Hainan Shuangcheng Pharmaceuticals

What Hainan Shuangcheng Pharmaceuticals does

Hainan Shuangcheng Pharmaceuticals Co., Ltd. (海南双成药业股份有限公司) is a Chinese specialty pharmaceutical company founded in 2000 and listed on the Shenzhen Stock Exchange (002693) since August 2012, headquartered in Haikou with a major manufacturing subsidiary in Ningbo. The company specializes in chemically synthesized peptide drugs and small-molecule generic injectables and oral solids, with four commercialized peptides (Thymalfasin/Jitai, Somatostatin, Thymopentin, Bivalirudin) and an additional 13 peptides in pipeline including Semaglutide, Tirzepatide, Goserelin, Linaclotide, and Lanreotide.

Manufacturing is vertically integrated across two cGMP-compliant sites (Chinese GMP, EU GMP, US GMP) spanning roughly 2.7 million sq ft, covering peptide APIs (200-300 kg/yr), lyophilized vials, sterile injections, oncology products, and high-volume oral solid doses. The company has accumulated multiple US FDA ANDA approvals (Bivalirudin, Pregabalin, Memantine, Paclitaxel Albumin-bound, Bortezomib), passed repeated FDA/EMA/AIFA/TGA inspections, and successfully challenged the Bivalirudin RLD patent to enter the US market ten years ahead of patent expiry.

Revenue is generated through three streams: domestic proprietary drug-product sales to hospitals and pharmacies via a network of regional agents (covering 23 small-molecule products in 36 strengths plus peptide drugs), export of APIs and finished dosage forms to regulated markets (US, EU, Australia, Middle East, South Asia with Thymalfasin registered in 30+ countries), and contract development and manufacturing (CDMO/CMO) services supplying peptide intermediates and sterile injectable manufacturing to international pharmaceutical clients. The company operates a wholly-owned subsidiary in Italy to support international operations and has been actively licensing out products based on 2026 disclosures.

Name

Hainan Shuangcheng Pharmaceuticals

Legal name

Hainan Shuangcheng Pharmaceuticals Co., Ltd.

Website

https://shuangchengmed.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

251–500 employees

Short description

Hainan Shuangcheng Pharmaceuticals is a China-based, Shenzhen-listed specialty pharmaceutical manufacturer of chemically synthesized peptide drugs and small-molecule generics, serving domestic hospitals and international CDMO/regulated-market customers from cGMP-compliant facilities in Haikou and Ningbo.

Ownership category

akta.pro rank

Product category

Peptide Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical and Medicine Manufacturing (32541)

SIC

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

akta.pro primary industry

Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

akta.pro secondary industries

Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Compounding Ingredient & API Distributors (Pharma Supply) (HLAIAJAO), Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

Keywords

• Peptide drug manufacturing
• Pharmaceutical CDMO services
• Active pharmaceutical ingredients
• Sterile injectable formulations
• Generic pharmaceuticals

Headquarters

HQ city

Haikou

HQ country

China

HQ region

Asia

Offices3 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. Proprietary Drug Product Sales: Sales of domestically approved drug products including peptide drugs (Thymosin Alpha 1 for Injection, Bivalirudin for Injection, Eptifibatide Injection, Octreotide Acetate Injection) and small-molecule drugs (Bortezomib, Pregabalin, Famotidine, etc.) across hospitals, pharmacies and distributors in China
2. API Manufacturing and Sales: Manufacturing and sale of peptide active pharmaceutical ingredients including Thymalfasin, Somatostatin, Bivalirudin, Eptifibatide, and others to domestic and international pharmaceutical clients; multiple DMF/CEP registrations filed
3. CDMO/CMO Services: Contract development and manufacturing organization services for international pharmaceutical companies; provides services in peptide synthesis, sterile injectables manufacturing, and product registration support for international markets
4. International Product Registration and Export: ANDA filings and export of approved drug products to regulated markets (US, EU, Australia); products exported to US include Bivalirudin for Injection, Paclitaxel (Albumin-bound), Memantine Hydrochloride Tablets

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Hainan Shuangcheng Pharmaceuticals develops, manufactures, and markets chemically synthesized peptide drugs (Thymalfasin/Jitai, Somatostatin, Thymopentin, Bivalirudin) and small-molecule generic drugs (Bortezomib, Pregabalin, Eptifibatide, Octreotide, Paclitaxel Albumin-bound, among others), alongside peptide APIs and CDMO/CMO services for international pharmaceutical clients. The company operates two main manufacturing bases (Haikou and Ningbo) that are CGMP-compliant and have passed US FDA, EU EMA, Italian AIFA, and Australian TGA inspections. Products are distributed across China through regional agents and exported to more than 30 countries including the U.S., EU, Australia, Saudi Arabia, and Pakistan.

