Sterile Injectables
Sterile lyophilized powder injections · Sterile powder injections · Terminally sterilized small-volume injections
Pharmaceutical leadership · Manufacturing collaboration
Building Global
Pharmaceutical
Partnerships
Steven Li (李一青), President of Hainan Hailing Chemipharma, advances sterile injectable and lyophilized-product CMO/CDMO, technology transfer and international pharmaceutical cooperation.
- Established
- 2004
- 7 dosage-form platforms
- Public scope
- U.S. FDA inspected
- VAI · closed (2021)
For a non-confidential project discussion: stevenyiqingli@foxmail.comLinkedIn ↗
Review public evidence & source boundaries
An independent personal leadership and partnership website. It does not replace Hainan Hailing's official corporate or product information.
Partnership Pathways
Flexible routes from project evaluation to agreed manufacturing or technology collaboration.
01
CMO
Commercial manufacturing collaboration based on technical fit and agreed requirements.
02CDMO
Development and manufacturing support for suitable chemical-drug or small-molecule projects.
03Technology Transfer
Process, method and know-how transfer, including scale-up and validation support.
04Product & Registration Cooperation
Product, registration, licensing and market pathways subject to current project review.
05MAH Contract Manufacturing
For China-facing projects, support structured MAH-to-contracted-manufacturer assessment under applicable requirements, including NMPA Announcement No. 134 (2025), technology transfer, quality agreements and lifecycle oversight.
Hainan Hailing Chemipharma — Corporate Film
Hailing Pharma
Cares for Life
An archival corporate film with selectable Chinese and English captions, a complete transcript, chapter summaries and historical-content context.
Duration 05:59 · English voice-over · EN/ZH/TH/ID/VI/MS subtitles · Web publication 2026-07-19 View captions, chapters and full transcriptCurrent Public-Information Snapshot
Reviewed on 21 July 2026 from Hainan Hailing's official public pages, the FDA inspection record and the dosage-form scope confirmed for this website. Product-specific availability still requires project review.
- Company
- Founded in 2004 and publicly described as integrating pharmaceutical research and development, manufacturing and sales.
- Dosage forms
- Sterile lyophilized powder injections, sterile powder injections, terminally sterilized small-volume injections, tablets, capsules, creams and ointments.
- Product fields
- Dermatology, anti-infective, digestive-system, cardiovascular, diabetes and neurological medicines.
- R&D and cooperation
- The official website records that the R&D center was established in 2004 and that diversified technical and industry cooperation has been explored since 2007.
Public sources: company profileArchived 2026-05-18 · product fieldsArchived 2026-05-18 · R&D centerArchived 2026-03-09 · technical cooperationArchived 2026-05-18. Counts, registrations, available capacity and market eligibility are not inferred from these pages.
View reviewed Hainan Hailing facts and cooperation scope →Publicly confirmed dosage-form scope
Manufacturing &
Dosage-Form Platforms
Established platforms presented for initial project-fit and partnership discussions.
Oral Solids
Tablets · Capsules
Topical Dosage Forms
Creams · Ointments
Project-specific confirmation:
Product selection, registration status, available capacity, packaging, testing scope and market
eligibility are confirmed against current records during project review.
Request a Portfolio Review
Explore sterile injectable CMO/CDMO project fit →
Global Partnership Capability ProfileEnglish PDF · Version 1.0 · Published 19 July 2026
From Evaluation to
Commercial Manufacturing
A practical collaboration pathway, adapted to the product, market and regulatory requirements.
-
01
Project Evaluation
Objectives, product profile, development status, market and technical fit are reviewed.
-
02
Technology &
Method TransferProcess, analytical-method and critical know-how transfer is planned for the project.
-
03
Scale-up &
ValidationScale-up, confirmation and validation activities are defined according to project needs.
-
04
Regulatory &
Audit SupportTechnical documentation, registration readiness and customer-audit support are coordinated.
-
05
Commercial
ManufacturingManufacturing, packaging, testing and supply proceed under the agreed project scope.
