Haiyitan (Gumarontinib Hydrate)

Haiyitan (gumarontinib) is an oral, potent, and highly selective small-molecule inhibitor of the mesenchymal-epithelial transition factor (MET, also called c-MET). It is approved for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 (METex14) skipping mutation.

Gumarontinib works by blocking the activity of the MET receptor tyrosine kinase. In tumors carrying a METex14 skipping mutation, MET signaling becomes abnormally prolonged and drives cancer cell growth, survival, and spread. By selectively inhibiting MET, gumarontinib interrupts this oncogenic signaling, slowing or stopping tumor progression in patients with this specific molecular alteration.

METex14 skipping mutations occur in approximately 3 to 4% of NSCLC cases and represent an actionable driver mutation, often seen in older patients. Identifying these patients through molecular testing is important, since gumarontinib is intended specifically for METex14-positive disease.

It is a prescription medicine and must be used under the supervision of a qualified oncologist.

Recommended Dosage:
In clinical use, Haiyitan is taken as a 300 mg oral dose once daily (administered as the 50 mg tablets at the strength dispensed). In the pivotal trial, gumarontinib was given in continuous 21-day cycles and continued until there is evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
The treating physician determines the appropriate dosing, dose interruptions, and dose reductions based on the patient’s tolerability and the approved product information. Patients should follow their physician’s instructions on how and when to take the tablets and should not adjust the dose on their own.

• Edema, particularly peripheral edema (swelling of the hands, feet, or legs), is the most commonly reported side effect of gumarontinib and other MET inhibitors. Patients should promptly inform their physician about any new or worsening swelling, as treatment adjustments or supportive care may be required.
• Gumarontinib may cause low blood albumin levels (hypoalbuminemia) and changes in liver function tests, including increased bilirubin and elevated ALT or AST levels. Regular blood tests may be recommended by your physician to monitor these laboratory values during treatment.
• Some patients may experience additional side effects such as decreased appetite, headache, nausea, or vomiting while receiving gumarontinib. If any symptoms become persistent, severe, or concerning, patients should consult their treating physician for appropriate medical advice and management.
• Before starting gumarontinib, patients should inform their physician about all prescription medicines, over-the-counter products, vitamins, and herbal supplements they are taking. This helps the healthcare provider identify and manage any potential drug interactions during treatment.
• There is limited information on the use of gumarontinib during pregnancy or while breastfeeding. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits with their treating physician before starting treatment.

What documents are required to import HAIYITAN to India?

HAIYITAN (gumarontinib hydrate) may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a qualified doctor
• The patient’s diagnostic reports
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and an import permit, if applicable.

Is HAIYITAN available in India?

HAIYITAN (gumarontinib hydrate tablets) is a prescription medicine that legally requires a doctor’s prescription to be dispensed. As of current publicly available information, HAIYITAN is not commercially marketed in India.

However, patients in India can legally access HAIYITAN through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

Indian Pharma Network (IPN) acts as a facilitator under named patient supply, providing input on:

• Availability of HAIYITAN in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, etc.) and pathways to access it
• Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE).
  HAIYITAN price in India under the NPP route
• Sourcing from genuine, reliable channels in the USA, Canada, Europe, and Australia
• Ensuring full transparency throughout the process

HAIYITAN can be made available to patients, doctors, and hospitals in 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.

Indian Pharma Network (IPN) can source HAIYITAN from reliable channels across the world and facilitate supply to patients, doctors, and hospitals, offering worldwide access to this treatment under applicable legal provisions. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the patient’s address from New Delhi, India, after legal requirements are fulfilled.

For Haiyitan cost in India and availability, contact IPN at WhatsApp: +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@indianpharmanetwork.in.

Global Approval Status:

Haiyitan (gumarontinib) has been approved by regulatory authorities for the treatment of METex14 skipping mutation-positive NSCLC:

• China: The National Medical Products Administration (NMPA) granted conditional approval in March 2023 for locally advanced or metastatic NSCLC with MET exon 14 skipping mutations. Gumarontinib received Breakthrough Therapy Designation and was reviewed under the priority review procedure.
• Japan: Approved by the Ministry of Health, Labour and Welfare (MHLW) in June 2024 for unresectable, advanced, or recurrent METex14 skipping mutation-positive NSCLC. In Japan, it is supplied as Haiyitan Tablets 50 mg, with Haihe Biopharma K.K. and Taiho Pharmaceutical involved in its launch.

Approval was supported by the pivotal GLORY study (ClinicalTrials.gov NCT04270591), a single-arm, multicenter, open-label Phase 1b/2 trial conducted at 42 centers across China and Japan. In the Phase 2 stage, adults with locally advanced or metastatic METex14-positive NSCLC received gumarontinib 300 mg once daily. The trial reported an objective response rate of approximately 66% overall, with higher responses (about 70%) in treatment-naive patients and about 60% in previously treated patients, alongside durable responses. The most common treatment-related adverse events were edema and hypoalbuminemia, and the overall safety profile was considered manageable.