Product overview

Hainan Shuangcheng Pharmaceuticals is a high-tech pharmaceutical company specializing in chemically synthesized peptide drugs. The company operates as a vertically integrated pharmaceutical manufacturer offering both drug products and APIs. The product portfolio centers on four core chemically synthesized peptide drugs: Thymalfasin for Injection (基泰/Jitai), Somatostatin for Injection, Thymopentin for Injection, and Bivalirudin for Injection. Beyond peptides, the company has expanded into small molecule drugs including Bortezomib, Pregabalin, Eptifibatide, Octreotide, Paclitaxel (Albumin-bound), Semaglutide, Tirzepatide, and others across 23 drug products in 36 strengths. The company also provides peptide APIs with 13 peptides in various development stages and four peptide intermediates for export. CDMO services support international pharmaceutical partnerships. The company is listed on Shenzhen Stock Exchange (002693) and operates from facilities in Haikou, Hainan and Ningbo, Zhejiang.

Differentiator

Problem solved

Functional benefit

Brands

• Jitai (基泰): Brand name for Thymalfasin for Injection (注射用胸腺法新), an immune enhancement drug for chronic hepatitis B, tumors, and infections
• Chao Tai (超泰)
• Danting (旦汀)
• Zhengli (珍泰)
• Ganmeiduolan (甘美多兰)
• Shuangcheng Bowen (双成博维)
• Shuangcheng Kewei (双成可维)
• Zhuoli (卓力)
• Liangtai (良泰)
• HNSP

Products and services

• Thymalfasin for Injection (注射用胸腺法新 / Jitai 基泰) Peptide immunomodulator indicated for chronic hepatitis B treatment, immune enhancement in immunocompromised patients, and as a vaccine response enhancer. Synthesized via solid-phase synthesis with 99% purity; marketed under the Jitai (基泰) brand in China and exported globally.
• Bivalirudin for Injection (注射用比伐芦定) Direct thrombin inhibitor anticoagulant for injection used in percutaneous coronary intervention (PCI) and PTCA. Reversibly inhibits thrombin to prevent clotting during cardiac procedures. Marketed in China, exported to the U.S., and approved in Australia.
• Bortezomib for Injection (注射用硼替佐米) Proteasome inhibitor for treating multiple myeloma and mantle cell lymphoma. Administered via 3-5 second IV push or subcutaneous injection at 2.5mg/mL concentration.
• Octreotide Acetate Injection (醋酸奥曲肽注射液) Synthetic octapeptide mimicking somatostatin for controlling symptoms of acromegaly, gastroenteropancreatic neuroendocrine tumors, and prevention of pancreatic surgery complications. Marketed in China under the Zhengli (珍泰) brand.
• Pregabalin Capsule (普瑞巴林胶囊) GABA derivative with analgesic and anticonvulsant properties indicated for postherpetic neuralgia, fibromyalgia, diabetic peripheral neuropathy, and epilepsy adjunct therapy. Available in 75mg strength.
• Somatostatin for Injection (注射用生长抑素) Synthetic cyclic 14-amino acid peptide inhibiting growth hormone, thyroid-stimulating hormone, insulin, and glucagon secretion. Used for acute esophageal variceal bleeding and pancreatic surgery complications. Marketed in China under the Chaotai (超泰) brand.
• Clindamycin Hydrochloride for Injection (注射用盐酸克林霉素) Lincosamide antibiotic injectable. Marketed in China under the Zhuoli (卓力) brand.
• Ligustrazine Phosphate for Injection (注射用磷酸川芎嗪) Small-molecule cardiovascular injectable marketed in China under the Liangtai (良泰) brand.
• Famotidine for Injection (注射用法莫替丁) H2-receptor antagonist injectable for acid-related gastrointestinal conditions. Marketed in China under the Shuangcheng Kewei (双成科维) brand.
• Levocarnitine for Injection (注射用左卡尼汀) Amino-acid derivative injectable marketed in China under the Shuangcheng Bowen (双成博维) brand.
• Pantoprazole Sodium for Injection (注射用泮托拉唑钠) Proton pump inhibitor injectable for acid-related gastrointestinal conditions.
• Sodium Ferulate for Injection (注射用阿魏酸钠) Cardiovascular injectable marketed in China.
• Paclitaxel (Albumin-bound) for Injection Microtubule inhibitor indicated for treating metastatic breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. A high-difficulty complex pharmaceutical preparation requiring strict GMP standards, manufactured at the Ningbo subsidiary for the U.S. market.
• Semaglutide (GLP-1 peptide, marketed by another brand) GLP-1 receptor agonist peptide in the company pipeline; available in multiple strengths (2.4mg/0.75ml, 4mg/3ml, 8mg/3ml) for diabetes management. Noted as one of 13 peptides at various stages of development.
• Tirzepatide (dual GIP/GLP-1 peptide) Dual GIP and GLP-1 receptor agonist in the company pipeline, available in multiple dosage strengths (2.5mg to 15mg per 0.5ml) for diabetes treatment. Noted as one of 13 peptides at various stages of development.
• Eptifibatide Injection GP IIb/IIIa receptor antagonist injectable for preventing clotting during PCI and treating unstable angina pectoris or non-Q-wave myocardial infarction. Available in 20mg/10mL and 75mg/100mL strengths and approved by the Australian TGA.
• Vasopressin Injection Pituitary hormone injection available in 20 units/mL strength for indicated therapeutic uses. Noted as approved by the Australian TGA in August 2025.
• Goserelin Implant GnRH agonist implant available in 3.6mg and 10.8mg strengths for hormone-sensitive conditions (prostate cancer, breast cancer, endometriosis).
• Linaclotide Capsule Guanylate cyclase-C agonist peptide available in 72mg, 145mg, and 290mg strengths for irritable bowel syndrome with constipation and chronic idiopathic constipation.
• Lanreotide long-acting injection Somatostatin analog depot injection available in 60mg/0.2mL, 90mg/0.3mL, and 120mg/0.5mL strengths for acromegaly and neuroendocrine tumors.
• Peptide APIs (Active Pharmaceutical Ingredients) Active pharmaceutical ingredients including 13 peptides at various stages of development and four peptide intermediates exported to U.S. clients. Includes Thymalfasin, Somatostatin, Bivalirudin, Eptifibatide, Bortezomib, Octreotide Acetate APIs among others, with multiple DMF/CEP registrations filed.
• CDMO/CMO Services Contract Development and Manufacturing Organization services providing peptide API synthesis, sterile injectable manufacturing, and product registration support to international pharmaceutical partners. The company has supplied peptide intermediates to U.S. clients and provides end-to-end support for international product registration in U.S., EU, and other regulated markets.

