3 days 3 license-in super 2.8 billion traditional pharmaceutical giant innovation transformation into the era of rapid growth

On February 18, East China Pharmaceuticals announced that China East and The United States Havention Bio signed a strategic cooperation agreement to introduce Provental's exclusive development and commercialization interest in Greater China for $189.5 million.
February 17, Howson Pharmaceuticals signed an exclusive license agreement with pharmaceutical company Scynexis.
February 16, Qilu Pharmaceuticals signed a cooperation agreement with Cend Therapeutics, a U.S. biotech company, to obtain exclusive rights to Cend's new cancer drug in Greater China for up to $235 million.
" in the world pharmaceutical industry to accelerate the globalization of today, the eyes in the insulate only staring at local competitors, with the international research giant behind, relying on the first imitation, the era of imitation is over.
" Li Yan, president of Qilu Pharmaceutical Group, told the media.
head of traditional pharmaceutical companies in a series of license-in transactions into the Year of the Ox, but also announced that they with a more active attitude to join the chinese pharmaceutical innovation battle.
2021, BigPharma, Biopharma and Biotech will compete on the same stage.
01 lost the first hand "metformin hydrochloride tablets 1.54 pieces, the national market is not enough for you to feed you.
" only one way, that is, innovation, "no innovation means death, innovation means life, especially in the current cash flow of some better generic companies, while there is cash flow as soon as possible to transform to innovative drugs to survive."
," cai Dongchen, chairman of The Stone Pharmaceutical Group, said of the plight and way out of China's traditional pharmaceutical companies.
, which began in 2018, has caused an unansponsed wave in China's pharmaceutical industry.
in this uphealy changing, the head of traditional pharmaceutical companies is undoubtedly the main character.
, unlike many multinational pharmaceutical companies, traditional pharmaceutical companies have a more active attitude in participating in the collection, conforming to policies, taking the initiative to reduce prices, and striving for the election.
the era of small profits from generic drugs, which is their active and passive choice to adapt to the situation.
from the results, although there is pain but finally stabilized the situation.
four rounds of collection in the past, the head of traditional pharmaceutical enterprises, whether in the number of selected products or the selection rate, have opened the gap with small and medium-sized enterprises.
just finished the fourth batch of collection, the number of winning bids of traditional pharmaceutical enterprises ranked in the forefront, Qilu, Yangzijiang, shi medicine, Middle School, Fosun and so on have 6 varieties selected.
And in the third batch of the largest number of varieties, stone medicine and Qilu 8 varieties outside the whole, Huahai, Xinlitai, Haizheng the same 100% of the election, and Howson 6 in 5, Colum 5 in 4, on the drug 8 in 6, whether it is the quantity or the selection rate, the head of traditional pharmaceutical enterprises are performing well.
rely on greater mass and more mature experience, the head of traditional pharmaceutical companies in the collection of "undefeated."
but as Cai Dongchen said, the "quantity" brought by the collection is not the way to win after all, pay attention to research and development to quality, innovation to win is the way forward.
and in this respect, PD-1 is an example.
the fastest-growing and hottest target in immunotherapy, the PD-1 competition is fierce.
end of 2017, when Xinda Bio submitted its first domestic PD-1 listing application, 16 varieties of PD-1 had already submitted registration applications.
but looking back, 16 varieties belong to the traditional pharmaceutical enterprises not only very few, most are still hovering in the clinical application stage, there is progress only Hengrui.
of the four domestic PD-1 manufacturers currently listed in China are still only Hengrui.
a quarter of the total is the relative weakness of traditional pharmaceutical companies in research and development innovation compared to China's biopharma.
is not only a matter of time, but also a game of innovative research and development strategy and clinical research strength.
In an exclusive interview with E-Drug Managers in 2018, Hengrui Pharmaceuticals Chief Medical Officer Yan Jianjun said that although Hengrui is not the first domestic manufacturer to declare clinical trials, it is well prepared in the overall competitive landscape, regardless of the number of research, type or adaptation coverage is in the leading position.
first in the innovation transformation also helped Hengrui as a representative of traditional large pharmaceutical companies to become China's pharmaceutical market value leader.
