At present, the development of innovative drugs in China is progressing rapidly, with only 7 new molecular drugs approved in 2016, 42, 60 and 57 in 2017, 2018 and 2019, and a new breakthrough in 2020.
The success rate of domestic new drug development seems to be higher than the overseas average, on the one hand, most of the domestic clinical research and development of new drugs is still in a relatively early stage, on the other hand, Lice in's research and development model has long been a trend, skip the long process of early internal development, quickly integrate external coordination or complementary resources, for the company as soon as possible to bring in line with the overall strategic planning of the product line, but also achieved a number of domestic innovative pharmaceutical companies based on Lice in, such as Reding Pharmaceuticals, Yunding New Yao, cornerstone pharmaceutical industry.
From the distribution of disease areas, the 2020 License in project and the situation in the last five years is consistent, the field of oncology is still hot, endocrinology, neuroscience and other fields than in recent years trading trends have not changed, affected by the new crown outbreak, originally not a hot area of infection in recent years, the surge in trading projects, in addition, ophthalmology is also an increasingly active area of trading.
2020 Chinese pharmaceutical company License in project adaptation distribution in 2020 Lice in more than one project of Chinese pharmaceutical companies, just two days ago on December 28, Reding Pharmaceuticals and Cullinan Oncology reached an exclusive authorized cooperation to promote clN-081 development, production and commercialization in greater China.
under the terms of the agreement, Cullinan Pearl, a subsidiary of Cullinan Oncology, will receive an advance payment of $20 million and will be eligible for development, registration and sales-based milestone payments of up to $211 million.
addition, Reding Pharmaceuticals will pay Cullinan royalties based on clN-081's annual net sales in Greater China, including Chinese mainland, Hong Kong, Macau and Taiwan.
will be awarded exclusive rights to the development, manufacture and commercialization of CLN-081 in Greater China.
Tumor Hot Target and New Target Exploration This year Baiji Shenzhou is the most selected company in China, research and development pipeline has been mainly tumor, including the introduction of CTLA-4 this year bioAtla tumor microen environmental conditions active antibodies Technology (CAB) to address the toxicity of CTLA-4 antibodies, which makes the current layout of the Baiji Shenzhou immune checkpoints include PD-1, PD-L1, TIM-3, TIGIT, OX40, and CTLA-4.
addition to the rare tumor field, the introduction of anti-GD2 antibody stoxi monoantigen in January this year submitted a listing application.
Sound Pharmaceuticals is not a traditional cancer player, but this year continues to strengthen tumor pipelines through License in, with products such as immune checkpoint monoantigens, small molecule drugs and CAR-T all involved, and other products have been developed and commercialized in addition to the exclusive promotion rights of KN035 (Envafolimab) for all tumor adaptations in China.
started research and development of new drugs with a diagnostic start-up, the goal has also been oncology immunotherapy, spending a total of $400 million this year to continue to add code-up oncology immunotherapy, introducing GPS for WT1 cancer immunotherapy, and by suppressing GA The AVB-500, which is conducted by the S6-AXL signaling path and regulates the tumor microencancer environment, both products show the potential for single-drug use or in association with the introduction of the PD-L1 inhibitor KN035.
addition, RMX1001 and RMX1002, two new analgesic drugs potentially used in tumor patients, have been introduced from Haihe to improve the layout of full-cycle therapy for tumor immunotherapy.
Ophthalmology drugs continue to heat up In addition to tumors, disease research and development is heating up the field of ophthalmology, the eye is the window to the mind, but the field of ophthalmology drugs has not been thought to be a billion dollars market, with Abersip successful as a first-line therapy such as wAMD and DME, the drug has become the world's top ten best-selling drugs for ophthalmology treatment.
anti-VEGF market is the hottest research and development direction in the ophthalmology market, the current domestic ophthalmology anti-VEGF drugs Ocon Vision, Qilu Pharmaceuticals, Zhuhai Billion Sheng and so on have layout.
There is also Zhuhai Yisheng with a total of no more than 43 million U.S. dollars to obtain the development and commercialization of ophthalmic adaptations such as the treatment of wet age-related age-related macular degeneration (wAMD) in Fuhong Hanyu Beval beads, and Chongqing Laimei has also introduced Y-400 from Wuhan Youzhiyou.
another area of warming ophthalmology is myopia, where about 1.4 billion people worldwide suffer from myopia, and the drug currently considered effective for controlling myopia is low-dose atropy eye drops.
