Through Asymchem’s support, Jianer Sheng (Zhuhai) Obtains Clinical Approval for the World’s First GMDTC Drug
November 29th- China’s CDE’s official website showed that GMDTC for injection submitted by Jianer Sheng Pharmaceutical Technology Co., Ltd. was granted an implied license for clinical trials. Asymchem and its subsidiary, Clin-Nov Medicals, provided one stop GXP services to this project including API, formulation, clinical study design and IND filing.
Asymchem Awarded the 5th, “Made in China Invisible Champion”
Asymchem was recently featured in the 5th “Made in China Invisible Champion” listing, in recognition of its status as a leading global CDMO. Asymchem contributes to the acceleration of clinical study and commercial manufacturing by providing one-stop CMC and efficient and high-quality R&D and manufacturing services to pharmaceutical and biotech companies throughout the drug lifecycle. In the future, the company will continuously contribute to technology innovation, provide leading customized CDMO solutions, and play a key role in global pharmaceutical ecosystem.
Mirati Receives FDA Approval for KRAZATI, the World’s 2nd KRAS Inhibitor
December 12th- Asymchem’s client Mirati Therapeutics announced that the FDA has accelerated approval of KRAZATI (Adagrasib) as a targeted therapy option for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
Asymchem Successfully Delivered Another Liposome Project
December 15th- Asymchem’s Drug Product Department successfully delivered another liposome project after overcoming a series of technical challenges in liposome’s process scale-up. Drug Product is an important step in Asymchem’s GXP one-stop strategy. Asymchem’s Drug Product Department will always be technology-driven, professional and innovative for the purpose of adding value to CDMO services
Asymchem’s Independently Developed Method for The Continuous Synthesis of Ethoxymethylenemalononitrile Obtained A Patent (Cn113956209b) from CNIPA
Asymchem’s self-developed method for the continuous synthesis of ethoxymethylenemalononitrile was granted a patent (CN111072518B) by the China National Intellectual Property Administration. This invention achieves the goal of continuous production of ethoxymethylenemalononitrile by taking advantage of continuous reaction equipment with the continuous substitution reaction of malononitrile, triethyl orthoformate and acetic anhydride. Compared with the conventional batch reaction, safety increases drastically, higher yield, and scale-up production could be achieved.
Recent Fixed Asset Assessment
The construction of Asymchem TJ plant is on track
The construction of Asymchem TJ plant is advancing in an orderly manner.
The following has been completed:
- The R&D center of CSBT in west plant (TJ4)
- R&D/analysis lab which includes 5L and 50L equipment
- The laboratory of CMMD in west plant (TJ4)
The following is under construction:
- The CNC area of the TJ4 CMMD production plant is expected to come on-line in mid-January, while the D-level area is expected to come on-line at the end of February.
- 90% of the construction work of the API4 building on the north side of TJ3 has been completed and is expected to be delivered in February 2023.
- The completion rate of the Oligo joint venture plant is 58%. The infrastructure works of each unit, including the comprehensive building, R&D center, power station, warehouse, modules and sewage station, are completed and expected to be completed in April 2023.
Clin-Nov Medical Business Progress
Clin-Nov Helps Beijing Kangming Haihui’s Original Drug Officially Obtain CDE Clinical Trial Approval
November 14th – The official website of CDE showed that KMHH-03 for injection, a new class 1 chemical drug submitted by Beijing Kangming Haihui Biotechnology Co., Ltd. was approved for phase I clinical trial. The proposed indication for the drug is “Metastatic breast cancer.” As a technical and academic leading CARO, Clin-Nov was in charge of the preclinical project management and registration services of the Phase I clinical trial application.
Clin-Nov’s Indispensable Contribution to The Success of The Phase III Clinical Study of the Centrum Sublingual Tablets
December 1st- Centrum Pharmaceutical Group announced that the Phase III clinical study of Centrum Sublingual Tablets, a multicenter, randomized, double-blind, parallel, placebo-controlled clinical study for the treatment of acute ischemic stroke, was born out of its partnership with Nanjing Nintan New Drug Technology Co. In this project, Clin-Nov ‘s Statistical Department acted as the DMC statistical support team, independently programming the statistical charts required for DMC data review and taking responsibility of the DMC meeting organization and coordination.
