The licensing and cooperative development of innovative drug projects between China and other countries in the world are becoming increasingly active. The License in can not only quickly integrate external collaborative or complementary resources, and bring pharmaceutical companies a product line that conforms to the overall strategic plan as soon as possible, but also quickly achieve a number of innovative pharmaceutical companies focusing on License in, such as ZaiLab Pharmaceutical, Everestmedicines and Cstone Pharmaceutical.
License-in is not only a project, but also promotes the growth of new pharmaceutical companies.
With the distribution of disease areas, according to Pharmadigger data, the License in the project in 2020 is consistent with the situation in the past five years, and the oncology field is still hot, while the endocrinology, neuroscience and other fields have not changed compared with the trading trend in recent years. Due to the impact of the COVID-19 epidemic, the trading projects in infection fields that were not hot have surged in recent years.
| Introducing party | Authorizing party | Drug | Disease | Transaction volume |
|---|---|---|---|---|
| Innovent Biologics | Roche | Develop universal CAT-T therapy and TCB double-resistant, including Glofitamab | Tumor | 2 billion dollars |
| Shanghai Junshi Biosciences | Revitope Oncology | T cell chimeric activation cancer therapy with dual antigen is target | Tumor | 810 million dollars |
| BeiGene, | Assembly Biosciences | Vebicorvir,ABI-H2158,ABI-H3733 | Hepatitis B | 540 million dollars |
| LianBio | BridgeBio Pharma | Infigratinib, BBP-398 | Tumor | 532 million dollars |
| Huadong Medicine | ImmunoGen Inc | Mirvetuximab Soravtansine | Tumor | 305 million dollars |
| Grandpharma | Telix Pharmaceuticals | Radigenic nuclei coupling drug for tumor treatment and diagnosis，TLX591,TLX250,TLX101,TLX591-CDX,TLX250-CDX,TLX599-CDX | Tumor | 275 million dollars |
| Zai Lab | Cullinan Oncology | CLN-081 (EGFR inhibitor) | Tumor | 230 million dollars |
| Inmagene Biopharmaceuticals | Affibody | ABY-035 (IL-17 antibody) | Self-immune | 225 million dollars |
| 3D Medicines | Aravive | AVB-500 (Gas6's high affinity FC fusion protein) | Tumor | 219 million dollars |
| 3D Medicines | SELLAS | Galinpepimut-S, GPS+ | Tumor | 210 million dollars |
| BioNova Pharmaceuticals | Carna Biosciences | AS-1763 | Tumor | 205 million dollars |
| Fosun Pharma | BioNTech SE | BNT162 MRNA vaccine | coronavirus | 250 million Euro |
| Apollomics | GlycoMimetics | Uproleselan, GMI-1687 | Tumor | 199 million dollars |
| Zai Lab | Regeneron Pharmaceuticals | REGN1979 | Tumor | 190 million dollars |
| Fosun Pharma | Polyphor Ltd | Balixafortide | Tumor | 182 million dollars |
| Fosun Pharma | Polyphor Ltd | CXCR4 antagonist | Tumor | #rowspan# |
| Zai Lab | Turning Point | Repotrectinib | Tumor | 176 million dollars |
| Simcere Pharmaceutical | G1-Therapeutics | Trilaciclib | Tumor | 170 million dollars |
| BeiGene | Bio-Thera Solutions | BAT1706 | Tumor | 165 million dollars |
| BeiGene | EUSA Pharma | SYLVANT®，QARZIBA® | Tumor | 160 million dollars |
The most eye-catching transaction in 2020 comes from the cooperation of two dual-anti- technology platforms, and almost becomes the transaction with the largest amount. On June 9, 2020, Cinda Bio and Roche reached a cooperation of 2 billion U.S. Dollars to develop universal CAR-T therapies and TCB double antibody, including glofitamab, which became famous in EHA in 2020. Glofitamab is a 2:1 type CD20/CD3 double antibody, and this 2:1 type structure design makes its binding to CD20 on the surface of b cells higher.Induced rapid T cell activation, cytokine release and target cell lysis. In July, 2020, Junshi Bio and Revitope reached a cooperation agreement, and Junshi Bio introduced the patented technology platform of Double Antigen Oriented T Cell Chimeric Activation Platform (TEAC) developed by the latter, and developed five CD3 double antibodies.
Chinese pharmaceutical companies speed up going to sea.
Chidamide, independently developed by Shenzhen Microchip, is a pioneer in the external authorization of new drugs in China. In 2006, it transferred global patents except China to Huya for US$ 28 million. Chipscreen Biosciences is the first company in China to authorize innovative drugs. Because chidamide is still in the early clinical stage, the price is relatively low. To this day,Chinese pharmaceutical companies are more diversified in licensing overseas rights and interests, including commercialization promotion, development and commercialization of technology platforms and clinical products.
China’s integration with the world is increasing, and the mode of going out to sea is becoming more and more diversified. If commercialization authorization is a good choice for Chinese pharmaceutical companies to go out to sea to explore the international market, then the development of technology platform and early clinical products and the external licensing of commercialization rights may also be a good opportunity for overseas pharmaceutical companies to “treasure hunt” in the East, and the transaction scale is also increasing.
