approved in China to treat non-small cell lung cancer, it is the first approved to be approved for the market in China's third generation EGFR-TKI.
10. Licensor: Garcos Pharmaceuticals Introduction: AbbVie Products: SHP2 Inhibitors In June 2020, Garcos Pharmaceuticals and AbbVie announced a global strategic partnership to jointly develop and commercialize the protein tyrosine phosphatase (SHP2) inhibitors that act on key targets for cancer cells and immune cells.
SHP2 is an important signaling regulatory molecule for the RAS/MAPK pathra in cells, and many cancer-causing gene mutations rely on the activity of SHP2 to promote tumor growth.
SHP2 is also an important regulatory factor for controlling cytokine production and immune cell response.
has two oral small molecule drugs, JAB-3068 and JAB-3312, specifically designed to inhibit SHP2 activity.
agreement, AbbVie will be granted exclusive license to the SHP2 program.
will continue with early global clinical studies of JAB-3068 and JAB-3312 until AbbVie begins global development and commercialization, at AbbVie's expense.
11. Licensee: Regency Bio Importer: Lilly Products: New Crown Antibody JS016 In May 2020, Regency Bio and Lilly signed the Research and Development Cooperation and Licensing Agreement, the two sides will cooperate in research and development and commercialization of SARS-CoV-2 and antibody JS016.
JS016 is a recombinant all-human monoclonal neutralizing antibody, specific to the SARS-CoV-2 surface prick protein complex domain, and can effectively block the virus and host cell surface subject ACE2 binding.
agreement, Lilly will obtain exclusive research and development, production and sales licenses for JS016 outside Greater China.
down payments and milestone payments for this transaction amounted to $255 million.
12. Licensee: Hengrui Pharmaceutical Importer: CrystalGenomics Company Products: Anti-PD-1 Single Anti-Carelli Pearl Single Resistance April 2020, Hengrui Pharmaceuticals and Korea Crystal Genomics Company reached an agreement on Karelli Pearl Single Resistance.
Karelli pearl monoantigen is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceuticals and with intellectual property rights, and has been approved in China for four adaptations, covering classic Hodgkin's lymphoma, advanced hepatocellular carcinoma, non-squamous non-small cell lung cancer, esophageal squamous cancer, all of which have been included in China's 2020 National Health Insurance Directory.
agreement, CrystalGenomics will be awarded the exclusive clinical development, registration and marketing rights of Karelli Pearl Monoant in Korea.
13. Licensor: Introduction of Lingke Pharmaceuticals: Unreclosed Products under Study: Unreclosed Preclinical Projects According to Lingke Pharmaceuticals' official website, the company successfully completed an overseas licensing of preclinical candidate compounds in April 2020, with down payments and milestone payments of nearly $200 million and double-digit (percentage) potential sales credits, which are rare in China's preclinical new drug external licensing cases.
, founded in 2018, is dedicated to the development of innovative drugs for treatments such as oncology, immunity and inflammation.
(recommended reading: Lingke Pharmaceutical CEO Dr. Wan Zhaokui: Standing in the wind of China's new drug development, how do start-ups ride the wind and waves?) 14. Licensor: Beida Pharmaceuticals Introducer: EyePoint Pharmaceuticals Products: Vorolanib (CM082) In February 2020, Equinox Sciences, a subsidiary of Bayda Pharmaceuticals, signed a licensing agreement with EyePoint of the United States for Vorolanib (CM082).
Vorolanib is a multi-target subject tyrosine kinase (RTKs) inhibitor for VEGFR and PDGFR targets.
agreement, EyePoint will be granted exclusive authority to develop vorolanib by local injection to treat eye diseases such as wet age-related macular degeneration.
EyePoint will be responsible for the development of the new treatment, EYP-1901, and the global commercialization of the Greater China region for the treatment of wet age-related macular degeneration, diabetic retinal lesions and retinal venous obstruction.
EYP-1901 is a combination of vorolanib and Bioerodable Durasert ™ technology to form a new treatment.
Bioerodable Durasert ™ is an injectable, slow-release glass in vivo dosing system that lasts up to six months.
diversified model to accelerate the benefits of products for patients In addition to the cooperation cases listed above, there are a number of Chinese companies in 2020 to commercialize the products, such as: Keystone Pharmaceuticals has granted Pfizer exclusive responsibility in China for Shugli single-resistance business Biometrics authorized Pharmapark to commercialize its Golimu monobiogenics in countries such as Russia, and awarded Biom to sell its BAT1706 (Beval pearl monobiogenics) in the Brazilian market, among others.
from the above cases of external authorization cooperation can be seen that since 2020, China's innovative pharmaceutical enterprises have shown a diversity of external licensing.
, there are approved products, clinical phase projects, some preclinical projects, and even some innovative cutting-edge patented technologies.
, however, from the therapeutic perspective, most of these licensing programs focus on cancer, an area with significant clinical needs.
industry points out that by empowering cooperation to jointly advance product development and clinical research, synergies can be achieved to accelerate product research, clinical development and commercialization to better meet the needs of patients.
it is worth mentioning that not long ago there was good news from Asaan Medicine.
company's partner, UNITY Biotechnology