Domestic innovation medicine evidence -based "milestone"!Zibutoni related studies were published in high scores of "Liuye Knife · Oncology"!

Recently, the BTK inhibitors independently developed by Baiji Divine Divine Phase III Sequoia study mid -term analysis data was published in the top international journal "The Lancet Oncology" magazine. Niger first -line treatment of large -scale research on chronic lymphocyte leukemia (CLL)/small lymphocyte lymphoma (SLL).

The results of this study not only confirmed the "head -to -head" clinical data to confirm the leading position of Zibntinib's "similar type", and strongly supported Zabitinini as a new high -efficiency and low toxic choice for the first -line treatment of CLL/SLL. It provides solid evidence -based medical evidence for global disease treatment, and marks that the international academic session has given high recognition of this heavy research results, leading the exploration and practice of China's international innovative drug internationalization.

For this mid -term analysis data, you can get high scores at the world's top academic journals. Sequoia studies the global Leading Pi, international famous chronic leukemia and inert lymphoma experts, and Professor Constantine Tam professor of hematology at Monash University, bluntly, Zibuti and China Innovation The major progress of drugs is getting the attention of the international academic and industry. "Studies have proved that Zibntinib has a significant benefit, better safety performance, and more suitable for long -term stable treatment; in addition, in the past," Liuye Knife · Oncology "was mainly the international multi -center clinical of European and American companies. With the rapid improvement of Chinese enterprises, "Liuye Knife · Oncology" published this study also fully demonstrated the research strength of Chinese innovative medicines. "

01

Cardiovascular safety advantage is prominent

Give patients long -term survival

CLL has a high heterogeneous, and the previous standard treatment BR scheme (bentamodo Stein+Lipchen Mipide) has limited effects and high severe adverse events (AES) incidence (AES) cannot meet the urgent urgent of patients with CLL/SLL patients. Clinical needs. After the BTK inhibitor came out, CLL fully entered the Chemo-free era.

Professor Constantine Tam pointed out that Sequoia's research is the first study in the front line to compare Zabitinib and the current standard chemotherapy solution. The results show that it is not only better than traditional immunochemage schemes, but also has advantages in drug toxicity and patient tolerance; Studies have found that the incidence of atrial fibrillation in Zibardini is very low. Compared with the previous generation of BTK inhibitors, cardiovascular events, especially atrial fibrillation, have always worried about doctors and patients. Zibubininnie over overcome this problem.

In Western countries, the average diagnosis age of CLL is 72 years old, and 89%of patients have at least one kind of complication during diagnosis. These complications include joint disease, hypertension, heart disease, respiratory disease, diabetes, etc.; In addition, in addition With the extension of the clinical treatment of tumor, the risk of cardiovascular complications represented by atrial fibrillation is also increasing. Because of this, it is very important to pay attention to cardiovascular -related incidents of CLL patients.

SEQUOIA studies China's Leading Pi, Professor Li Jianyong, the Hematology Department of the First Affiliated Hospital of Nanjing Medical University, and the Pukou Slow Discipline Center of the People's Hospital of Jiangsu Province, said that most of the patients with CLL are aging patients, and they need to be treated with lifelong norms. Large, cardiovascular incidents are particularly valued. "Sequoia studies confirmed the excellent effect and good safety of Zibitinib. By optimizing the choice of BTK inhibitors, CLL/SLL can be converted into chronic disease management, so that more slow dumpling patients can survive for a long time."

Sequoia research data shows that Zabitinib's 24 -month no progressive survival rate increased by 16%(85.5%vs 69.5%) compared with the BR standard scheme, reducing the risk of disease progress by 58%; Zibutinib is better than the BR solution; existing evidence supports Zibntinib more than Ibotinib to have less decisive toxicity, reducing the risk of arrhythmia, and reducing cardiovascular risk.

With the announcement of the global "head opposite" research data of the domestic innovative pharmaceutical company Baiji Shenzhou Zibutinib, the clinical medication of the BTK inhibitor is about to enter a new stage. Thanks to special designs, Zabitinib can form a lasting suppression of BTK. Compared with the first -generation BTK inhibitor, it reduces the incidence of some specific cardiovascular events such as atrial fibrillation.

As a milestone study, Sequoia research directly established a very important position in Zabitinib in slow first -line treatment. As of now, including the "Diagnosis and Treatment Guidelines for Chronic lymphocytic leukemia/small lymphocyte lymphoma" (2022 edition), and 2022 CSCO guide, Zibuti is preferred as the first -line standard treatment plan. As a priority recommendation for the slowness of the first governance, Butini fully confirms the international recognition of Zibitinib.

02

Evidence -based medical evidence evidence

Promoting slow -lening patients in the world

Centered on patients and meets unsatisfactory clinical needs, it must be guided by evidence. The influence factor (IF) of academic journals reflects the annual average number of references of articles published in the past two years: the higher the influence, the more important the journal status, and the prestige is more lofty, which means that the clinical application research of drugs means the follow -up of the research of drugs. The evidence is more authoritative.

This time, Sequoia has been completed in 14 countries and regions around the world and a total of 153 centers. With a wide range of global distribution, the "head opposite" compared BR standard solution design, with breakthrough clinical data, he has won the "Liuye knife · "Oncology" magazine, obtained a high score of the real -time impact factors of 54.433. This is the highest score of Chinese hematological tumor innovation drugs so far, which has provided solid evidence -based evidence for Zabutinib to obtain the global market recognition, which confirms Zibu alchemy Niger's leading and benchmarking role in high -quality evidence -based medicine. The Zibutinib (product name: Berye Aiza®) independently developed by Baiji Shenzhou is the new generation of BTK inhibitors. The optimized Zabitinib can maximize the BTK share and minimize the TEC, EGFR, HER2 The suppression of kinases, thereby reducing the occurrence of adverse reactions of traditional Chinese drugs in the treatment process.

