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Shenzhen headquarters
14th floor, Block A, Jinxiu Phase III, No. 85 Hudipai, Songxuan Community, Guanhu Town, Longhua District, Shenzhen, Guangdong Province, China
ABOUT US
ABOUT US
COMPANY PROFILE
COMPANY PROFILE
1843, British scientist W. Brockedon, inspired by modern pencil manufacturing technology, invented modern tablets by pressing drug powders into molds.
1844, Irish surgeon Francis Rynd invented the world's first hollow needle, truly pioneering the history of modern injectable.
Today, the usage of oral drugs is ~62%, and the usage of injections is ~31%, together occupying ~93% of all human drugs, leaving all many other dosage forms only 7%.
In one word, they are the major methods we are using today.
1958, US Professor Alan Richard Wagner first proposed the concept of microneedle intradermal drug delivery technology. It is a revolutionary way to deliver drug candidates, via the maximum exposed surface area through the external skin route. It is painless and have minimal invasion of human organs because it will not reach anywhere deeper than human skin, so it should be a very compliant method to patients. An interesting fact is that lacking depth of needles does not mean less exposure this time while the ingredients passes through the lymphatic capillaries in the skin and eventually reach the circulatory system via human microcirculation system. Considering that all drugs are administered through the "skin" of some organs in human body (eg. gastric wall mucosa, intestinal mucosa, eye mucosa, other luminal mucosa, and surface skin), and the skin is the largest exposed organ which directly connecting the outside world, if we can achieve a painless and less invasive way through surface skin, this route should be very meaningful clinically, in order to reduce side effects (eg. gastrointestinal, first pass liver effects) and improve patient compliance.
Despite numerous scientists donated their investigations on microneedle transdermal drug delivery system (MN TDDS) since Professor Wagner, there are still a lot of CMC issues left in MN TDDS today to be challenged.
November 2020, 《Scientific American》 (an authoritative popular science magazine in US) selected 10 new technologies that are may change the world in 2020, and the MN TDDS is ranked as the 1st of all. This fully demonstrates that MN TDDS is extremely difficult, yet humans still have a strong desire and expectation to it, especially for the pharmaceutical industry.
BioQingLam is a high-tech enterprise specialized in soluble MN TDDS. We have a complete set of proprietary intellectual property rights related to MN TDDS, including but not limited to prescriptions, processes, equipment, and quality standards. We want to bring the change to the way of using drugs for all human being and have the potential to be the first one to achieve this goal with MN TDDS globally.
We have established a professional technical team in this niche field and successfully solved key CMC challenges such as drug loading, bioavailability, and content uniformity of MN TDDS.
We are oriented by delivery results and have tested our samples through animal models (such as rats, dogs, pigs, monkeys) and ultimately human studies, achieving drug delivery results that comply with regulatory requirements.
We have established small-scale and pilot scale laboratories in Shenzhen, where we have established R&D, GMP like manufacture, and quality management systems. This provided a solid technical and compliance assurance system for the development of various drugs.
We have also established an industrialization team. We have designed and constructed the world's first commercial plant for soluble MN TDDS in the Greater Bay Area of China, which is also the world's first sterile GMP plant for soluble MN TDDS. We have independently designed and developed a complete set of production equipment for this dosage form, with a batch capacity up to 100k pieces/batch. The factory is designed to meet all GMP regulatory requirements of China, US, and Europe, and supports drug research and commercial registration applications in all regulatory entities worldwide.
We have a complete set of proprietary intellectual property rights related to soluble MN TDDS technology, including prescriptions, processes, equipment, and quality standards. We also applied PCT for all of them.
We will continue our research in this field of MN TDDS technology, reform existing human drugs, and improve patients' quality of life while curing diseases.
1844, Irish surgeon Francis Rynd invented the world's first hollow needle, truly pioneering the history of modern injectable.
Today, the usage of oral drugs is ~62%, and the usage of injections is ~31%, together occupying ~93% of all human drugs, leaving all many other dosage forms only 7%.
In one word, they are the major methods we are using today.
