{"status":1,"msg":"\u8bf7\u6c42\u6210\u529f","data":[{"id":32,"column":"\u516c\u53f8\u65b0\u95fb","title":"Beijing Pancro participated in the collaborative innovation Alliance of Medical research in northern Anhui and attended the launching meeting","issue_data":"2022-01-14","content":"
On the morning of December 24, 2019, in the delicate and moist light rain of Bengbu, Anhui province, the launching meeting of Collaborative Innovation Alliance of Northern Anhui Medical Research was held.<\/p>\r\n\r\n
Bengbu medical college first and second affiliated hospital, fuyang city people's hospital, huaibei city people's hospital, suzhou city hospital, bozhou city people's hospital, drug companies, such as characters of taihe county people's hospital hospitals director, secretary, science and education section chief attended the meeting, boehner west Asia as a representative of the clinical trials cooperative enterprises also participate in the meeting.<\/p>\r\n\r\n
Opening speech delivered by Party Secretary Gao of Bengbu Medical College; Dr. Yang Zhiwei from Institute of Experimental Animals, Chinese Academy of Medical Sciences, Director Zhou Huan from The First Affiliated Hospital of Bengbu Medical College, and secretaries of all participating hospitals made enthusiastic and active discussions and sharing. Wang Hongju, president of the first affiliated Hospital of Bangmu Medical College, presided over the meeting.<\/p>\r\n\r\n
The conference drew up the constitution of the Alliance, which is a non-profit and regional social organization voluntarily composed of scientific research institutes, medical institutions and enterprises. Basic medical research on major diseases and rare diseases will be carried out based on scientific research institutes and medical institutions, with institutional and institutional innovation as the core, with complementary needs, combined advantages and cooperation. To carry out drug clinical trials and take the lead in building China's clinical research innovation system; To apply\/undertake national and local research fund projects; Conducting training and academic exchanges in clinical medicine and basic medical research; Promote the clinical application and transformation of research results.<\/p>\r\n\r\n
While carrying out basic research and improving clinical diagnosis and treatment skills, THE Alliance supports members to carry out various forms of clinical research in accordance with the Opinions on Encouraging clinical Trials issued by the National Health Commission and the Opinions on Encouraging Drug and Medical Device Innovation by Deepening the Review and Approval System issued by the General Office of the CPC Central Committee. Provide clinical trial institution building, design of experiment, GCP verification, recruitment, biometric and other services, in order to improve the whole clinical research level of wanbei quickly, creating new medicine clinical research system for the sustainable development of northern anhui, better service in medical science and technology innovation, and ultimately contribute to the health of China, anhui.<\/p>\r\n\r\n
<\/p>\r\n\r\n
<\/p>\r\n","source":"Pancro","create_time":"2022-01-24 15:17:47","abstract":"In our Beijing office, Sun Yat-sen University school of Pharmacy professor, Guangdong South China new drug innovation center chief scientist..."},{"id":35,"column":"\u516c\u53f8\u65b0\u95fb","title":"Beijing Panacro joins in Northern Anhui Alliance for Collaborative Medical Research & Innovation and attends the kick-off meeting","issue_data":"2019-12-26","content":"
It was raining lightly in the morning of December 24, 2019, when the kick-off meeting of the Northern Anhui Medical Research Collaborative Innovation Alliance was held in Bengbu, Anhui Province.<\/p>\r\n\r\n
The presidents, secretaries and heads of science and education divisions from the First and Second Affiliated Hospitals of Bengbu Medical College, the Fuyang People's Hospital, the Huaibei People's Hospital, Suzhou Municipal Hospital of Anhui Province, Bozhou People's Hospital, some pharmaceutical companies, Taihe County People's Hospital and other hospitals in Northern Anhui attended the meeting; and Panacro, as a representative of clinical trial partner companies also participated in this meeting.<\/p>\r\n\r\n
Mr Gao, secretary of the party committee of Bengbu Medical College delivered an opening speech; Dr. Yang Zhiwei from Institute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences, and Zhou Huan, Executive Deputy Director of the Clinical Trial Institute of the First Affiliated Hospital of Bengbu Medical College, as well as the presidents and secretaries of all participating hospitals made enthusiastic, active and practical discussions and sharing.<\/p>\r\n\r\n
