Abelvy "seizes" Sanofi "hides" Who will eat meat first in the 60 billion double anti market?
Last Update: 2020-06-19
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Bispecific antibody is about to break out! Based on a large number of data research, this conclusion is drawnIn the second week of June, the double resistance trade entered the highlight time: three transactions in three days, with a maximum amount of 3.9 billion US dollars, involving many well-known MNCs of Roche, Sanofi and Aberdeen, as well as local new and cutting-edge pharmaceutical enterprises such as Cinda and Corning Jerry< br / > behind the hot transactions is the support of R & D progressIn China, kangningjierui announced the latest progress of the first PD-L1 / ctla-double antibody kn046 in ASCO 2020, Cinda biology also announced the preliminary results of the first PD-1 / PD-L1 double antibody clinical ia stage clinical research in the form of wall newspaper at the annual meeting, and kangfangbio announced the latest progress of the first PD-1 / CTLA-4 double antibody ak104 combined chemotherapy in aacr2020Internationally, Johnson & Johnson's Janssen company announced the efficacy of BCMA / CD3 double antibody in phase I clinical treatment of relapsed or refractory multiple myeloma at the annual meeting of eha2020Overall, these clinical progression preferencesIn addition, amg199, a double anti amg199 targeting MUC17 / CD3, was also granted orphan drug qualification by FDA last week< br / > on June 11, Alberta and genmab announced that they had reached extensive R & D cooperation to jointly develop three next-generation bispecific antibody products of genmab, including its main candidate, epicortitamabAt the same time, the two companies will also cooperate to discover and develop other differential antibody anti-cancer therapiesAlberto will pay $750 million in upfront payments to genmab, with potential milestone payments of up to $3.15 billionIt is reported that epcoritamab is a double antibody targeting at CD3 / CD20In the latest clinical trials for patients with follicular lymphoma, it has achieved 86% objective response rate (ORR), and 50% orr in patients with diffuse large B-cell lymphoma, including 3 patients who have failed car-t therapy< br / > US $3.9 billion, Alberto is the next city on the road of double resistance development, and is ranked in the top 10 list of international double resistance developmentNot long ago, in February 2019, abbvie and teneobio and their subsidiary teneonone reached a global development cooperation on BCMA / CD3 dual anti DDoSAt that time, the first stage funds reached 90 million US dollarsAlthough Teneobio can not catch up with the development strength of Genmab in the double anti, its strength can not be underestimatedIn April this year, Geely's kite and teneobio reached a license and cooperation agreement, which agreed that kite was authorized to use teneobio's proprietary human heavy chain antibody platform to develop a new generation of car-t therapy with dual targets for multiple myeloma patients< br / > nowadays, genmab, which cooperates with abwi, is more powerfulIt is the third company next to Amgen and Roche in the current international list of double antibody R & D projectsIt has 10 double antibody products entering the clinical stage, mainly covering blood cancer and non-small cell lung cancer< br / > prior to partnering with Aberdeen, the company authorized Gilead to use its duobody technology platform to develop dual anti HIV drugsThe cooperation between the company and Yang Sen was earlier, and many kinds of dual resistance developed by Yang Sen came from this platformThe most typical is BCMA / CD3 double anti teclistamab, which is used to treat relapsed or refractory multiple myelomaAt present, it is in phase I of clinical practiceAccording to the data from the European annual blood Conference (EHA) in 2020, 78% of patients can get remission under the highest treatment dose< br / > in addition to the nearly $4 billion double antibody transaction, two R & D cooperation transactions on bispecific antibodies took place on June 8A US $2 billion R & D agreement from Cinda biology and Roche to jointly develop a number of bispecific antibodies and cell therapiesRoche is the pharmaceutical company next to Amgen in the research and development of double antibodiesWith this cooperation, Cinda will compete for the top three in the layout of domestic double antibodies< br / > another case comes from corningeri and SanofiBoth parties jointly promote the clinical