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Inpegsomatropin

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Inpegsomatropin

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Inpegsomatropin
Generic Name (API): Inpegsomatropin (Y-shape pegylated recombinant human growth hormone)
Dosage Form & Strength: 2.5 mg, 3.0 mg, 3.5 mg, 5.0 mg; 2.0 mg vial
Route: Subcutaneous injection
Drug Class: Long-acting pegylated recombinant human growth hormone

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Inpegsomatropin Used For?

Inpegsomatropin is a once-a-week growth hormone injection for children who are not growing properly because their body makes too little growth hormone. It was developed and is made in China by Xiamen Amoytop Biotech, where it is sold as 益佩生® (Yipeisheng). Instead of the daily injections many children need, it is given just once a week.

China's National Medical Products Administration (NMPA) approved it in May 2025 for:

  • Slow growth caused by growth hormone deficiency (GHD)
  • In children aged 3 years and older

It is a prescription hormone medicine and should only be used under a paediatric endocrinologist.

How It Works

Growth hormone is made by the pituitary gland at the base of the brain and drives the growth of bones and muscles, mostly through a second messenger called IGF-1. Inpegsomatropin is lab-made human growth hormone with a large, Y-shaped (branched) 40 kD polyethylene glycol (PEG) chain attached to it. This "PEG coat" slows down how fast the body clears the hormone, so one injection keeps working for a whole week. The company says it is the first Y-shaped PEG growth hormone approved anywhere.

What the Trial Showed

The phase 3 trial, published in The Journal of Clinical Endocrinology & Metabolism, included 391 children aged about 3 to 11 years at 23 centres in China. Two in three received weekly inpegsomatropin, and one in three received standard daily growth hormone injections, for 52 weeks. Children on the weekly injection grew an average of 9.91 cm in the year, compared with 10.04 cm on daily injections (before treatment they were growing about 3.5 cm a year). This showed the weekly medicine works as well as daily treatment, using a lower total weekly dose and with 52 injections a year instead of about 365.

Recommended Dosage

  • Usual dose: 0.14 mg per kg of body weight, once a week, ideally on the same day each week
  • The doctor may adjust the dose every 3 to 6 months depending on how well the child is growing
  • Missed dose: give it as soon as possible within 3 days; if more than 3 days have passed, skip it and give the next dose on the usual day
  • Injected under the skin of the tummy, the middle of the outer thigh or the upper arm; avoid the same spot within 30 days and keep injections at least 2 cm apart

As an example, a 20 kg child would need about 2.8 mg a week. It comes as a ready-to-use clear liquid in prefilled cartridges of 2.5 mg, 3.0 mg, 3.5 mg and 5.0 mg, or a 2.0 mg vial. Your doctor sets the exact dose.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Who should not use it: children allergic to inpegsomatropin or any ingredient, children whose growth plates have already closed, anyone with an active or growing tumour, and people who are critically ill after open-heart or abdominal surgery, multiple injuries or sudden breathing failure.

  • Allergic reactions: serious allergy is rare. The label advises that the first dose be given at a hospital or clinic, with one hour of observation, especially for children with a history of allergies.
  • Thyroid and adrenal glands: growth hormone can unmask an underactive thyroid or lower cortisol levels. Thyroid tests are checked during treatment, and children on steroid replacement may need their dose adjusted.
  • Blood sugar: growth hormone can make the body less sensitive to insulin, so blood sugar is monitored, particularly in children at risk of diabetes.
  • Headache or vision changes: rarely, raised pressure inside the head can occur, usually in the first 8 weeks. Severe or repeated headaches, blurred vision, nausea or vomiting need an urgent check.
  • Hip or knee pain and the spine: a limp or hip/knee pain should be checked for a slipped hip growth plate, and the spine is checked regularly for scoliosis while growth is fast.
  • Injection site: rotating sites helps avoid lumps or thinning of the fat under the skin.

Side effects in the trial: no very common (10% or more) side effects linked to the medicine were reported. The most frequent were injection site reactions (9.6%), raised liver enzymes ALT and AST (1.1% each), joint pain (1.1%), raised TSH (0.8%), rash (0.8%) and eyelid swelling (0.8%). Serious events were similar with weekly and daily treatment (6.5% vs 6.2%), only 1.5% stopped in each group, and no child on inpegsomatropin developed new antibodies against it.

How to Access Inpegsomatropin in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Inpegsomatropin to India?

The injection can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified paediatric endocrinologist
  • Reports confirming growth hormone deficiency, such as growth hormone stimulation tests, IGF-1 levels, a bone age X-ray and the child's growth chart
  • Patient ID proof (issued by the Government of India) and the parent or guardian's details

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Inpegsomatropin available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. Your child's endocrinologist may also want to read about Ngenla, another once-weekly growth hormone that we import on prescription.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. The cartridges and vials must be kept at 2°C to 8°C, away from light, and must not be frozen or shaken hard, so they travel under temperature-controlled shipping from the source to your door or clinic. Because the dose is based on weight and changes as the child grows, we plan each order around the current prescription. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Families across India can access this medicine through regulated import pathways, with cold-chain delivery arranged to the home or treating hospital on a valid specialist's prescription.

Delhi

Paediatric endocrine clinics in Delhi see children from across North India, and our New Delhi dispatch point keeps the cold-chain journey short.

Mumbai

Parents in Mumbai can have the refrigerated cartridges delivered to their home or to the child's clinic.

Bangalore

Paediatric endocrinologists in Bangalore can request the medicine for a named child, with a written quote shared first.

Chennai

Doctors in Chennai can send us the growth chart and test reports to begin the import.

Hyderabad

We plan deliveries so a fresh supply arrives before the last weekly dose is used.

Kolkata

Shipments to Kolkata and the eastern states are packed to stay between 2°C and 8°C all the way.

Pune

Families in Pune can use the same documented import route, with updates at every stage.

Ahmedabad

The treating doctor can share the prescription and bone age report with us to start the import.

Chandigarh

Serves families from Punjab, Haryana and Himachal Pradesh, with delivery to the home or treating hospital.

Jaipur

Families across Rajasthan can receive the medicine without travelling, as long as the import is in the child's name.

Lucknow

We coordinate cold-chain delivery to families and children's hospitals across Uttar Pradesh.

Kochi

Families in Kochi and nearby Kerala cities can have each supply delivered in insulated packaging.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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