President Wang Hongju of the First Affiliated Hospital of Bengbu Medical College presided over the meeting.<\/p>\r\n\r\n
During the meeting, the constitution of the alliance was drawn up, namely, the alliance is a voluntary, non-profit, regional social organization formed by research institutes, medical institutions and enterprises; with research institutes and medical bodies as the foundation, institutional and mechanism innovation as the core, the alliance will draw upon strengths from each other and cooperate to carry out basic medical research on major diseases and rare diseases; carry out drug clinical trials and take the lead in building the country's clinical study innovation system; apply for\/undertake national and local scientific research fund projects; carry out training and academic exchanges in clinical medicine and basic medical research; and facilitate the clinical application and transformation of research results.<\/p>\r\n\r\n
While conducting basic research and improving clinical diagnosis and treatment skills, the Alliance adheres to the Opinions on Encouraging the Implementation of Clinical Trials by the National Health Commission and the Opinions on Deepening the Review and Approval System to Encourage Innovation on Drug and Medical Device by the General Office of the CPC Central Committee, supports members to conduct various forms of clinical studies and provide services such as clinical trial institution building, trial design, GCP verification, subject recruitment and biostatistics, aiming to rapidly improve the overall clinical study level in Northern Anhui, create a new clinical research system for the sustainable development of medicine in Northern Anhui, and better serve medical science and technology innovation, thus ultimately contributing to the development of healthy Anhui and healthy China as a whole.<\/p>\r\n","source":"Panacro","create_time":"2022-03-24 16:32:50","abstract":"It was raining lightly in the morning of December 24, 2019, when the kick-off meeting of the Northern Anhui Medical Research Collaborative Innovation Alliance was held in Bengbu, Anhui Province."},{"id":37,"column":"\u516c\u53f8\u65b0\u95fb","title":"Warmly welcome Prof. Zhang Kejian to visit our company","issue_data":"2019-12-26","content":"
The presidents, secretaries and heads of science and education divisions from the First and Second Affiliated Hospitals of Bengbu Medical College, the Fuyang People's Hospital, the Huaibei People's Hospital, Suzhou Municipal Hospital of Anhui Province, Bozhou People's Hospital, some pharmaceutical companies, Taihe County People's Hospital and other hospitals in Northern Anhui attended the meeting; and Panacro, as a representative of clinical trial partner companies also participated in this meeting.<\/p>\r\n\r\n
Mr Gao, secretary of the party committee of Bengbu Medical College delivered an opening speech; Dr. Yang Zhiwei from Institute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences, and Zhou Huan, Executive Deputy Director of the Clinical Trial Institute of the First Affiliated Hospital of Bengbu Medical College, as well as the presidents and secretaries of all participating hospitals made enthusiastic, active and practical discussions and sharing.<\/p>\r\n\r\n
President Wang Hongju of the First Affiliated Hospital of Bengbu Medical College presided over the meeting.<\/p>\r\n\r\n
During the meeting, the constitution of the alliance was drawn up, namely, the alliance is a voluntary, non-profit, regional social organization formed by research institutes, medical institutions and enterprises; with research institutes and medical bodies as the foundation, institutional and mechanism innovation as the core, the alliance will draw upon strengths from each other and cooperate to carry out basic medical research on major diseases and rare diseases; carry out drug clinical trials and take the lead in building the country's clinical study innovation system; apply for\/undertake national and local scientific research fund projects; carry out training and academic exchanges in clinical medicine and basic medical research; and facilitate the clinical application and transformation of research results.<\/p>\r\n\r\n
While conducting basic research and improving clinical diagnosis and treatment skills, the Alliance adheres to the Opinions on Encouraging the Implementation of Clinical Trials by the National Health Commission and the Opinions on Deepening the Review and Approval System to Encourage Innovation on Drug and Medical Device by the General Office of the CPC Central Committee, supports members to conduct various forms of clinical studies and provide services such as clinical trial institution building, trial design, GCP verification, subject recruitment and biostatistics, aiming to rapidly improve the overall clinical study level in Northern Anhui, create a new clinical research system for the sustainable development of medicine in Northern Anhui, and better serve medical science and technology innovation, thus ultimately contributing to the development of healthy Anhui and healthy China as a whole.<\/p>\r\n\r\n