On October 19 this year, Zhaoke Ophthalmology, a subsidiary of Lee's Big Pharmaceuticals, announced that it had reached an agreement with Nevakar to import products that would cost up to $102 million to obtain exclusive commercial rights to low-concentration ato products in Greater China, South Korea and some Southeast Asian countries.
also introduced MicroPine, an Optejet micro-drug delivery platform, from Eyenovi.
domestic ophthalmology companies are accelerating the pace of self-study and License in model, to foreign enterprises (such as Sengtian, Ayr Jian, Dr. Lun, etc.) as the leading domestic ophthalmology treatment market pattern launched a shock.
investment in dual anti-technology, however, this year's most eye-catching deals came from a partnership of two dual-anti-technology platforms, which were almost the largest.
June 9, 2020, Xinha Bio and Roche reached a $2 billion partnership to develop generic CAR-T therapies and TCB dual resistance, including the glofitamab, which gained notch in EHA in 2020.
Glofitamab is a 2:1 CD20/CD3 dual resistance, a 2:1 structure designed to make it more binding to CD20 on the surface of B cells, inducing rapid T-cell activity, cytokine release, and causing target cell cleavage.
July 2020, Junshi Bio and Revitope reached a cooperation agreement, Junshi Bio introduced the latter developed a dual antigen-oriented T-cell chime-in-active platform (TEAC) patented technology platform, the development of 5 CD3 dual resistance.
target cd3 to activate the anti-tumor activity of T cells is currently a popular target choice for dual anti-development, improving accuracy and reducing toxicity is the common goal of various technologies.
Roche's 2:1 type has two CD20 binding regions, making it more binding to the tumor cell surface antigen, while Revitope chose to change the CD3 part mainly, first split the CD3 part into two CD3 semi-antibodies, and then into the tumor microenvironment will be assembled to form a complete CD3 antibody to reduce its off-target toxicity.
based on the success of CD20/CD3 dual resistance in blood tumors represented by Glofitamab, more dual anti-technology platforms will be a major focus for domestic and foreign pharmaceutical giants in the development of new cancer drugs.
Junshi and Xinda's introduction of dual-anti-technology platforms to distinguish ADC momentum is booming in 2020 whether foreign or domestic, ADC self-research and Lice in momentum is booming, Gilead waved, $21 billion acquisition of Immunomedics to acquire its newly launched ACD product Trodelvy, followed by Mercedon and ADC research and development leader Seattle Genetics announced a total value of $4.2 billion.
October 2020, Keystone Pharmaceuticals introduced LB-targeted ROR1 ADC drug LDC71 with an advance of $10 million and a milestone amount of $353.5 million.
has three ADC deals targeting ROR1 this year, and just a month after Merck bought Velosbio for $2.8 billion, its rival NBE-Therapeutics was bought by Grigg Ingham for $1.5 billion.
the fastest clinical progress was Velosbio's VLS-101, and results published in ASH showed a total remission rate of 55% in 20 patients with multi-line therapy for lymphoma.
VLS-101's efficacy in patients with sleeve lymphoma (red) and DLBCL (blue) In the same month, East China Pharmaceuticals introduced lmmunoGen's Targeted FR with a $40 million advance and a milestone amount of $265 million. Mirvetuximab Soravransine, the ADC drug for alpha (folic acid α), suffered a setback last year when its overseas trial results were tested, with mirvetuximab soravtansine being used in up to three single drugs in a study called FORWARD I In patients with platinum-resistant ovarian cancer who had previously treated them, there was no significant difference in PFS compared to chemotherapy drugs (PEG liposome polyflexes, topotisol or yew alcohol), HR=0.98, p=0.9 87, the subgroup analysis found that the FR alpha high expression population saw the benefit, HR s 0.69, p s 0.049, so will try to be used with beva bead monoantial, chemotherapy drug combination for the whole population or single for FR alpha high expression population.
License in may increase the risk due to overseas clinical failure, such as the introduction of Avapritinib in GIST clinical failure, the introduction of the nuclear casing inhibitor Vebicorvir clinical failure in hepatitis B II, but this will also be an effective warning to avoid risks in the domestic clinical development, after all, the new drug development road, risk and benefit have always coexisted.