Toripalimab, Sintilimab and Other Newer PD-1 Medicines

They are anti-PD-1 monoclonal antibodies, the same class as pembrolizumab and nivolumab. Each blocks the PD-1 brake on T cells. Most were developed and first approved in China from 2018 onwards, and are now being registered in other countries, often through a licensing partnership with a local company.

People usually reach this page for one of two reasons. Either a drug name they have never heard of is written on a prescription, or someone has told them a cheaper immunotherapy exists. Both are reasonable starting points. The complication is that this is a group of medicines at very different stages, and general articles about “newer PD-1 inhibitors” tend to blur the ones you can actually get in India with the ones you cannot.

Grouping them on one page is deliberate. Individual Indian availability for several of these agents is either uncertain or actively changing, so a page per molecule would go stale faster than it could be maintained. What follows is the status as it stood in August 2026, molecule by molecule, with the uncertainty marked rather than smoothed over.

Three are approved and marketed in India: toripalimab since November 2024, tislelizumab since June 2025 and serplulimab since August 2025. Sintilimab is not approved. For camrelizumab, penpulimab and zimberelimab no Indian approval could be confirmed in August 2026. Each Indian approval covers one narrow indication.

Read the third column of the table below more carefully than the second. Approval is not general permission to use a drug in cancer; it is permission to use it in a named clinical situation. This is the single most common misunderstanding about this group of medicines, and it is the one that costs families money.

“Not confirmed” is not the same as “not approved”

The wording in that table is chosen carefully. Where a public regulatory record or a company announcement exists, this page says approved. Where the position could not be verified from a public source, it says not confirmed, and that is exactly what it means: unverified, in either direction.

This is a genuinely moving field. Approvals in this class have arrived in India several times a year recently, and CDSCO listings are the authoritative place to check rather than a pharmacy page or a news summary. New drug approvals are published by the CDSCO.

A caution specific to this group: several Indian approvals in this class have been granted with a Phase IV study condition attached, meaning the regulator wanted more data in Indian patients after marketing began. That is a normal and reassuring safeguard, not a warning sign, but it is worth knowing that the Indian experience with some of these molecules is still being collected.

The newer entrants are meaningfully cheaper per vial than the long-established PD-1 medicines, but the comparison is not straightforward: the vials are different sizes, the dosing conventions differ, and one is dosed by body weight. Compare the cost of a cycle, not the cost of a vial.

The figures below are published Indian pharmacy listings and company announcements, gathered so the arithmetic is visible. They are indicative, as of August 2026. None of them is a hospital rate, and no rate is quoted on this page against any of these molecules.

Three things that table cannot tell you, and that matter more than the numbers in it.

1. The vial price is a fraction of the bill. Day care, nursing, pre-cycle blood tests, response-assessment scans and any chemotherapy given alongside are billed separately. Response-assessment imaging is generally coordinated at partner imaging centres rather than performed in-house.
2. A weight-based drug behaves differently on cost. Serplulimab is dosed at 4.5 mg/kg, so the number of vials rises with body weight in a way it does not for a flat-dosed medicine. Two patients can be quoted very different figures for the same drug.
3. Listings move, and they disagree with each other. Retail MRPs, discounted online listings, hospital pharmacy rates and any manufacturer support arrangement can all differ on the same day, for the same vial.

Ask for a written, itemised estimate covering the whole planned course before the first cycle, and ask your insurer separately what it will and will not cover. High-cost immunotherapy is frequently capped or excluded, and a newer molecule is exactly the kind of thing a policy can decline for want of precedent.

Because these medicines are not interchangeable. Each Indian approval names a cancer, a stage and a line of treatment. A PD-1 antibody approved for nasopharyngeal carcinoma is not an alternative for lung cancer simply because it is the same class and costs less.

This is worth spelling out, because the logic that feels obvious to a family is the wrong logic here. If two drugs block the same receptor, why should one work and the other not? The answer is that approval is not a statement about the receptor. It is a statement about the trials that were actually run: in which cancer, at which stage, against which comparator, with which chemotherapy alongside. A molecule tested in nasopharyngeal carcinoma has evidence in nasopharyngeal carcinoma.