<\/p>\r\n","source":"Panacro","create_time":"2022-03-24 16:39:05","abstract":"It was raining lightly in the morning of December 24, 2019, when the kick-off meeting of the Northern Anhui Medical Research Collaborative Innovation Alliance was held in Bengbu, Anhui Province."},{"id":40,"column":"\u516c\u53f8\u65b0\u95fb","title":"New Year wishes from Chairman","issue_data":"2022-01-20","content":"
It was raining lightly in the morning of December 24, 2019, when the kick-off meeting of the Northern Anhui Medical Research Collaborative Innovation Alliance was held in Bengbu, Anhui Province.<\/p>\r\n\r\n
<\/p>\r\n\r\n
The presidents, secretaries and heads of science and education divisions from the First and Second Affiliated Hospitals of Bengbu Medical College, the Fuyang People's Hospital, the Huaibei People's Hospital, Suzhou Municipal Hospital of Anhui Province, Bozhou People's Hospital, some pharmaceutical companies, Taihe County People's Hospital and other hospitals in Northern Anhui attended the meeting; and Panacro, as a representative of clinical trial partner companies also participated in this meeting.<\/p>\r\n\r\n
<\/p>\r\n\r\n
Mr Gao, secretary of the party committee of Bengbu Medical College delivered an opening speech; Dr. Yang Zhiwei from Institute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences, and Zhou Huan, Executive Deputy Director of the Clinical Trial Institute of the First Affiliated Hospital of Bengbu Medical College, as well as the presidents and secretaries of all participating hospitals made enthusiastic, active and practical discussions and sharing.<\/p>\r\n\r\n
<\/p>\r\n\r\n
President Wang Hongju of the First Affiliated Hospital of Bengbu Medical College presided over the meeting.<\/p>\r\n\r\n
<\/p>\r\n\r\n
During the meeting, the constitution of the alliance was drawn up, namely, the alliance is a voluntary, non-profit, regional social organization formed by research institutes, medical institutions and enterprises; with research institutes and medical bodies as the foundation, institutional and mechanism innovation as the core, the alliance will draw upon strengths from each other and cooperate to carry out basic medical research on major diseases and rare diseases; carry out drug clinical trials and take the lead in building the country's clinical study innovation system; apply for\/undertake national and local scientific research fund projects; carry out training and academic exchanges in clinical medicine and basic medical research; and facilitate the clinical application and transformation of research results.<\/p>\r\n\r\n
<\/p>\r\n\r\n
While conducting basic research and improving clinical diagnosis and treatment skills, the Alliance adheres to the Opinions on Encouraging the Implementation of Clinical Trials by the National Health Commission and the Opinions on Deepening the Review and Approval System to Encourage Innovation on Drug and Medical Device by the General Office of the CPC Central Committee, supports members to conduct various forms of clinical studies and provide services such as clinical trial institution building, trial design, GCP verification, subject recruitment and biostatistics, aiming to rapidly improve the overall clinical study level in Northern Anhui, create a new clinical research system for the sustainable development of medicine in Northern Anhui, and better serve medical science and technology innovation, thus ultimately contributing to the development of healthy Anhui and healthy China as a whole.<\/p>\r\n","source":"Panacro","create_time":"2022-03-24 16:43:52","abstract":"It was raining lightly in the morning of December 24, 2019, when the kick-off meeting of the Northern Anhui Medical Research Collaborative Innovation Alliance was held in Bengbu, Anhui Province."},{"id":41,"column":"\u516c\u53f8\u65b0\u95fb","title":"Training of \u201cEmpowering The Managers\u201d by Panacro (2nd session)","issue_data":"2021-11-22","content":"
All employees from Panacro's management layer gathered in the beautiful Huangshan Mountain for the training of “empowering the managers” on a golden autumn day. In the training, we are honored to invite Mr. Zhang, who has 25 years of working experience in Huawei and holds the position of general manager in many overseas countries of Huawei, to give the lecture.<\/p>\r\n\r\n