Discuss Your Project
Begin with a focused review of your product, target market and collaboration goals.
Domestic and international business development
Global Cooperation,
Region by Region
Connecting Hainan with practical pharmaceutical opportunities through trusted local partners, project evaluation and long-term cooperation.
Explore Partnership View the ASEAN partnership pathway →
China
Southeast Asia
Middle East
Europe & North America
Latin America
Regional interest does not imply product approval, active registration or commercial availability in any listed market. Each pathway is assessed separately.
Evidence-aware public wording
Quality &
Regulatory Experience
U.S. FDA Inspection Experience
Hainan Hailing underwent an on-site U.S. FDA inspection in July 2021. In its October 2021 90-day decisional letter, the FDA classified the inspection as VAI and confirmed that the inspection was closed.
This statement describes an inspection outcome. It is not an FDA certification, approval or endorsement of the facility.
Continuous China GMP Compliance
Hainan Hailing operates under applicable Chinese pharmaceutical GMP requirements and is subject to ongoing regulatory oversight.
This website does not describe the facility as holding a current “China GMP certificate.”
Project decision architecture
Decision Resources for Pharmaceutical Partnerships
Move from public facts to a controlled project decision through three connected resources.
Quality & Regulatory Partnership
Responsibility matrix, quality communication and staged evidence.
Open resource →Project Evaluation Pathway
Non-confidential screen, NDA, diligence, transfer and readiness.
Open resource →Public Evidence Index
Dated third-party sources, regulatory references and verification boundaries.
Open resource →Global Partnership Workspace
Prepare a non-confidential brief, review the NDA path and begin a controlled project assessment.
Open workspace →
Pharmaceutical & healthcare internationalization
Steven Li
李一青
President, Hainan Hailing Chemipharma Corporation Limited
Educated in aerospace engineering at the University of Bristol, Steven Li previously worked as a process engineer at Commercial Aircraft Corporation of China, Ltd. (COMAC). His career spans aerospace manufacturing, industrial management and pharmaceuticals, with a current focus on CMO/CDMO, product and registration collaboration, and technology transfer.
Alongside his pharmaceutical leadership, Steven Li contributes to youth entrepreneurship, science and innovation, and social responsibility, bringing a cross-sector and execution-focused perspective to industry development and long-term partnership.
View Public ProfilePublic positions, social roles and recognitions are maintained from a reviewed public-profile record and are subject to periodic title and term verification.
Leadership
in Practice
A practical approach to internationalization: start with product and technical fit, align regulatory expectations, then build supply and trust over time.
Discuss a PartnershipPharmaceutical Partnership Guides
CMO/CDMO for Sterile Injectables
Start a non-confidential review by defining dosage form, presentation, target market, project stage, intended timing and whether the first discussion is CMO, CDMO or technology transfer. Public platform information is a starting point only; product fit, quality, regulatory, capacity and commercial scope remain subject to project-specific assessment.
Review the sterile injectable CMO/CDMO pathwayCMO for Lyophilized Products
Evaluate a prospective lyophilized-product partner through product-route fit, freeze-drying-cycle evidence, sterile-process controls and technology-transfer readiness. Public platform information is a screening input; suitability remains specific to the product, site, target market and controlled review.
Use the lyophilized-product CMO evaluation guideBuilding Sustainable Pharmaceutical Partnerships across Southeast Asia
Sustainable cooperation starts with a clear target market, a capable local partner, realistic registration planning and a supply model that can be maintained after launch.
Read full articleTechnology Transfer as a Path to Local Manufacturing
Technology transfer is a coordinated system of people, process, analytical methods, documentation, training, scale-up and validation—not a one-time document handover.
Read full articlePharmaceutical Contract Manufacturing Quality Agreements
A useful quality agreement turns outsourced-manufacturing roles into a practical responsibility matrix for qualification, release, deviations, change control, stability, recalls, audits and evidence retention.
