Hainan Poly Pharm

What Hainan Poly Pharm does

Hainan Poly Pharm Co., Ltd. (Shenzhen Stock Exchange: 300630) is a Chinese pharmaceutical company founded in 1992 and headquartered in Haikou, Hainan Province. The company operates an integrated pharmaceutical platform spanning active pharmaceutical ingredients (APIs), sterile injectables, oral solids, dry suspensions, pre-filled syringes, eye drops, ointments, and oral liquids, manufactured across three cGMP-compliant production bases in Haikou, Hangzhou (via Zhejiang Poly Pharmaceutical Co., Ltd.), and Anqing (via Anhui Poly Pharmaceutical Co., Ltd.). Its technology portfolio includes API-plus-formulation integration enabling synchronized Chinese and international regulatory filings, controlled-release and modified-release formulations, pediatric dry suspension with taste-masking and weight-based precision dosing, a synthetic biology pipeline (Ectoin, Salidroside, NMN, Ursodeoxycholic Acid), and a differentiated BNCT boron drug platform covering BPA, BSH, carbon-boron intermediates, and injection-type boron[10B]falmet freeze-dried powder meeting dual 99% purity standards. The company holds 275+ international dosage form approvals including 43 US ANDA approvals and distributes products in 40+ countries across the Americas, Europe, Southeast Asia, Africa, the Middle East, Central Asia, and Oceania.

The company generates revenue through five primary streams: (1) finished dosage form export sales of US FDA and EU EMA approved injectables, controlled-release tablets, dry suspensions, and contrast agents; (2) CDMO/CMO contract manufacturing services offering CMC R&D, BE studies, cGMP production guidance, and international market entry support; (3) API direct sales via Anhui Poly with US DMF, EU CEP, and China CDE registrations; (4) MAH license and registration transformation services; and (5) domestic Chinese OTC and prescription drug sales through standard pharmaceutical wholesale channels. Pricing is not publicly disclosed; international transactions are negotiated through direct enterprise sales engagements. Customer segments include global pharmaceutical distributors, API enterprises seeking API-plus-formulation partnerships, formulation companies pursuing overseas market entry through joint ventures and co-registration, innovative R&D institutions (notably BNCT collaborators), and Chinese domestic OTC consumers.

The company maintains strategic BNCT partnerships with the Chinese Academy of Sciences Institute of High Energy Physics, the China Spallation Neutron Source Science Center, Guoke Zhongzi Medical Technology (for drug-device combination), and Dongguan People's Hospital (clinical trial site). Poly Pharm is recognized in multiple industry rankings including the 2022 China Top 100 Chemical Pharmaceutical Enterprises, 2024 and 2025 China Chemical Drug R&D Strength Top 100, and 2023 Hainan Top 100 Enterprises.

Name

Hainan Poly Pharm

Legal name

海南普利制药股份有限公司

Website

https://hnpoly.com

Company type

Public

Founded year

1992

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Hainan Poly Pharm is a Chinese pharmaceutical manufacturer (SZSE:300630) producing generic injectables, APIs, contrast agents, dry suspensions, and BNCT boron drugs across three cGMP bases, distributing in 40+ countries with 275+ international approvals and 43 US ANDAs.

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210), Medicinal and Botanical Manufacturing (325411)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

Keywords

• Generic pharmaceuticals
• Active pharmaceutical ingredients
• Injectable formulations
• Contrast media manufacturing
• CDMO contract manufacturing

Headquarters

HQ city

Haikou

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Finished Dosage Form Export Sales (制剂出口销售): Revenue from selling US FDA-approved and EU EMA-approved finished dosage forms (injectables, controlled-release tablets, dry suspensions, contrast agents) to global markets across 40+ countries. Key products include iodixanol injection securing hundred-million-yuan orders from US and Argentina markets.
2. CDMO/CMO Contract Manufacturing Services (CDMO/CMO服务): Providing contract development and manufacturing organization services for domestic and international pharmaceutical companies. Services include CMC R&D for injectable consistency evaluation, complex injectable safety assessment, BE studies, cGMP manufacturing guidance, and international market expansion support.
3. API (Active Pharmaceutical Ingredient) Sales (原料药销售): Sale of proprietary and co-manufactured active pharmaceutical ingredients including contrast agents, anti-tumor APIs, and BNCT boron drugs. Anhui Poly serves as the API platform with global registrations (US DMF, EU CEP, China CDE).
4. MAH License and Registration Services (MAH持证转化服务): One-stop MAH holder transformation services supporting product commercialization post-approval with dual-report (China + international) advantages. Offers integrated API-formulation capability with non-restricted R&D and commercialization.
5. OTC and Domestic Prescription Drug Sales (国内处方药/OTC销售): Domestic Chinese market sales of NMPA-approved prescription and OTC products including Adapalene Gel, Desloratadine products, and pediatric formulations sold through domestic pharmaceutical distribution channels.