In the first training session, Chris, Vice Management President of Panacro, gave us an insightful talk on the importance of corporate culture around "Panacro Manager Standards", "Echelon Building of Talents", "On-the-job Management", "Onboarding and Promotion" and other aspects. In the second training session, Mr. Zhang empowered the participants from several dimensions, including "the power of managers", "shaping and practicing of core values", and "the creation of corporate culture and competitive advantages".<\/p>\r\n\r\n
The training resonated with everyone, and all managers had their own feelings and insights, and they were willing to share them with other colleagues. From their feelings, we see the cohesiveness and combativeness of Panacro's management layer, and we believe that under their leadership, Panacro will have a team that can go into battle and win.<\/p>\r\n\r\n
Chen Jinxia Senior Project Manager<\/p>\r\n\r\n
It offers us a good opportunity to improve management ability and expand our horizons, and also made me deeply aware of the role a qualified middle-level management personnel play in the development of the enterprise and the importance of enhancing their management abilities when it comes to enterprise development".<\/p>\r\n\r\n
Among the training courses, the one that made my blood boil the was The Wolfish Management. It's uplifting and motivating. To create a wolfish culture, the leader, as the alpha wolf, is responsible for acutely capturing business opportunities, locking targets and formulating combat strategies, and the backbone of the wolf pack execute unconditionally and efficiently. Everyone shares out the work and cooperate with one another to finally achieve the goal.<\/p>\r\n\r\n
Panacro's core value of "constant self-criticism" represent a principle that not everyone can live up to. People are prone to seeing problems of others, while it is difficult to see their own.<\/p>\r\n\r\n
\r\nAs society and enterprises keep evolving, each of us can only develop ourselves and further promote the sustainable development of enterprises by insisting on self-criticism.<\/p>\r\n\r\n
The role and significance of the business level and management ability of the middle and senior management for the development of an organization is much more important than we can imagine. Therefore, we should continuously reflect on our work, enhance management awareness, and make much more efforts to enhance management ability in the future. Only by enhancing the understanding of ourselves can we realize our gaps; only through continuous learning and exploration, can we achieve high efficiency and high performance to better reach our goals. In the future, I will take the initiative to undertake more under the premise of completing my own work, and run towards the goal under the leadership of the alpha wolf.<\/p>\r\n\r\n
Feng Longyan, Director of Eastern Region<\/p>\r\n\r\n
Strengthen corporate culture. "Material will eventually run out, and only culture can live on". The construction of enterprise culture is an effective way to implement enterprise development strategy, improve the level of business management, and motivates employees to go further. Especially in the CRO industry, it needs more to rely on corporate culture to enhance the cohesion of employees, so as to unlock the potential of employees and maximize the value for the company by upholding the value of “customer-centric & striver first.<\/p>\r\n\r\n
Improve management system and enhance team execution. Competitiveness cannot be generated without execution, leading to development power of the enterprise out of the question. The company upholds the core value of “customer-centric & striver first. Under a comprehensive performance management system, we reasonably set goals, monitor the implementation, perform evaluation and feedback in an object way, so as to enhance the abilities of employees and the execution of the team.<\/p>\r\n\r\n
Zhao Yuping, Associate Medical Director<\/p>\r\n\r\n
The two sessions of manager training touched me a lot, and I have a strong sense that in Panacro, employees unite as one from top to bottom, the strategy can be put into real practice and the system is well-balanced.<\/p>\r\n\r\n
For managers, the first step is to raise the level of thought. There is regular output through self-learning and external training. At the same time, the managers should cooperate with the implementation of the company's system and continuously improve the team's internal job qualification system. At the corporate level, the managers should actively put implementation of the company's strategy in place. And respond to the company's "horse-racing" culture, so that the winners are motivated and the losers are convinced.<\/p>\r\n\r\n