1958, US Professor Alan Richard Wagner first proposed the concept of microneedle intradermal drug delivery technology. It is a revolutionary way to deliver drug candidates, via the maximum exposed surface area through the external skin route. It is painless and have minimal invasion of human organs because it will not reach anywhere deeper than human skin, so it should be a very compliant method to patients. An interesting fact is that lacking depth of needles does not mean less exposure this time while the ingredients passes through the lymphatic capillaries in the skin and eventually reach the circulatory system via human microcirculation system. Considering that all drugs are administered through the "skin" of some organs in human body (eg. gastric wall mucosa, intestinal mucosa, eye mucosa, other luminal mucosa, and surface skin), and the skin is the largest exposed organ which directly connecting the outside world, if we can achieve a painless and less invasive way through surface skin, this route should be very meaningful clinically, in order to reduce side effects (eg. gastrointestinal, first pass liver effects) and improve patient compliance.
Despite numerous scientists donated their investigations on microneedle transdermal drug delivery system (MN TDDS) since Professor Wagner, there are still a lot of CMC issues left in MN TDDS today to be challenged.
November 2020, 《Scientific American》 (an authoritative popular science magazine in US) selected 10 new technologies that are may change the world in 2020, and the MN TDDS is ranked as the 1st of all. This fully demonstrates that MN TDDS is extremely difficult, yet humans still have a strong desire and expectation to it, especially for the pharmaceutical industry.
BioQingLam is a high-tech enterprise specialized in soluble MN TDDS. We have a complete set of proprietary intellectual property rights related to MN TDDS, including but not limited to prescriptions, processes, equipment, and quality standards. We want to bring the change to the way of using drugs for all human being and have the potential to be the first one to achieve this goal with MN TDDS globally.
We have established a professional technical team in this niche field and successfully solved key CMC challenges such as drug loading, bioavailability, and content uniformity of MN TDDS.
We are oriented by delivery results and have tested our samples through animal models (such as rats, dogs, pigs, monkeys) and ultimately human studies, achieving drug delivery results that comply with regulatory requirements.
We have established small-scale and pilot scale laboratories in Shenzhen, where we have established R&D, GMP like manufacture, and quality management systems. This provided a solid technical and compliance assurance system for the development of various drugs.
We have also established an industrialization team. We have designed and constructed the world's first commercial plant for soluble MN TDDS in the Greater Bay Area of China, which is also the world's first sterile GMP plant for soluble MN TDDS. We have independently designed and developed a complete set of production equipment for this dosage form, with a batch capacity up to 100k pieces/batch. The factory is designed to meet all GMP regulatory requirements of China, US, and Europe, and supports drug research and commercial registration applications in all regulatory entities worldwide.
We have a complete set of proprietary intellectual property rights related to soluble MN TDDS technology, including prescriptions, processes, equipment, and quality standards. We also applied PCT for all of them.
We will continue our research in this field of MN TDDS technology, reform existing human drugs, and improve patients' quality of life while curing diseases.
BIOQINGLAM will be the leader in the field of microneedle drug delivery.
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2020Founded in 2020
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40+More than 40 patents for invention
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3000+Plant area of more than 3000 square meters
LEADERSHIP
LEADERSHIP
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Lin Jiang PhD.Founder/CEO/CSOMore
Dr. Jiang is the founder of BioQingLam and the chief scientist of the R&D and industrialization of dissolvable MN TDDS. He granted his organic chemistry PhD from the Chinese Academy of Sciences.
He has been continuously focusing on R&D and industrialization of this DDS for many years, granted over 40 invention patents.
Dr. Jiang is a serial entrepreneur. Since his doctoral graduation in 2006, he has gained 6 complete experiences in the entire chain from R&D to industrialization, company governance, and ultimately achieving enterprise product sales.
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Venus PoonR&D DirectorMore
Venus has more than ten years of experience in R&D, registration, and management of new drug formulations. She has served in multiple pharmaceuticals, responsible for the R&D, registration, and full lifecycle management for innovative drugs.
Venus is very familiar with the requirements of both research and registration for innovative drugs, especially the regulatory requirements of IND and NDA.
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Olivia ChenVP RA headMore
Olivia is an elite pharmacist. She is the 17th council member of GDPA, pharmaceutical engineering division, also a former CDE officer of China NMPA.