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

Hainan Poly Pharm manufactures and distributes generic pharmaceutical products and APIs across formulations (injectables, dry suspensions, controlled-release capsules, contrast agents, OTC products) and active pharmaceutical ingredients. The company sells to international pharmaceutical distributors, API enterprises, and formulation companies in 40+ countries, and provides one-stop CDMO/CMO services covering CMC R&D, cGMP manufacturing, and international registration support. It also develops innovative oncology products including BNCT boron drugs and operates a synthetic biology platform for cosmetic and functional food ingredients.

Product overview

Hainan Poly Pharm is a pharmaceutical company offering a comprehensive portfolio of prescription drugs, OTC products, active pharmaceutical ingredients (APIs), and contract manufacturing services. The company operates across multiple product categories including injectable products (such as Azithromycin, Voriconazole, and Ganciclovir), dry suspension formulations for pediatric use, contrast agents (Iopamidol, Gadobutrol), and innovative BNCT (Boron Neutron Capture Therapy) boron drugs. The company provides CDMO/CMO services leveraging its cGMP-compliant manufacturing facilities in Haikou, Hangzhou, and Anqing. Product portfolio covers therapeutic areas including anti-infectives, oncology, contrast imaging, cardiovascular drugs, and neurological medications, with regulatory approvals spanning the US, EU, Australia, and over 40 countries globally.

Differentiator

Problem solved

Functional benefit

Brands

• 芙必叮: 地氯雷他定分散片、地氯雷他定糖浆等皮肤科用药品牌
• 闪释
• 积雪苷霜软膏

Products and services

• Injectable Pharmaceutical Products (注射剂) Sterile injectable finished dosage form products including Azithromycin for Injection, Voriconazole for Injection, Ganciclovir for Injection, Tigecycline for Injection (50mg), Dobutamine Hydrochloride Injection (250mg/20ml, 500mg/40ml), and Cyclophosphamide for Injection. Manufactured under US FDA and EU EMA cGMP standards for global distribution.
• Pediatric Dry Suspension Products (干混悬剂) Pediatric-friendly dry suspension formulations including Azithromycin, Voriconazole, Fluconazole, Linezolid, Oseltamivir, Desloratadine, and Trimebutine dry suspensions. Features precision weight-based dosing with taste-masking technology for accurate pediatric dosing and improved medication compliance.
• Contrast Agent Products (造影剂) Radiological contrast media products covering gadoteric acid, gadoteridol, gadolinium butoxide, iopamidol, iopromide, ioversol, iodixanol APIs and formulations for imaging diagnostics with integrated manufacturing capability from API to finished dosage form.
• Active Pharmaceutical Ingredients (API) (原料药) Active pharmaceutical ingredient manufacturing including contrast agents (Gadoteric acid meglumine, Gadobutrol, Iopamidol), anti-tumor APIs (Cyclophosphamide), BNCT boron drug APIs, magnesium hydroxide, and various pharmaceutical excipients with global registrations (US DMF, EU CEP, China CDE).
• BNCT Boron Drug Products (硼中子俘获治疗硼药) Boron Neutron Capture Therapy products including BPA raw material, BSH raw material, carbon boron module intermediates, and Injection Boron[10B]Farlen freeze-dried powder for injection. Product achieves dual 99% standard: boron-10 isotope abundance ≥99% and pharmaceutical chemical purity ≥99%. Targeted at treatment of recurrent head and neck malignancies, glioma, kidney cancer, and cervical cancer.
• CDMO/CMO Services (CDMO/CMO合同研发与生产服务) Contract development and manufacturing organization services including CMC R&D for injectable consistency evaluation, complex injectable safety assessment, BE studies, cGMP manufacturing guidance, and international market expansion support. Covers APIs, injectables, biologics, and traditional Chinese medicine from R&D through registration and commercialization with dual-report (China + international) filing capability.
• Adapalene Gel (OTC) (阿达帕林凝胶) Over-the-counter topical retinoid gel for mild-to-moderate acne vulgaris treatment addressing comedones, papules, and pustules on the face, chest, and back. Suitable for long-term maintenance therapy. Achieved 360 million RMB in sales across China's three major terminals six markets in 2025, growing 2.15% YoY.
• Topiramate Extended-Release Capsules (托吡酯缓释胶囊) Extended-release capsule formulation enabling 24-hour steady drug release with once-daily dosing. Long-acting controlled-release core technology with in vitro/in vivo dissolution consistency and pharmacokinetic profile matching standards. Indicated for epilepsy, bipolar disorder, and migraine prevention. Global market size $800 million in 2025 with US being 47% market share.
• Synthetic Biology Products (合成生物学产品) Biosynthetic products including cosmetic ingredients (Ectoin, Salidroside), functional food and nutraceutical ingredients (NMN, Ursodeoxycholic Acid), enzyme-catalyzed APIs and intermediates, and probiotic-based health products (probiotic sleep-aid chewable tablets). Developed through enzyme catalysis and microbial fermentation.

