[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test preparation Telmisartan Amlodipine Tablets (Specification: 80 mg/5 mg) and the reference preparation (Shuangjia®) (Specification: 80 mg/5 mg) in healthy Chinese adult subjects in the fed state

主要试验目的：研究餐后状态下单次口服受试制剂替米沙坦氨氯地平片（规格：80 mg/5 mg，Pfizer Pharmaceuticals Limited（辉瑞制药有限公司）生产）与参比制剂替米沙坦氨氯地平片（双加®，规格：80 mg/5 mg；Boehringer Ingelheim Pharma GmbH & Co. KG生产）在中国健康受试者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂替米沙坦氨氯地平片（规格：80 mg/5 mg）和参比制剂替米沙坦氨氯地平片（双加®）（规格：80 mg/5 mg）在中国健康受试者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetic characteristics of the test preparation Telmisartan Amlodipine Tablets (Specification: 80 mg/5 mg, produced by Pfizer Pharmaceuticals Limited) and the reference preparation Telmisartan Amlodipine Tablets (Shuangjia®, Specification: 80 mg/5 mg; produced by Boehringer Ingelheim Pharma GmbH & Co. KG) in healthy Chinese subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objective: To study the safety of the test preparation Telmisartan Amlodipine Tablets (Specification: 80 mg/5 mg) and the reference preparation Telmisartan Amlodipine Tablets (Shuangjia®) (Specification: 80 mg/5 mg) in healthy Chinese subjects.

Start Date05 Nov 2023

Sponsor / Collaborator

Huizhi Pharmaceutical (Dalian) Co., Ltd.

CTR20230590 / CompletedPhase 1

一项在20例健康中国受试者中于餐后情况下进行的关于Pfizer Pharmaceuticals Limited（中国）生产的尼麦角林片10 mg和Pfizer Italia S.R.L.（意大利）生产的Sermion®（尼麦角林，10 mg）的开放性、随机、单剂量、双交叉的生物等效性研究

[Translation] An open-label, randomized, single-dose, double-crossover bioequivalence study of nicergoline tablets 10 mg manufactured by Pfizer Pharmaceuticals Limited (China) and Sermion® (nimergoline, 10 mg) manufactured by Pfizer Italia S.R.L. (Italy) in 20 healthy Chinese subjects under fed conditions

在健康中国受试者中于餐后情况下评价尼麦角林片10 mg（Pfizer Pharmaceuticals Limited，中国）和Sermion®（尼麦角林，10 mg）（Pfizer Italia S.R.L.，意大利）的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。

[Translation]

To evaluate the absorption rate and extent of nicergoline tablets 10 mg (Pfizer Pharmaceuticals Limited, China) and Sermion® (nicergoline, 10 mg) (Pfizer Italia S.R.L., Italy) in healthy Chinese subjects under fed conditions and to assess whether the two formulations are bioequivalent.

Start Date17 Aug 2023

Sponsor / Collaborator

Huizhi Pharmaceutical (Dalian) Co., Ltd.

CTR20230588 / CompletedNot Applicable

一项在20例健康中国受试者中于空腹情况下进行的关于Pfizer Pharmaceuticals Limited（中国）生产的尼麦角林片10 mg和Pfizer Italia S.R.L.（意大利）生产的Sermion®（尼麦角林，10 mg）的开放性、随机、单剂量、双交叉的生物等效性研究

在健康中国受试者中于空腹情况下评价尼麦角林片10 mg（Pfizer Pharmaceuticals Limited，中国）和Sermion®（尼麦角林，10 mg）（Pfizer Italia S.R.L.，意大利）的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。

[Translation]

To evaluate the absorption rate and extent of nicergoline tablets 10 mg (Pfizer Pharmaceuticals Limited, China) and Sermion® (nicergoline, 10 mg) (Pfizer Italia S.R.L., Italy) in healthy Chinese subjects under fasting conditions and to assess whether the two formulations are bioequivalent.

Start Date10 Aug 2023

Sponsor / Collaborator

Huizhi Pharmaceutical (Dalian) Co., Ltd.

100 Clinical Results associated with Huizhi Pharmaceutical (Dalian) Co., Ltd.

0 Patents (Medical) associated with Huizhi Pharmaceutical (Dalian) Co., Ltd.

Literatures (Medical) associated with Huizhi Pharmaceutical (Dalian) Co., Ltd.