The development of Panacro cannot be achieved without the hard work of all people in their respective positions. But a company needs to rely on organization and process if it is to walk further. As a saying goes, the camp of the army is fixed, while veterans leave and new recruits come in every year, just like running water. A fixed camp comes from a continuous cultural propaganda, a sound system and organization and a management process independent from human will.<\/p>\r\n\r\n
The managers play a decisive and driving role in the sinking of performance and profits. The performance indicators are decomposed at each level, and the targets are implemented to individuals, so that each employee can start from a company level, fully understand the performance assessment indicators and work hard to complete them, and finally maximum value of individuals.<\/p>\r\n\r\n
As inheritors of the corporate culture, and implementers of the company's strategy, the managers should have the ability to implement the company's strategy, the ability to continuously win battles and continuously improve the organization's combat effectiveness. The managers should highly recognize the company's corporate culture, and their daily management should strictly align with the company's core values and adhere to the company's corporate culture. The managers should take the initiative to become the main force in terms of the company's business undertaking, work in the main battlefield of front-line operations, demonstrate core competencies and consolidate the organization. At the same time, Panacro will also optimize the result-oriented salary system and promotion path, so as to activate the team's motivation and make Panacro a customer-trustworthy clinical CRO company with strongest execution!” Said Zhao Min, Founder and CEO of Panacro.<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:14:34","abstract":""},{"id":42,"column":"\u516c\u53f8\u65b0\u95fb","title":"Panacro Announces Professor Chow Shein-Chung from Duke University Joining as Chief Consulting Scientist","issue_data":"2022-07-02","content":"
On September 29, 2021, according to the CDE website, Bebetter Med' HDAC\/PI3K dual-target inhibitor BEBT-908 is proposed for inclusion in the breakthrough therapy list for the third-line treatment of relapsed or refractory diffuse large B-cell lymphoma (r\/r DLBCL).<\/p>\r\n\r\n
BEBT-908 is Bebetter Med's first HDAC\/PI3K dual target inhibitor proposed for inclusion in the breakthrough therapy list Panacro, entrusted by Bebetter Med, has engaged in CRO services such as medical R&D strategy development, medical monitoring, data management and statistical analysis since September 25, 201<\/p>\r\n\r\n
The technical team of Panacro responded quickly and solve the problems encountered in the clinical trials in a professional and efficient manner. In the NDA of breakthrough therapy, the medical division, data division and statistical division worked together to achieve a good presentation of the Phase IIa statistical analysis report and clinical study report in a short period of time, which was highly recognized by the sponsor and CDE.<\/p>\r\n\r\n
"Currently, five clinical studies have been initiated with BEBT-908, among which, Phase II clinical studies targeting a variety of hematologic tumors such as follicular lymphoma, chronic lymphocytic leukemia\/small lymphocytic lymphoma, Walden's macroglobulinemia, marginal zone lymphoma, and peripheral T-cell lymphoma have been initiated, and solid tumor indications are also under clinical exploration, and Panacro is honored to participate,”said Du Xiaojian, Chief Medical Officer of Panacro.<\/p>\r\n\r\n
In the future, Panacro, by leveraging its professional technical ability and quality service, will make persistent efforts to promote local innovative drugs to benefit the majority of patients as soon as possible!”<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:18:03","abstract":""},{"id":44,"column":"\u516c\u53f8\u65b0\u95fb","title":"Collaboration with Sponsor \u4e28Binhui Biopharm BS001 injection is highly effective in treating melanoma","issue_data":"2021-07-12","content":"
Recently, Binhui Biopharm announced that for BS001 injection, the first oncolytic virus drug candidate developed by the company's lysovirus (oHSV2) technology platform, a dose-expansion phase clinical trial in the melanoma indication is about to complete. The trial was conducted by Professor Guo Jun, Secretary General of the Chinese Society of Clinical Oncology (CSCO) and Chairman of the CSCO Melanoma Expert Committee, as the principal investigator (PI). Since its official launch at Beijing Cancer Hospital in October 2018, as of April 2021, clinical data showed that the objective remission rate (ORR) of BS001 injection for the treatment of melanoma reached 30%, the disease control rate (DCR) reached 50%, and the one-year survival rate (OS) was as high as 93%, showing excellent clinical efficacy, which is a good news to Chinese melanoma patients.<\/p>\r\n\r\n