trial of kn026 combined with docetaxel injectionKn026 is an anti HER2 bispecific antibodyAccording to the agreement, Sanofi will have the right to negotiate and obtain the exclusive license of kn026 within the exclusive period after reaching a specific clinical milestone This move also reflects Sanofi's competition for bispecific antibodies According to Sanofi's latest financial report, there are only three bispecific antibodies in its tumor sector: CD3 / CD123, BCMA / CD3 and muc16 / CD3 < br / > in addition to the giant competition, the restart of the first dual anti drug and the growth of R & D projects also give some signals < br / > at present, there are only three dual antibacterials on the market, one of which is off the market due to multiple factors such as business The other two are blincyto (from Amgen, for the treatment of acute B-lymphocytic leukemia) and hemlibra (from Roche, for the treatment of hemophilia) which were on the market in 2014 and 2017 respectively < br / > it is worth mentioning that the first catumaxomab (targeted at CD3 / EpCAM, used to treat cancerous ascites) which was launched in the world in the middle of the market has restarted GMP production in Europe in 2018 Dr Horst lindhofer, the inventor of the drug, believes that catumaxomab also has excellent performance in advanced gastric cancer in addition to the approved indications, and decides to cooperate with China < br / > in 2017, lingteng pharmaceutical was founded in Hangzhou by Dr Horst lindhofer and Dr Shen Xiao On the company's website, catumaxomab double antibody is currently in the stage of listing and licensing in Europe According to the latest data of CDE, catumaxomab has been approved for clinical use The indication is "not suitable for the treatment of advanced gastric cancer with peritoneal metastasis and systemic treatment" The company plans to apply for listing in China in 2021 and apply for additional indications in 2022 < br / > in addition, nextpharma data shows that by the end of April 2020, about 20% of the antibody drugs in preclinical stage in the world (except mainland China) belong to double antibody, accounting for more than the proportion of ADC test, which is 22% in mainland China; the proportion of double antibody drugs in international stage 1 clinical stage is also close to 20%, and that in mainland China is about 12% Up to clinical stage 2, the proportion in China is higher However, domestic double antibody projects are mainly concentrated in the stage before stage II, and no double antibody drugs have been approved < br / > by the end of February 2020, there were 109 double antibody projects in clinical research in the world (excluding mainland China) and 36 in mainland China Last April, nature released 96 numbers According to Forrest Sullivan's prediction, by 2025, the growth rate of double antibody R & D pipeline will be three times of that of conventional single antibody drugs, and with the new double antibody entering the market, at the same time, more indications have been approved for the listed double antibody, and the market scale will reach 8 billion US dollars (about 56 billion yuan) < br / > it is worth noting that 100% of the research projects in China are tumors, among which PD-1 and HER2 targets are equally divided, accounting for more than 36% of the total, and 23% of the international research projects PD-L1 and CD19 follow closely < br / > according to the agency's forecast of 8 billion USD market, in addition to the two products already on the market, the most likely candidates are clinical phase 3 products, followed by clinical phase 2 products So who are these players? How do they all participate? According to the data of < br / > nextpharma, at present, there are only two double antibody projects in phase III: one is fariimab of Roche, with the fastest progress According to MedSci report, on March 11, 2019, Roche and Genentech launched phase III clinical treatment of fariimab The product targets Ang2 / VEGF-A, which can combine and inactivate angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) simultaneously, and is used to treat diabetic macular edema and wet age-related macular degeneration There is no enterprise layout in China < br / > the other is the dll4-vegf project abl001 of Korean ABL bio company, which is to be developed for chronic myeloid leukemia, and there is no layout in China It is worth noting that in July 2018, ABL bio and Tianjing biology reached an authorized cooperation, that is, ABL bio will obtain the development and