01 Feb 2024·Translational Cancer Research

Combinatory glycoengineering of monoclonal antibodies and its application in cancer therapy: a narrative review

Review

Author: Tian, Peilin ; Wang, Siyuan ; Tian, Huairu ; Xing, Yiwen ; Zeng, Yuan

Background and ObjectiveThe application of immunotherapy, especially in terms of recombinant monoclonal antibodies (mAbs), is a revolution in the pharmaceutical industry field. Glycosylation plays an essential role in the structures and functions of mAbs, which must be carefully monitored and designed throughout their entire lifespan to ensure safety and efficacy. This review aimed to summarize the current status of the glycoengineering of mAbs for providing reference for the pharmaceutical industry. The application of glycoengineering of mAbs in cancer therapy will also be discussed in this article.MethodsWe searched the PubMed/MEDLINE database to identify studies published between 1970 and 2023 that investigated glycoengineering of recombinant mAbs and its applications. The major findings of these studies were summarized.Key Content and FindingsThis article reviews the relationship between glycosylation profiles and antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), shelf-life, and other properties of mAbs. Furthermore, the rational design of glycosylation profiles provides solutions to the unmet needs of new drug development and biosimilar manufacturers. This review also emphatically describes various feasible strategies to optimize the glycosylation pattern in biomanufacturing reported in recent years, especially the approaches of combinatory glycoengineering explored in this field. Finally, we share examples of glycoengineering of mAbs applied in cancer therapy.ConclusionsGlycan modifications have been achieved through genetic and metabolic glycoengineering. A better understanding of the interplay between cells and the exogenous environment help the combinatorial strategy for glycoengineering in precise control mode. Furthermore, new high-tech approaches for glycoengineering are leading biological engineering and biotherapeutics to a new stage.

01 Jun 2023·Clinical pharmacology in drug development

Pharmacokinetics and Bioequivalence of Fluconazole Capsules Manufactured in France and China in Healthy Chinese Participants: Open-Label, Randomized, Single-Dose, 2-Way, Crossover Bioequivalence Study Under Fasted and Fed Conditions.

Article

Author: Chen, Naihan ; Wei, Hua ; He, Qing ; Liu, Shixue ; Ma, Ying ; Peng, Ao

This was an open-label, randomized study in healthy Chinese participants to assess the bioequivalence of 2 fluconazole 150-mg capsules under fasted and fed conditions. The study consisted of 2 treatment periods, separated by a 14-day washout period. Thirty-six participants were enrolled, with 18 participants each in the fasted and fed groups. In each treatment period, participants received a single oral dose of the test or reference fluconazole 150-mg capsule. After washout, participants received the alternate treatment. Blood samples for pharmacokinetic analysis were collected from 1 hour before dosing to 72 hours after dosing. The median plasma concentration-time profiles were similar for both treatments under fasted and fed conditions. Bioequivalence of fluconazole between the 2 capsules was demonstrated as 90% confidence intervals of the geometric mean ratios for the maximum plasma concentration and area under the plasma concentration-time curve from time 0 to 72 hours after dosing under fasted and fed conditions were within the acceptable range of 80%-125%. Overall, 7 participants reported at least 1 treatment-emergent adverse event; all were mild in severity. No serious adverse events or deaths were reported. The test fluconazole capsule was bioequivalent to the reference capsule, and a single dose was well tolerated. Clinicaltrials.gov ID: NCT03621072.

01 Jan 2023·TH Open

The Saudi Consensus for the Management of Cancer-Associated Thromboembolism: A Modified Delphi-Based Study

Article

Author: Almoomen, Abdualkreem ; Warsi, Ashraf ; Alsheef, Mohammed ; Osman, Ahmed ; Bazarbashi, Shouki ; Owaidah, Tarek ; Alfraih, Feras