As a partner CRO for the project, Panacro provides a full range of services for clinical studies of oncolytic virus (oHSV2). Since the start of this project in 2018, the clinical medicine and statistics teams of Panacro have worked closely with Binhui Biopharm and Beijing Cancer Hospital to scientifically design the clinical trial protocol and strictly ensure the professionalism and operability of the top-level design of this clinical study.<\/p>\r\n\r\n
The operation and execution team strictly followed the GCP specification and trial protocol, organized the implementation meticulously, and took full responsibility for the quality and progress of the clinical trial, ensuring that the clinical study procedures in this phase were compliant and the data were true and reliable.<\/p>\r\n\r\n
"The clinical progress of Binhui Biopharm Biolysis Virus(oHSV2) project take the lead in China, and as the CRO team for the design and implementation of the clinical trial project of BS001 injection for melanoma, Panacro is very pleased with the promising results obtained from the preliminary collaboration. The birth of a new therapy may change the landscape of the melanoma treatment market in China. The Panacro project team also demonstrated rigorous working attitude, professional knowledge base, and excellent execution ability. In the future, Panacro will continue to help promote the Binhui Biopharm Biolysis Virus (oHSV2) project and continue to provide high-quality clinical services for sponsors,” said Du Xiaojian, Chief Medical Officer, Panacro.<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:19:09","abstract":""},{"id":45,"column":"\u516c\u53f8\u65b0\u95fb","title":"Collaboration with Sponsor \u4e28 IND Application for Recombinant HPV15 (Escherichia coli) Co-developed by Chengda Biologics & BHGB Approved","issue_data":"2022-03-17","content":"
On March 14, 2022, The Notice of Approval of Drug Clinical Trial (Notice No. 2022LP00449) approved by the NMMP arrived, approving the IND application for recombinant 15-valent human papillomavirus vaccine (Escherichia coli) co-developed by Liaoning Chengda Biology Co. LTD (Chengda Bio) & Beijing Health Guard Biotechnology INC (BHGB).<\/p>\r\n\r\n
Panacro, entrusted by Chengda Bio, has engaged in CRO services such as medical R&D strategy development, medical monitoring, data management and statistical analysis, thus Facilitate the full life cycle management of the project.<\/p>\r\n\r\n
Cervical cancer is the second major malignancy in women, with which human papillomavirus (HPV) has a direct correlation. Through screening the dominant gene sequences of the target serotypes, constructing engineered strains of the target serotypes, developing detection kits and optimizing the protein purification process, the recombinant HPV15 (Escherichia coli) co-developed by Chengda Biologics & BHGB can prevent all high-risk HPV viruses and HPV 6\/11, which are highly associated with acromegaly.<\/p>\r\n\r\n
Panacro has begun to make deployment in vaccine since 2019, and as one of the initiators, we also led the establishment of the Clinical Branch of China Association for Vaccines, serving as the secretary-general unit. By leveraging professional technical capability and perfect vaccine clinical trial quality management and operation system, Panacro team provides high quality and efficient clinical trial services for vaccine development. In 2020, the core vaccine business of Panacro was officially operated independently in Suzhou office, which was highly recognized by the sponsors and partner organizations with its quality expert resources and on-site resources.<\/p>\r\n\r\n
“The IND application for recombinant HPV15 (Escherichia coli) co-developed by Chengda Biologics & BHGB was approved, congratulations! Panacro feels proud to have contributed to the clinical trial of HPV15 vaccine, which is the world's vaccine that has been formally submitted and accepted for clinical trial to date. We are all looking f highest-valent HPV orward to the its NDA, which will bring benefits to more women. Panacro will also focus on improving the clinical operations of vaccines and strive to provide better services for vaccine clinical studies in China".<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:22:01","abstract":""},{"id":46,"column":"\u516c\u53f8\u65b0\u95fb","title":"Collaboration with Sponsor \u4e28Clinical Trial of Fudan Zhangjiang Obeticholic Acid Tablets for Primary Biliary Cholangitis Treatment Completes First Subject Enrollment","issue_data":"2021-12-15","content":"