commercialization rights and interests of a bispecific antibody (BsAb) project in Tianjing except for Greater China, and pay a total authorized amount of about $100 million for this purpose, according to the news agency The cooperation also involves jointly promoting three other bispecific antibody projects Four months later, ABL bio and Yaoming bio reached an exclusive R & D and clinical production cooperation for up to eight new antibody drugs, mainly bispecific antibodies < br / > there are 19 projects in clinical phase II, including zw25, which is developed by zymeworks company and targeted at HER2, and is used to treat cancer, autoimmune and inflammatory diseases In November 2018, Baiji Shenzhou announced to obtain the exclusive development and commercialization rights and interests of zw25 in Asia (excluding Japan), Australia and New Zealand, It also includes the cooperation of many other bispecific antibodies This is the only double antibody in clinical phase 2 in Baiji, but there are more than 10 double antibodies in clinical phase 1 or even earlier in Baiji < br / > and regn 1979, which is targeted at CD3 / CD20, developed by regenerator, are also in clinical phase 2 On April 8 this year, zaiding pharmaceutical announced that it had obtained the right to develop and commercialize regn 1979 in mainland China, Hong Kong, Taiwan and Macao According to the agreement, zaiding pharmaceutical needs to pay a maximum of USD 190 million to zaiding < br / > generally speaking, the international first echelon is Anjin (16), Roche (13), genmab (10), the second echelon is macrogenetics (8), xencor (8), J & J (7), AZ (5), regenerating yuan (5), etc < br / > in China, the introduction school represented by Baiji Shenzhou and zaiding Pharmaceutical Co., Ltd has occupied some seats in the development of domestic double resistance, but there are also independent research and development schools running ahead For example, kangfang biology, which just listed in Hong Kong stock market, and Corning Jerry, which listed in Hong Kong stock market last year, are potential players in the development of domestic double resistance Their R & D progress is definitely in the first tier, and they are ahead of the global progress in corresponding targets < br / > there are two kinds of double antibodies in clinical phase 2, kn046 and kn026, kn046 targeting PD-L1 / CTLA-4 Currently, phase II clinical trials are being carried out in China and the United States At asco2020, corningeri released the clinical data of kn046 in patients with advanced solid tumor who failed to receive the previous immunosuppressant treatment Of the 25 patients who met the evaluation criteria, Orr was 12.0%, disease control rate was 52.0%, median PFS was 2.69 months, and median OS data has not been achieved The PFS rate at 3 and 6 months was 41.0% and 21.9%, and the OS rate at 6 and 9 months was 88% and 58.7%, respectively < br / > another double antibody targeting HER2 has been studied in phase I clinical dose increasing and expanding in China and the United States, and a number of phase II clinical trials have been carried out simultaneously in China The results of phase I clinical trial showed that kn026 had good tolerance and safety < br / > at present, only one dual antibody of kangfang biology has entered clinical phase 2, and ak104 targets PD-1 / CTLA-4 Kangfang biology will announce the preliminary results of stage Ib / II study of ak104 combined with chemotherapy in the first-line treatment of advanced gastric cancer or adenocarcinoma at the junction of stomach and esophagus at the annual meeting of American Association for cancer research (aacr2020) As of April 2, 2020, there are 19 subjects who can evaluate the efficacy, the objective remission rate is 57.9%, and the disease control rate is 94.7%; some patients have used the drug for more than 42 weeks, and 13 patients are still in continuous treatment Among the 21 subjects, only 2 (9.5%) had grade 3 adverse events related to immunity, and 1 subject stopped medication due to drug-related adverse events < br / > generally speaking, the first echelon in the domestic development progress is corning Jerry, Baiji Shenzhou and kangfang biology; the first echelon in quantity is Baiji Shenzhou, Corning Jerry, Xinda biology, youzhiyou and jiannenglong < br / > original title: double anti Japanese outbreak! AI Bowei's "robbery", Sanofi's "hiding", Baiji Shenzhou likes to "chop hands" Who will eat meat first in the 60 billion market?
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