Quantifiable outcome

• Successfully challenged the patent of RLD of Bivalirudin for Injection and received US FDA final approval, entering the US market 10 years before patent expiry
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Ningbo Shuangcheng Pharmaceuticals Ltd (宁波双成药业有限公司)coreStrategic or Co-development Partner · 1 January 2014Established as a holding subsidiary in Ningbo, Zhejiang Province, NBSP operates as a major manufacturing base with approximately 2.13 million sq. ft. of manufacturing space. It has received US FDA approval for its facilities and manufactures oncology injectables and oral solid dosage forms. The subsidiary successfully passed US FDA inspection in October 2019 and manufactures key export products including Paclitaxel (Albumin-bound) for the U.S. market.
• Hainan Weile Pharmaceuticals Co., LtdminorStrategic or Co-development Partner · 1 January 2010Acquired by Hainan Shuangcheng Pharmaceuticals in 2010, Hainan Weile Pharmaceuticals became a subsidiary expanding the company's product portfolio and manufacturing capabilities in Hainan Province, China.

Scale indicators10 records

Recent moves8 records

Expansion highlights6 records

Regional players

• Hutchmed: Hong Kong-listed Chinese pharma with FDA-approved oncology drug and U.S. commercial operations. Similar Chinese origin and FDA pathway strategy, though focused on innovative oncology rather than generic peptides.
• 3SBio: Chinese biopharmaceutical company with peptide, biosimilar, and generic injectable portfolio. Operates in the same domestic China regulatory and hospital channel environment as Shuangcheng.
• Zai Lab: China-based biopharma with strong FDA engagement and approved products in U.S. market. Comparable international regulatory track record and Anatomic to Shuangcheng's U.S. ANDA approvals via its FDA filings.

Direct peers

• PolyPeptide Group: Swiss-listed peptide CDMO offering custom peptide synthesis, APIs, and finished injectable manufacturing to pharma clients globally. Directly comparable to Shuangcheng's CDMO and peptide API offering.
• Hybio Pharmaceutical: China-based specialty peptide API manufacturer focused on chemically synthesized peptides for pharmaceutical use, directly overlapping with Shuangcheng's peptide API and finished dosage product strategy. Both serve domestic and international CDMO clients.

Emerging players

• CordenPharma: Specialized CDMO with peptide and injectable manufacturing capabilities serving global pharma clients. Comparable in offering peptide intermediates and sterile fill-finish like Shuangcheng, though operates at different scale.

Broad incumbents

• Sun Pharmaceutical Industries: India's largest generic pharmaceutical company with broad finished injectable and oral solid portfolio including FDA-approved products. Operates comparable finished dosage ANDA strategy to Shuangcheng at much greater scale.
• Dr. Reddy's Laboratories: Indian generic pharmaceutical major with extensive FDA-approved sterile injectable portfolio including bivalirudin and other cardiovascular injectables. Comparable in finished injectable generic strategy targeting regulated markets.
• Bachem: Swiss-listed leading global peptide CDMO with manufacturing for peptide APIs and oligonucleotides across therapeutic categories. Larger-scale, established player compared to Shuangcheng in the same peptide chemistry domain.
• Ipsen: European specialty pharma with deep peptide franchise (Somatostatin analogs such as Somatuline, Decapeptyl/Trelstar). Overlaps with Shuangcheng's Somatostatin and Bivalirudin injectable offerings, though at innovator specialty scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/hainan-shuangcheng-pharmaceuticals-co-ltd-

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries3 records

Funding overview

Funding rounds2 records

Investors2 records

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 Shuangcheng Pharmaceuticals