Olivia has almost 20 years’ experience for regulatory, supervision, and review. She served in several Chinese biotech and public companies as a senior regulatory role, leading more than 30 global regulatory campaigns while some of those are collaborated with Top 20 pharma such as Novartis and AstraZeneca.
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XingYou LiHead of Quality SystemXingYou is an experienced engineer with more than 15 years’ laboratory experience and worked in the quality department of pharmaceutical enterprises for more than 20 years. He is 3 times involved in the establishment inspection laboratory and also building up GMP system for 3 times. He is very familiar with ISO 9001、CNAS、WHO-PQ、EU GMP and FDA GMP, a truly veteran of GMP auditing profession.More
XingYou has been engaged in the fields of biological products, traditional Chinese medicine preparations, chemical drug preparations, etc. for many years. Experienced quality research works for various forms of medicines, including but not limited to sterilized freeze-dried powder vials, liquid ambers, tablets, capsules, soft capsules, suspensions. -
Tie ChenManufacture headTie Chen Director of factory Tie has over ten years of production management experience in big pharmaceuticals, specializing in the production process and technical management of sterile injections. He believes in the philosophy of lean production and performance management, and is proficient in quality, safety, and cost control. He has organized GMP certification for newly built workshops multiple times, and has also organized and participated in the re certification of EU GMP and the coordination of audits for Top 20 pharmaceutical companies.More
Lin Jiang PhD.
Venus Poon
Olivia Chen
XingYou Li
Tie Chen
SCIENTIFIC ADVISORY BOARD
SCIENTIFIC ADVISORY BOARD
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Bin WangScientific Advisory Board ProfessorExpert AdvisorsMore
Distinguished Professor and Doctoral Supervisor Fudan University
PhD of Biology University of Cincinnati
Postdoctoral Wistar Institute
Assistant Professor University of Pennsylvania
SCI paper 100+
US invention patent 10
PCT patent 30+
CN invention patent 8
Global 1st DNA vaccine trial for HIV, 1995
Editor of 《DNA&CellBiology》,《VirologicaSinica》,《Chinese Journal of Microbiology and Immunology》,《Acta Microbiologica Sinica》etc.
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XingYu JiangScientific Advisory Board ProfessorMore
Chair Professor, Doctoral Supervisor, Dean of the Department of Biomedical Engineering, Southern University of Science and Technology
PhD in Chemistry Harvard University
Served in National Center for Nanoscience and Technology, Chinese Academy of Sciences
Member of AIMBE, RSC
Outstanding Young Chemist of Federation of Asian Chemical Societies
SCI paper 400+
Invention patent 200+
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Hai Feng ZhangScientific Advisory Board ProfessorMore
PhD Professor, doctoral supervisor, and deputy director of the department of microelectronics science and technology at Harbin Institute of Technology;
Senior Member of IEEE
Organizing Committee Member of the Chinese Society for Micro and Nano Technology
Director of the Micro Nano Sensing Technology Branch of the National Society for Micro Nano Technology
Reviewer of JMC, MSSP, Water resource, Applied surface science, AIP advances, RSC advance, sensors review, Langmuir, Colloids and Surfaces A, Biosensors, SCIENCE CHINA,
Chinese Optics, Acta Electronica Sinica, etc.
SCI paper 100+ (3 with IF>10)
Invention patent 30+
Bin Wang Scientific Advisory Board Professor
XingYu Jiang Scientific Advisory Board Professor
Hai Feng Zhang Scientific Advisory Board Professor
CERTIFICATE OF HONOR
CERTIFICATE OF HONOR
MILESTONES
MILESTONES
Dec 2024：Construction of global 1st sterilized GMP MN plant finished, equipment deployment triggered, designed for 100,000 pieces/batch
Sept 2024：Human IIT of MN semaglutide read out
Oct 2023：Recognized as a national high-tech enterprise
CONTACT US
CONTACT US
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Factory address509, Building 1, No. 17, Cuishanhu Avenue, Cuishanhu New District, Kaiping City, Guangdong Province
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Tel.0755-21013290 19146466866 (Ms.Guo) -
Emailbioqinglam@bioqinglam.com