On December 13, 2021, Shanghai Fudan Zhangjiang Biomedical Co., Ltd (hereinafter referred to as "Fudan Zhangjiang") announced that the clinical trial of Obeticholic Acid Tablets (size: 5mg, 10mg) (hereinafter referred to as "the drug") developed by the company's subsidiary Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd for treatment of primary biliary cholangitis (PBC) has successfully completed the first patient enrollment in the clinical trial.<\/p>\r\n\r\n
The drug is a Farnesoid X receptor (FXR) agonist, a nuclear receptor expressed at high levels in the liver and intestine that plays a key role in the regulation of bile acid metabolism. The drug is a class 3 generic chemical drug with primary biliary cholangitis as its first target indication. This clinical study is a multicenter, randomized, double-blind, double-model, placebo-controlled bridging clinical trial evaluating the efficacy and safety of obeticholic acid tablets in the treatment of primary biliary cholangitis.<\/p>\r\n\r\n
As a CRO partner for this project, Panacro facilitates the full lifecycle management of the project and is involved in CRO services such as medical R&D strategy development, medical surveillance, project operation management, data management and statistics, and pharmacovigilance. In spite of the difficulty of the project and the small number of people eligible for program enrollment, the project team of Panacro actively responds to the pressure and adhered to the core value of "customer-centric & striver first" to propose practical solutions for the sponsors. At the same time, the project team maintains close communication with the study center, closely follows up with patients and conducts careful screening to ensure the patient pool. The Panacro project team were highly recognized by the sponsor by virtue of the rigorous working attitude and strong execution abilities.<\/p>\r\n\r\n
"This project is a breakthrough made by Fudan Zhangjiang in the patent restriction of the original drug, and the Panacro team is honored to contribute to its clinical trial. In the next project process, Panacro team will rise to the challenge and make leap progress through daily accumulations. We look forward to the early NDA submission of this drug to the market for the benefit of more people suffering from hepatobiliary diseases. Panacro will also continue to uphold its customer-centric philosophy and facilitate new local drugs at full speed to serve the patients as soon as possible.<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:24:59","abstract":""},{"id":47,"column":"\u516c\u53f8\u65b0\u95fb","title":"Collaboration with Sponsor \u4e28 PD-1 NDA by Lepu Biopharma Accepted by CDE","issue_data":"2021-07-06","content":"
PD-1 (pucotenlimab) is a novel humanized monoclonal antibody differentially designed to target PD-1, belonging to human IgG4\/Kappa subtype, with the introduction of S254T\/V308P\/N434A mutation in the Fc of IgG4 to extend the half-life. Its gains an advantage due to its design strategy of extended half-life and introduction of mutations in the Fc region using innovative differential antibody engineering technology, which is expected to reduce the number of doses, lower the cost of treatment, and further improve patient compliance with the drug.<\/p>\r\n\r\n
Panacro has partnered with Lepu Biopharma since 2019, provide whole-process services for the PD-1 pucotenlimab Phase II clinical study. As a CRO partner for this project, Panacro facilitates the full lifecycle management of the project and is involved in CRO services such as medical R&D strategy formulation, operation management, data statistics, pharmacovigilance and preparation of NDA filings.<\/p>\r\n\r\n
During the project process, Panacro’s project team adhered to the core values of "customer-centric & striver first", and united as one from top to bottom to overcome all challenges during project execution to ensure that the project was completed as scheduled. The Panacro project team were highly recognized by the sponsor by virtue of its scientific and rigorous attitude, project support expertise and operational efficiency and quality in the project implementation process.<\/p>\r\n\r\n
“NDA of PD-1 pucotenlimab by Lepu Biopharma was accepted by the CDE, and congratulations!Panacro is honored and proud to be involved in NDA of Lepu Biopharma’s first innovative drug.We wish the drug will be available soon and bring benefits to the patients with second-line and above melanoma.At the same time, Panacro will continue to work hard and practice its customer-centric philosophy to improve and accelerate the clinical projects for the sponsors,” said Mr. Zhao Min, Founder & CEO of Panacro.<\/p>\r\n","source":"Panacro","create_time":"2022-05-28 12:28:17","abstract":""}]}