Gumarontinib was discovered and developed in-house by Haihe Biopharma. Outside China, rights for development, manufacturing, and commercialization in Japan, Asia (excluding China), and Oceania were licensed to Taiho Pharmaceutical in 2024.

Note: Approval and marketing status vary by country. As of current publicly available information, Haiyitan is not approved or commercially marketed in India.

What is the generic name for the brand drug Haiyitan?

Gumarontinib is the generic (international nonproprietary) name for the brand drug Haiyitan.

What is Haiyitan used for?

Haiyitan (gumarontinib) is used for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries a MET exon 14 (METex14) skipping mutation.

Who develops and manufactures Haiyitan?

Haiyitan was discovered and developed by Haihe Biopharma, co-developed with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. Taiho Pharmaceutical (an Otsuka Holdings subsidiary) holds the license for Japan, Asia (excluding China), and Oceania.

What type of medicine is gumarontinib?

Gumarontinib is an oral, potent, and highly selective small-molecule MET (c-MET) tyrosine kinase inhibitor — a targeted therapy for tumors driven by MET exon 14 skipping mutations.

Is Haiyitan approved by the FDA?

As of current publicly available information, Haiyitan is not approved in the United States. It is approved in China and Japan.

Where is Haiyitan approved?

Haiyitan is approved in China (conditional approval, March 2023) and Japan (June 2024) for METex14 skipping mutation-positive NSCLC.

What strength and dosage form is available?

Haiyitan is available as 50 mg oral tablets. The clinical dose is 300 mg once daily, taken under the supervision of a qualified physician.

What are the most common side effects of Haiyitan?

The most commonly reported side effects are edema (especially peripheral edema), nausea, vomiting, hypoalbuminemia, decreased appetite, headache, and laboratory abnormalities such as increased blood bilirubin and elevated liver enzymes (ALT/AST).

How does Haiyitan import in India work?

Haiyitan import in India is possible through the Named Patient Program (NPP) — on behalf of an individual patient with a valid doctor’s prescription. Indian Pharma Network (IPN) helps manage the process, including documentation, approvals, and delivery, so the medicine reaches the patient safely and legally.

Who is a reliable Haiyitan supplier in India?

Indian Pharma Network (IPN) facilitates compliant access to Haiyitan in India through global sourcing channels and structured documentation support for eligible patients, in accordance with applicable regulatory provisions.

How much does Haiyitan cost in India?

Haiyitan is not yet approved or marketed in India, but patients can legally access it through the Named Patient Program. Prices may vary over time due to market and regulatory factors. For the latest Haiyitan cost in India, call +91 96548 60915 or WhatsApp +91 98104 69557 or email info@indianpharmanetwork.in.

Can Haiyitan be accessed in SAARC countries?

Yes. In addition to Gulf countries, Haiyitan can be accessed through import provisions such as the Named Patient Program in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). IPN can help facilitate compliant supply where permitted by local regulations.

Is it safe to buy Haiyitan tablets online in India?

Yes, one can buy Haiyitan in India through the Indian Pharma Network (IPN), as this product is not yet registered or available in the country. IPN can help facilitate the import of Haiyitan tablets through legal channels.

Can Haiyitan be delivered to my treating hospital?

Yes. IPN can facilitate delivery of Haiyitan to the patient’s treating hospital across major Indian cities, under the Named Patient Program, with a valid doctor’s prescription and import permit where applicable. Leading hospitals include AIIMS Delhi, Sir Ganga Ram Hospital, Medanta – The Medicity, Apollo Hospitals Chennai, Christian Medical College (CMC), PGIMER, Kidwai Memorial Institute of Oncology, Adyar Cancer Institute, Amrita Hospital, Artemis Hospital, Safdarjung Hospital, Kauvery Hospital, Sri Ramachandra Medical Centre, Cytecare Cancer Hospital, MIOT International, SCTIMST, NIMS Hospital, KIMS Hospitals, AIG Hospitals, Bombay Hospital, Lilavati Hospital, Care Hospitals, Narayana Health City, Jaslok Hospital, Yashoda Hospitals, Fortis Memorial Research Institute, Kokilaben Dhirubhai Ambani Hospital, P. D. Hinduja Hospital, Manipal Hospitals, Aster Medcity, Indraprastha Apollo Hospital, King George’s Medical University (KGMU), Shalby Hospitals, Tata Memorial Centre, HCG Cancer Center, Basavatarakam Indo-American Cancer Hospital, Cancer Institute (WIA), Max Healthcare, and Rajiv Gandhi Cancer Institute & Research Centre.

What are the storage conditions for Haiyitan tablets?

Haiyitan tablets should be stored at room temperature, kept in the original packaging, and protected from moisture, unless the dispensed product information specifies otherwise. Always follow the storage instructions on the product label and keep out of the reach of children.

Disclaimer: Haiyitan (gumarontinib hydrate tablets) is a prescription medicine and should only be used under the supervision of a qualified healthcare professional. Product availability, import requirements, and access pathways vary by country-specific regulations. Treatment is intended for patients whose tumors carry a confirmed MET exon 14 skipping mutation, as determined by appropriate molecular testing. This page is for informational purposes and does not constitute medical advice.