, but looking at the Chinese traditional pharmaceutical enterprises as a whole, is undoubtedly a loss of first hand.
02 accelerated and accelerated under the difficult situation, these traditional drug companies have opened the "self-help" road, the core of which is speed and efficiency.
, which dominates the number of winning products and reports on every set, has recently made frequent moves in its innovative layout.
16th, the Lunar New Year, the good news came from SanTiago.
, Cend Therapeutics Inc. and Qilu Pharmaceuticals announced a partnership and licensing agreement to develop and commercialize Cend's research phase drug CEN-1 in Greater China.
will pay a $10 million prepaid licensing fee to Cend, which will qualify for milestones of up to $225 million and tiered double-digit royalties on product sales in the region.
CEND-1 (also known scientifically as iRGD) is a peptide that penetrates tumors and specifically activates the drug transport mechanism in solid tumors.
, more than 200 studies using Cend know-how have been done to provide unprecedented preclinical validation/proof of concept.
When combined with standard chemotherapy, CEND-1 showed good safety/tolerance and clinical activity in patients with metastatic pancreatic cancer, with an ORR rate of 59% (compared to 23%) and a medium treatment time of 7.4 plus months (VS 3.9 months).
it is understood that Cend plans to conduct random Phase 2 studies of pancreatic cancer and trials of other combination therapies in 2021 and to launch other adaptations in 2021 and 2022.
, external introduction/cooperation are two paths for pharmaceutical companies to build research and development competitiveness.
end of July 2020, Qilu Pharmaceuticals authorized the introduction of drugs in the field of bladder cancer, amounting to approximately US$35 million.
disclosed at the time that Qilu Pharmaceuticals had entered into an exclusive licensing agreement with SesenBio of the United States to formally obtain the development and sale rights for the company's new drug, the Vicineum project in Greater China.
, vicinium is known to be a new antibody drug coupled (ADC) for the treatment of non-muscular immersive bladder cancer (NMIBC) and other potential tumors.
2018, Vicinium was granted fast-track status by the FDA.
February 16 this year, Sesen Bio announced that the FDA had accepted Vicinium's application for listing of the aforementioned adaptation certificate and granted priority review eligibility, with the PDUFA scheduled for approval on August 18, 2021.
At present, the treatment of non-muscular immersive bladder cancer has attracted more than 20 domestic and foreign enterprises, including Roche, Merca East, BMS, Lilly, AstraZeneza, Baiji Shenzhou, Fudan Zhangjiang, Rongchang Bio and so on.
then, in October, Qilu Pharmaceuticals brought in a new high blood pressure drug, firibastat Greater China, from Quantum Genomics for $50 million to treat incurable/drug-resistant hypertension.
, the estimated number of people suffering from difficult-to-treat and drug-resistant hypertension in authorized areas is between 25 and 30 million.
the partnership, Quantum Genomics is preparing to launch a Phase 3 clinical trial to study the efficacy of frbastat as an antihypertensive drug in preparation for the launch.
pharmaceutical company plans to add China's refrufficic hypertension trial to global research.
by combing through the three transactions, the changes are visible to the naked eye.
From the stage of the introduction of drugs, from entering the market application stage of the drug, to phase 3 clinical, to the preparation of phase 2 clinical stage, Qilu pharmaceutical product introduction is moving closer to the early stage, such a shift is taking place in this batch of innovative accelerated traditional pharmaceutical companies.
unique, East China Pharmaceuticals opened the year to investors hit a "double gun."
February 18, East China Medicine issued two consecutive announcements.
acquired an exclusive clinical development and commercial interest in PRV-3279, an innovative drug, for $189.5 million, and a 100% stake in High Tech, a Spanish EBD energy source equipment company, for up to 85 million euros.
the company's share price had risen more than 30 per cent in the first five trading days as of the date of writing, far outsized its peers, according to Tonghuashun Data.