In 2020, the record of the highest amount of innovative drugs authorized in China was set by Albertville, which obtained the license for the development and commercialization of CD47 monoclonal antibody lemzoparlimab(TJC4) from Tianjing Bio for a total amount of nearly US$ 3 billion. This is a key step for AbbVie to choose to quickly enter the development of CD47. Compared with Gilead’s purchase of Forty Seven for 4.9 billion US dollars,Albertville’s transaction is very affordable, and TJC4 is considered to have unique advantages, because its characteristics are realized through additional red blood cell anti-screening, and it is screened that it can bind with CD47 with high affinity, but not with red blood cells, or at least with red blood cells. Albertville believes that lemzoparlimab and Venclexta in its own pipeline are potential therapeutic drug combinations.
In addition to KRAS, SHP2, which is also involved in the regulation of RAS pathway, is the most popular target in the field of small molecules. As SHP2 is not only the key node of KRAS-MAPK signal pathway which is widely involved in tumor growth regulation, but also has the functions of inhibiting CD28 and reducing CD8+T cells killing tumor, qinhao medicine and Beijing jiakesidu License out SHP2 inhibitor in 2020. According to the development plan published by Garcos,At present, the development of SHP2 inhibitor is not only as monotherapy, but also can be combined with PD-1 antibody, MEK inhibitor and KRASG12C inhibitor for various solid tumors.
| Authorizing party | Introducing party | Authorized Products | Indications | Transaction volume |
|---|---|---|---|---|
| I-Mab | AbbVie Inc | Lemzoparlimab | Tumor | 3 billion dollars |
| CStone | EQRX | CS1001, CS1003 | Tumor | 1.3 billion dollars |
| Innocent Biologics | Eli Lilly&CO | Sintilimab | Tumor | 1 billion dollars |
| Jiakesi New Drug Development | AbbVie Inc | JAB-3068, JAB-3312 | Tumor | 855 million dollars |
| Henlius Biotech | Binacea Pharma | HLX-35 | Tumor | 760 million dollars |
| Oneness Biotech, Microbio | LEO Pharma A/S | FB825 | Specialty dermatitis and asthma | 570 million dollars |
| Huamedicine | Bayer | Dorzagliatin | Diabetes | 4.48 billion RMB |
| Falcon Pharmaceuticals | Eli Lilly&CO | FCN-338 | Tumor | 440 million dollars |
| Ankang Biological Technology | LG Chem Ltd | TT-01025 | NASH | 350 million dollars |
| I-Mab | Kalbe Farma | TJD | Tumor | 340 million dollars |
| Genhousebio | Huyabio | HBI-2376 | Tumor | 280 million dollars |
| Junshi Biosciences | Eli Lilly&CO | Novel coronary virus pneumonia and antibodies | Virus | 245 million dollars |
| Origincell Biotech | Double-resistant | Tumor | 142 million dollars | |
| Hengrui Medicine | DONG-A ST | SHR-1701 | Tumor | 139.27 million dollars |
| Hengrui Medicine | HLB Life Science | Pyrotinib | Tumor | 105.7 million dollars |
International pharmaceutical companies still attach great importance to China’s sales market, and combine their commercial advantages in specific diseases in China to get the opportunity of new drug license out of innovative pharmaceutical companies in China. On August 17, 2020, Bayer made a down payment of RMB 300 million and a milestone payment of up to RMB 4.18 billion, and obtained the exclusive commercialization right of Dozza Gliadine China of Hualing Medicine.Responsible for its marketing, promotion and medical education activities in China. Bayer has gained the advantages of Chinese diabetes drug treatment market through products such as Baitangping and ELIYA in China, and plans to launch Wave Form dynamic blood glucose monitoring system in China, providing Chinese diabetes patients with an overall plan from prevention and diagnosis to treatment and complication management.Similarly, Pfizer obtained the academic promotion right of its self-developed tetravalent meningococcal conjugate vaccine in Chinese mainland market on July 25, 2020. On September 30th, 2020, it obtained the commercialization authorization of Shuglimab, a tumor product in the later stage of research and development, from Cornerstone Pharmaceutical in Chinese mainland for US$ 280 million.
Except for the License out of commercialization rights, most innovative pharmaceutical companies in China have not started to make profits at present. The development route of new drugs is too long, and it takes nearly 10 years from screening out ideal molecules or potential antibody drugs to successfully putting them on the market, and there are many risks while innovating. How to achieve a relative balance between input and output, innovation and success,It is also a good choice to promote the development of the industry at present to License out the product development rights or technology platform in the early clinical stage.
Innovative companies with core technology thresholds, such as Chengdu Pioneer, Hebao Pharmaceutical, Si Microbiology, Beijing Danxu Bio, etc., have chosen to authorize some products externally, rapidly expand the pipeline of new drug research and development, and at the same time focus more on subdividing technical fields or disease markets.
Behind the increasingly active License-in and License-out, China’s new drug research and development strength has been gradually improved and recognized by overseas markets. It can not rely on foreign enterprises to “import” innovative drugs. Chinese local innovative enterprises are also exploring the cooperation and development in subdivided technical fields to improve the efficiency of new drug development.