Review the quality-agreement responsibilitiesEvaluating Sterile Injectable CMO/CDMO Projects
A disciplined assessment connects product, process, facility, analytical control, registration, quality governance and supply readiness before confidential transfer begins.
Read full articleCMO, CDMO or Technology Transfer?
Choose the cooperation model by product maturity, evidence gaps, regulatory responsibility and the intended operating end state.
Compare CMO vs CDMO and technology-transfer pathwaysHow to Audit a Pharmaceutical Contract Manufacturer
Use a risk-based CMO audit checklist to review site identity and scope, quality evidence, product fit, technology-transfer readiness and project governance before contracting.
Open the pharmaceutical CMO audit checklistFive Technology-Transfer Readiness Gaps to Resolve Before Scale-Up
Transfer readiness is not the number of files received. It is the receiving team’s ability to explain critical product knowledge, execute the process and methods, control materials and equipment, investigate variation and produce traceable evidence against agreed acceptance criteria.
Read full articleWhen Should a Pharmaceutical CMO/CDMO Project Be Placed on Hold?
A project should be placed on hold when a critical uncertainty cannot be converted into a controlled task with an owner, evidence, acceptance criteria and a realistic decision date. Holding is not failure; it protects product quality, regulatory integrity, capital and trust.
Read full articleView all insights and due-diligence guides →
Internationalization
Industry Development
Social Responsibility
Clear answers for prospective partners
Frequently Asked Questions
Who is Steven Li?
Steven Li, also known as Li Yiqing, is President of Hainan Hailing Chemipharma Corporation Limited. He focuses on pharmaceutical internationalization, manufacturing collaboration and responsible long-term development.
Which partnership models are discussed through this website?
CMO, CDMO, technology transfer, product and registration cooperation, and other project-specific pharmaceutical partnerships.
Which dosage-form platforms are publicly presented?
Sterile lyophilized powder injections, sterile powder injections, terminally sterilized small-volume injections, tablets, capsules, creams and ointments.
What is Hainan Hailing's U.S. FDA inspection status?
Hainan Hailing underwent an on-site U.S. FDA inspection in July 2021. The October 2021 90-day decisional letter classified the inspection as VAI and confirmed that it was closed. This is not an FDA certification or endorsement.
Does this website guarantee product availability or registration status?
No. Product availability, registration status, capacity, market eligibility and timelines are confirmed only through current project review and applicable official documentation.
Is there a universal minimum order quantity?
No. Minimum batch or order expectations depend on dosage form, process, packaging, target market, validation status and current production fit. A non-confidential assessment is needed before any project-specific range is discussed.
How is an indicative lead time established?
Lead time is built from feasibility, technology and method transfer, material readiness, validation, registration obligations, production scheduling and release. It should not be promised before the critical path is understood.
Can a prospective partner arrange a quality audit?
A staged due-diligence process can include document review, technical and quality meetings, and an on-site or remote audit after scope, confidentiality, participants and applicable requirements are agreed.
When should a project data room be opened?
After a mutual NDA and an agreed request list. Access should be role-based, time-limited and logged; the first website inquiry must not contain formulas, dossiers, patient information or trade secrets.
How are intellectual property and transferred know-how protected?
Ownership, permitted use, improvements, access, confidentiality, return or destruction, and post-termination support must be defined in written agreements before confidential transfer.
How is a quotation prepared?
A defensible quotation follows an agreed scope and assumptions for development work, analytical transfer, validation, materials, batch scale, packaging, regulatory support, supply and change responsibilities. An initial review may provide only an indicative scope.
Confidentiality starts with a focused first contact
Start a
Pharmaceutical
Partnership
Tell us your market, dosage form and cooperation objective. Your information will be submitted directly for an initial project-fit review.
Partnership email
stevenyiqingli@foxmail.com
Follow Steven Li on LinkedIn ↗Professional updates on pharmaceutical manufacturing, CMO/CDMO and technology transfer.
Prepare a project brief before submitting
Use the partnership workspace and editable Word/PDF templates to prepare a focused, non-confidential project summary.
Open project preparation workspace →