The Great Success of Clin-Nov’s New Years Party in Toronto
December 11th- Clin-Nov Boston Corporation successfully held an New Years Party at Bayview Golf & Country Club, where North American pharmaceutical colleagues, investment community leaders and senior executives in academia assembled here to discuss hot research topics, the tendency of future development and the opportunities for cooperation.
A Series of Lectures on The Analysis and Outlook of Data Validation Rules was Launched by Clin-Nov
December – A series of lectures on the analysis and outlook of data validation rules was delivered by Clin-nov, Certara Corporation, and Source Capital Information Technology Co. The event invited domestic industry experts and senior experts in the industry to give a comprehensive interpretation based on the latest regulations and guidelines. The lectures also included requirements on clinical trial data validation and submission, combined with the experts’ years of experience in the industry, and to assist pharmaceutical companies to ensure the compliance and integrity of clinical trial data.
Newly Joined Executives
Mr. Guang Yang officially joined Asymchem as Executive Director Research Chemist of Center of Synthetic Biology Technology（CSBT）on December 16, 2022. He will report directly to Asymchem’s Vice General Manager Ms. Na Zhang. In this position, he will be responsible for formulating and implementing the department’s work indicators according to the company’s development strategy in synthetic biology. Among other responsibilities, he also leads the team to tackle key projects and technologies, related research and development work, and providing technical guidance to the department’s personnel.
Mr. Guang Yang graduated from China Agricultural University, obtained a master’s degree in microbial physiology and genetic metabolism engineering in 2003 and a doctor’s degree in 2006. From 2006 to 2014, he was engaged in research in Tsinghua University, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences, and Massachusetts Institute of Technology. From 2014 to 2022, he served as the Chief Scientist of Canada Yigen Biotek Company. He has obtained 5 authorized invention patents and published more than 10 articles in domestic and foreign academic journals. Mr. Guang Yang has demonstrated impressive academic records and accumulated rich industrial work experience in microbiology, metabolic engineering, enzyme engineering, biochemistry, industrial biotechnology, molecular biology, biopharmaceutics and related fields.
Ms. Jing An officially joined Asymchem as Senior Director of QC on December 8th, 2022, reporting to Deputy Vice General Manager, Dr .Weibin Chen. Ms. Jing will take charge of the overall work of Shanghai JinShan QC team according to the company’s strategic planning, promote the construction of QC system and the sustainable development of talent team, and ensure that QC operations continue to meet the requirements of cGMP and data integrity laws and regulations. She graduated from Harbin University of Commerce with a master’s degree in biotechnology. Ms. Jing An has generated more than 10 years of QC experience in pharmaceutical industry as well as rich work experience in QC laboratory startup and operations. She has worked for CStone Pharmaceuticals, WuXi Biologics, Innovent and other well-known companies in the industry.
GPCR Drug Discovery Summit | February 21-23, 2023 | Boston, MA
BIOCOM Partnering Conference | February 23- March 2, 2023 | La Jolla, CA
OPT Congress | March 13-14, 2023 | Boston, MA
DCAT Week | March 20-23 | New York, New York
Festival of Biologics | March 20-22, 2023 | San Diego Marina, CA
ACS Crossroads of Chemistry | March 26-30, 2023 | Indianapolis, IN
SCI Process Development Symposium | March 29-31, 2023 | Cambridge, UK
TIDES USA | May 7-10, 2023 | San Diego, CA
IOPC | June 5-7, 2023 | Milan, Italy
BIO Convention | June 5-8, 2023 | Boston, MA
BOS Basel | July 4-5, 2023 | Basel, Switzerland
Organic Process Research and Development Conference | October 2-4, 2023 | Barcelona, Spain
CPHI Worldwide | October 24-26, 2023 | Barcelona, Spain
VendorFest Cambridge | October 26, 2023 | Cambridge, MA
TIDES EU | October 30-November 1, 2023 | Amsterdam, Netherlands
BOS Manchester | November 28-29, 2023 | Manchester, UK