, the PRV-3279 is a dual-specific antibody targeting CD32B and CD79B.
, the PRV-3279 clinical trial to block systemic lupus erythematosus (SLE) is currently under way in the United States and is in Phase 1.
, PRV-3279 has the potential to prevent or reduce immunogenicity in biological therapy, which is still in its preclinical stage.
in addition to the pharmaceutical layout, East China Pharmaceuticals is also the most comprehensive domestic non-surgical products pipeline layout of medical and American manufacturers, this acquisition will enable the company in the non-surgical mainstream medical products to carry out full coverage.
recently, East China Pharmaceuticals has just introduced an Ovarian Cancer Phase 3 Clinical Research ADC product from ImmunoGen for exclusive clinical development and commercialization interests in Chinese mainland, Hong Kong, Macau and Taiwan.
deal totaled more than $300 million, including a down payment of $40 million and a potential milestone payment of $265 million.
In fact, as early as 2018, East China Medicine began to implement the second major transformation, when East China Medicine in boston and Silicon Valley has set up a joint scientific research office, and publicly said that to continue to increase research and development investment, accelerate the research and development of innovative drugs and external introduction efforts, and strive to introduce 1-2 new overseas drugs each year.
2019, East China Pharmaceuticals will focus on self-built research and development, according to the disclosure of the company's research and development expenses for the year invested 1,055 million yuan, up 49.14 percent year-on-year, accounting for 10 percent of the pharmaceutical industry revenue;
2020, the company's focus will be slightly on external introductions and collaborations, with data showing that its Q3 research and development spending in 2020 will be slightly lower than in the same period last year, but has been effective in BD expansion, with the introduction of a number of products to quickly replenish pipelines.
it is understood that the company completed the formation of the BD team in the first half of 2020 and the introduction of a number of products in the second half of the year, including the aforementioned α-ADC products, Somalutide similars (expected to be declared IND in 2021), Usnu monoantigen similars (planned to start phase 3 clinical trials early this year).
driven by the innovation dividend, it is not only the traditional pharmaceutical giants who have been awakening in recent years, but even Hengrui Pharmaceuticals, which has always attached importance to research and development, that are feeling the pressure of competition.
On February 8th, Hengrui Pharmaceuticals announced a $20 million equity investment in the company to acquire a joint development interest and exclusive commercialization interest in Greater China for the company's Class 1 new drug, PI3k inhibitors (code name: YY-20394).
the product filter lymphoma adaptation certificate in China has been carried out to phase 3 clinical, the United States has just entered phase 2, and 3 adaptation certificates are also more than 1 stage.
, according to Hengrui announced that there are currently 3 foreign PI3K inhibitors approved for market, but the above products have not been approved for listing in China.
There are at least 7 pharmaceutical companies in China, such as Stone Pharmaceutical Group, Xinda Bio, Sanhe Pharmaceuticals, Zhengda Tianqing and Hutchison Whampoa, etc. are conducting clinical trials of PI3k python inhibitors, the vast majority of which are in phase II clinical trials, Bayer's PI3k inhibitor copanlisib in China for the treatment of non-Hodgkin's lymphoma has entered Phase III clinical.
the new normal for the accelerated innovation model of traditional pharmaceutical companies, with a high-intensity license in? Several industry insiders have previously said that in the future independent research and development and license in must complement each other, and long-term accompanying, in the coming period, as a basic model of China's new drug research and development companies.
2021 be a key year for the innovative layout of traditional pharmaceutical companies? "The 2021 Chinese medicine BigPharma, Biopharma and Biotech will meet each other, " Xu Jiaxuan, chief analyst of Henyep Securities' pharmaceutical industry, said in a preview for the start of the year.
said that the Chinese-style Big Pharma business is still mainly in the domestic market, in the full play of domestic channels, resources, under the premise of taking into account overseas business.
the future development of overseas Biotech and other companies excellent products in China's research and development and sales rights, to help consolidate their leading position.