Quantifiable outcome

• 275 international dosage form marketing approvals including 43 US ANDA approvals; products sold in 40+ countries
• +6 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core.

• 国科中子医疗科技有限公司 (Guoke Zhongzi Medical Technology Co., Ltd.)coreStrategic or Co-development Partner · 1 July 2025Joint development partner for BNCT (Boron Neutron Capture Therapy) drug-device combination products. Poly Pharm provides injection用硼[10B]法仑 (boron[10B]falmet) while Guoke Zhongzi provides the BNCT treatment system (RFQ-BNCT equipment). Both parties are co-conducting Phase I clinical trials at Dongguan People's Hospital and preparing combined product regulatory filings in both China (NMPA) and the United States.
• 中国科学院高能物理研究所 (Chinese Academy of Sciences Institute of High Energy Physics)coreStrategic or Co-development Partner · 1 July 2025Strategic collaboration for BNCT technology development. The Institute provides neutron source technology foundation from the China Spallation Neutron Source (CSNS) national scientific infrastructure. Poly Pharm develops boron drugs for BNCT therapy using the neutron beam. This is a core government-academia partnership for China's BNCT advancement.
• 散裂中子源科学中心 (China Spallation Neutron Source Science Center)coreStrategic or Co-development Partner · 1 July 2025Collaborative partner providing access to the China Spallation Neutron Source (CSNS) facility for BNCT research and development. The Center supports neutron beam research essential for BNCT boron drug testing and clinical application, underpinning Poly Pharm's BNCT drug development program.
• 南方医科大学第十附属医院（东莞市人民医院）(Southern Medical University Tenth Affiliated Hospital / Dongguan People's Hospital)coreStrategic or Co-development Partner · 1 July 2025Clinical trial site for BNCT Phase I clinical study treating recurrent head and neck malignancies. The hospital serves as the primary clinical research center, providing patient enrollment, treatment administration, and clinical outcome assessment for Poly Pharm's injection用硼[10B]法仑 combined with BNCT equipment.
• 中科高能所 / 中国科学院高能物理研究所 (China Institute of High Energy Physics)coreStrategic or Co-development Partner · 1 July 2025Collaboration on multiple BNCT boron drug projects for treating glioma, kidney cancer, and cervical cancer. The partnership leverages the Institute's neutron physics expertise and Poly Pharm's pharmaceutical development and manufacturing capabilities to advance next-generation boron drug development.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Lupin Limited: India-based generic manufacturer with strong US ANDA portfolio and growing injectable/specialty capabilities. Comparable on the US FDA-regulated generic injectable strategy, and a direct peer for emerging-market generics expansion.

Broad incumbents

• CSPC Pharmaceutical Group: Major Hong Kong-listed Chinese pharmaceutical manufacturer with strong generic and innovative drug pipeline. Comparable on Chinese-to-international generic strategy and injectable manufacturing capabilities.
• WuXi AppTec: China-based global CRO/CDMO leader with deep small-molecule API and biologics capabilities. Comparable on CDMO service model and global regulatory expertise, though at vastly larger scale and with broader modality coverage.
• Teva Pharmaceutical Industries: Global leader in generic pharmaceuticals with extensive US and EU generic footprint. Comparable on the global generics strategy Poly Pharm is scaling, though operates at vastly larger scale across many more molecules and geographies.
• Sandoz (Novartis): Global generic and biosimilar leader with extensive US FDA and EU EMA dossier library. Comparable as a benchmark on international generic injectable and oral solid execution; not a direct Chinese-market competitor.
• Shanghai Fosun Pharmaceutical: Large diversified Chinese pharmaceutical group with API, formulation, CDMO (via子公司), and international distribution. Overlaps with Poly Pharm on generic injectables, contrast agents, and international regulatory filings, but operates at much larger scale and broader portfolio.
• Yangtze River Pharmaceutical Group: One of China's largest privately held pharmaceutical manufacturers, with broad generic and OTC portfolio and growing international presence. Comparable on finished dosage form manufacturing and pediatric formulation capabilities, but with domestic-centric focus.

Direct peers

• Zhejiang Huahai Pharmaceutical: China-based manufacturer of APIs and finished dosage forms with deep US FDA and EU EMA registration footprint, particularly in cardiovascular and CNS generics. Highly comparable on API+formulation integration, international regulatory strategy, and Chinese generics export model.
• Asymchem Laboratories (Tianjin Asymchem): Chinese CDMO offering small-molecule API development and manufacturing with significant US/EU exposure. Comparable on integrated API CDMO services and cross-border regulatory capabilities for pharmaceutical partners.

Regional players

• Hikma Pharmaceuticals: Jordan-based generic injectables and oral manufacturer with strong Middle East/North Africa distribution. Highly comparable on the geographic playbook Poly Pharm pursues in emerging markets and on injectable generic approvals in regulated markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Hainan Poly Pharm