Abstract Background Cancer is a well-known risk factor of preventable thromboembolic disease. This study aims to provide guidance on the prevention and management of cancer-associated thrombosis (CT) that tailors prophylactic and therapeutic options for medical and surgical oncology patients presenting to health care settings in Saudi Arabia. Methods The present consensus was developed in concordance with the modified Delphi-based approach, which incorporates a face-to-face meeting between two voting rounds to gain experts' feedback on the proposed statements. All experts were either oncologists, hematologists, or hemato-oncologist with an active clinical and research profile in hemato-oncology. Results The experts highlighted that the comparatively high incidence of inherited thrombophilia among the Saudi population may account for a higher CT burden in the Kingdom than in other parts of the world. However, due to the lack of literature that assesses CT in Saudi Arabia, primary venous thromboembolism prophylaxis should be tailored according to a valid risk assessment of cancer patients and should be implemented in routine practice. For hospitalized medical oncology patients, the experts agreed that prophylaxis with low-molecular-weight heparin (LMWH) should be offered, regardless of the presence of acute illness. For ambulatory medical oncology patients, LMWH or direct oral anticoagulants (DOACs) prophylaxis should be offered for high-risk patients. Concerning surgical patients, they agreed that all oncology patients undergoing surgery should be offered thromboprophylaxis. In terms of secondary prophylaxis, the experts recommended continuing a prophylactic dose of anticoagulant (LMWH or DOAC), for an appropriate period depending on the cancer type and stage. Finally, they also provided a set of statements on management of CT in Saudi Arabia. Conclusion The present modified Delphi-based study combined the best available evidence and clinical experience with the current health care policies and settings in Saudi Arabia to build a consensus statement on the epidemiology, prevention, and management of CT.

News (Medical) associated with Huizhi Pharmaceutical (Dalian) Co., Ltd.

07 Aug 2023

·www.prnewswire.com

Ligandal Inc. Appoints Tushar Nuwal as Chief Operating Officer and Chief Business Officer

NEW YORK, Aug. 7, 2023 /PRNewswire/ -- Ligandal Inc., an early-stage genetic medicine biotechnology company, announces the appointment of Tushar Nuwal as Chief Operating Officer and Chief Business Officer. Mr. Nuwal brings 20 years of biopharmaceutical experience, including roles at small and large pharmaceutical companies. "We are elated to welcome Tushar to Ligandal. His experience in negotiating multi-billion-dollar pharmaceutical transactions and his drive to scale Ligandal's platform will be invaluable to our growth," said Andre Watson, Chairman & CEO of Ligandal Inc. Mr. Nuwal is a global pharmaceutical veteran. His leadership spans across R&D, manufacturing, product & launch management, operations, business & corporate development, licensing, portfolio, and commercial strategy. His most recent role was Vice President at Polypid Inc., where he led BD&L. Prior to that, he was Executive Director of BD&L at Sandoz, a $10 billion division of Novartis. Mr. Nuwal's career is marked by impressive achievements. He has successfully led and closed over $2 billion in transactions and launched products generating over $1 billion in annual revenue. His experience includes roles at Pfizer Pharmaceuticals, Endo Pharmaceuticals, Purdue Pharma, and Fresenius Kabi. Mr. Nuwal holds a B.S. in Chemical Engineering and Economics from Rensselaer Polytechnic Institute, an M.S. in Transactional & IP Law from Northwestern University, a post-graduate diploma in Finance from New York University, and is currently enrolled in a medical sciences certificate program at Harvard University. "I'm thrilled to join Ligandal, advancing our cell and gene therapy platform. I'm particularly inspired by Andre Watson, our Founder and a Forbes 30 under 30 recipient in Healthcare. I'm excited about collaborating with him and our world-class team. This includes Dr. Adam Stein, our Chief Scientific Officer and former mid-size pharma executive, and Dr. Daniel Fagbuyi, a Board Member, Chief Medical Officer, EVP of Government Affairs, former Obama Administration Biodefense & Public Health appointee, former advisor to HHS, FDA, & CDC, and a US Army War Veteran. Together, we'll scale the company's vision and mission," said Mr. Nuwal. About Ligandal – Ligandal is at the forefront of genetic medicine, focusing on innovative solutions for oncology, rare genetic disorders, and biodefense. Leveraging cutting-edge nanotechnology, Ligandal is committed to developing therapies that have the potential to transform lives and shape the future of medicine. IR & Media Contact: Robert Sereny [email protected] [email protected] +1 (718) 801-3773 SOURCE Ligandal

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