The field of medicine, the number of patients with approved indications, the clinical value of drugs, whether the clinical treatment is blank, whether it has high -level evidence -based evidence and other factors, which determines the prospect of drugs in the global market. Zibutini has carried out three large -scale global studies three large -scale three -phase global research in ASPEN, Alpine, and Sequoia. Following international multi -center and high standard design, all are head -to -head designs. ), Hezanda Minden-Lipchen monoclonal anti-anti-anti-treatment plan (immunochemotherapy) initiated challenges, successfully proved his similar optimal ability, and laid a solid foundation for internationalization.

SEQUOIA research mainly contributes researchers and deputy director of Henan Cancer Hospital, Professor Zhou Keshu, said that as a new type of BTK inhibitor, Zibutinib has better safety compared to a generation of BTK inhibitors. Regardless of the alpine research on the recurrence and difficulty CLL, or the Sequoia study that focuses on the first governance CLL, these "head -to -head" studies have fully confirmed that the efficacy of Zibntinib is better. In terms of drug rates and bleeding risks, Zibitinib is better.

There is no border of the disease, the patient has no borders, and the development of drugs with better efficacy and safety, and high -level evidence -based exploration is looking for a way for patients around the world. In the past, the clinical experience of domestic innovative drugs often required the overseas experience of imported drugs. This "convention" is rewritten by the R & D and innovation of Zibntinib.

Professor Yi Shuhua of Sequoia studied PI, Professor Yi Shuhua of the Institute of Hematology Hospital of the Chinese Academy of Medical Sciences believes that Sequoia is a large -scale phase III clinical data from the original BTK inhibitor in China. From the front line, we can provide them with more evidence. "In the past, similar studies were basically white. Now more Asian breed data, more guiding value."

Zibutinib is one of the representative results of the global operation system of the Baiji Shenzhou. Today, Zibutini has conducted more than 30 clinical trials in more than 25 countries. Nearly 4,000 subjects in the group, of which more than 3,000 were from overseas. After the global market is approved by a number of adaptive diseases, more than 40 new drug listing applications for multiple indications are in the review of drugs and politics, contributing Chinese wisdom and Chinese power to global patients.

03

"Beginning in China, facing the world"

Help Chinese innovative medicine to the world

Innovative drugs are typical difficulty in the sea. All pharmaceutical companies know that overseas markets are the promise of innovative drugs, but to complete the organizational transformation and strategic transition of organizational transformation and strategy needs to be completed. Compared with the "transformation of internationalization" that domestic pharmaceutical companies often talk about, Baiji Shenzhou has regarded internationalization as the core strategy of the enterprise since its establishment, which has closely surrounded the goals of "starting in China and facing the world" to create Organizational structure and core competitiveness.

With the footsteps of the transformation and upgrading of Chinese pharmaceutical innovation, Zibutinib's clinical exploration has been along the way, starting with the earliest start-up global multi-centers Ⅰ/Ⅱ AU-003 research, and the phase II clinical study in China " The 206 project "incorporates this new BTK inhibitor into the international academic field of vision and the global industrial ecology.

Professor Li Jianyong believes that Zibutini is a veritable model of Chinese innovative medicine academic research. "This Sequoia study has been clinically clinically clinical from the beginning, and has received the support of many internationally renowned experts. The evidence -based medical evidence is solid. It is a great determination and a big deal that is not lost in the world and does not lose."

Baiji Shenzhou said that, as a global biopharmaceutical technology company, it has launched the layout of many countries worldwide and a forward -looking clinical experimental design, which has also laid a solid global academic foundation for the company; Multi -domestic and foreign experts work together to continue to build Chinese clinical research and global medicine integration, and develop more high -quality global innovation medicines.

In the overseas market, Zabitini was approved in the United States in November 2019 to achieve the "zero breakthrough" in China's new anti -cancer drugs. This huge success is by no means a good hand or God's pen. It is the success of the mature globalization system of Baiji Shenzhou, and it is the success of the industrialization process of the continuous improvement of the globalized new drug research and development of Baiji Shenzhou.

In fact, an innovative pharmaceutical company participating in global competition must fundamentally define itself as a global company, review the entire industry's pattern from a global vision, and completely build every key with the standards and requirements of global markets and requirements The team, strategy and execution capabilities in the business link may not be able to win in the same competition with international pharmaceutical companies, and even have a place to win, and eventually have a place in the global pharmaceutical industry. On July 26, The Galien Foundation announced the list of candidates for the 2022 PRIX Galien USA AWARDS. The Zibutini of Baiji Shenzhou was selected for the best biotechnology product award for the first time. The Galen Award, known as the "Nobel Prize in the Medicine Community" is recognized as the highest honor in the pharmaceutical and biomedical industry, which commended the outstanding scientific innovation to improve human health.

The internationalization of going to sea will be a key breakthrough path for innovative pharmaceutical companies to return to "source innovation" and realize the closed -loop of the global industrial chain from R & D to sales. The high -quality and differentiated advantages of product -based medicine are the essence of the differentiated requirements of different international regulatory agencies, and it is also the basis and foundation of innovative drugs to participate in global innovative drug development. For those, the leading practices of High -quality evidence -based medicine in Baiji Divine Divine, which boosted the confidence of China's innovative pharmaceutical industry.

Edit: Chen Shuwen

- END -