So the useful question to bring to a consultation is not “can we use the cheaper one?” It is the sequence below.

1. What exactly is my diagnosis, in the words on the biopsy report? Histology and site both matter. Squamous is not adenocarcinoma; small cell is not non-small-cell.
2. Which line of treatment am I in? First line, after chemotherapy, or after progression on something else. Approvals are line-specific.
3. Which PD-1 medicines are approved in India for that exact situation? That list is usually very short, and sometimes it has one entry or none.
4. Among those, is there a cost difference? This is the only point at which price becomes a legitimate part of the conversation.
5. If none is approved for my situation, what else is there? Including, honestly, the option of not using immunotherapy at all — which for most Indian patients is the realistic answer.

Most people who search a PD-1 drug name are not candidates for that drug. Saying so early is not pessimism. It saves months and, quite often, a great deal of money.

Each approved molecule rests on its own phase 3 programme, and those programmes were largely conducted in Chinese populations. Benefit is described in a proportion of patients in the populations studied. Indian-population data is thinner, which is why several approvals here carry a post-marketing study condition.

That is a limitation to state plainly rather than to hide. It is also the reason the CDSCO Subject Expert Committee, reviewing a sintilimab trial proposal in November 2025, noted that safety in the Indian population had not been adequately addressed by the available data and asked for a Phase I study here before a Phase III. Regulators applying that standard is the system working, not failing.

What it means for a patient is narrow and practical. The class effect — that blocking PD-1 helps some people and not others, and that no test predicts which with certainty — is well established and applies to all of these molecules. What is less established for the newer entrants is how they perform specifically in Indian patients over years. Anyone who speaks confidently about that is going beyond what is known.

No survival figures are quoted on this page. Company announcements about these medicines often lead with one, and a single number lifted out of a trial in another population is not a basis for a treatment decision. Ask your oncologist what the evidence says for your diagnosis, and ask what happens if the first response assessment shows no benefit.

Because Indian availability in this group is uneven and changing, claims about it circulate faster than they can be checked. Five steps settle almost any of them.

1. Ask which regulator approved it, and for what. A Chinese or European approval is not an Indian one. The question is what the CDSCO permitted, and in which indication.
2. Check the CDSCO new-drug listings rather than a pharmacy page. Online pharmacy descriptions are routinely copied from foreign labels and list cancers the Indian approval does not cover.
3. Ask the treating hospital’s pharmacy directly. Approved and stocked are different things. Narrow-indication biologicals are often ordered in rather than held, which adds days.
4. Insist on documentation for anything sourced outside the hospital. Batch number, importer, and an unbroken cold chain between 2 and 8 °C. Counterfeit checkpoint inhibitors have been reported entering the Indian supply chain, and a newer, less familiar brand name is exactly where that risk concentrates.
5. Get the quotation dated and itemised. Drug separated from day care, nursing, laboratory and imaging. An undated total is not a quotation.

If a supplier is reluctant to answer any of these in writing, that reluctance is the answer. A legitimate supply route produces this paperwork without difficulty.

Tislelizumab has enough Indian detail of its own to warrant a separate page: Tislelizumab: What It Is and Whether It Is Available in India covers its approval, its narrow Indian label and its published pricing.

Two of the differences in the cost table above come from how the dose is set rather than from the price of the vial. How Immunotherapy Doses Are Calculated: mg/kg vs Flat Dose explains why serplulimab behaves differently from tislelizumab on a bill, and Subcutaneous Injection vs IV Drip Versions of Immunotherapy covers the shorter-visit formulations and their Indian status.

For a checkpoint inhibitor with a very different profile — a PD-L1 antibody with a short, specific indication list — see Avelumab (Bavencio): Uses and Availability in India. For the wider view across the class, biosimilars and the other medicine groups, start from Immunotherapy Medicines Explained, or from the main immunotherapy section.