TQH2722 files for approval: 12 days late, and two years late

As of September 18, 2026, two anti-IL-4Rα monoclonal antibodies have been approved in China, and marketing applications for several domestic peers are under review. But this queue cannot simply be ordered by initial acceptance date — withdrawals and refilings have already occurred in 2026.

The two approved: dupilumab (Sanofi and Regeneron) launched in China in 2020, and on February 27 this year won two new indications on the same day, adult bullous pemphigoid and maintenance treatment of asthma in children aged 6 and above, covering a cumulative 9 indications and population extensions (including age extensions, not 9 separate indications), with atopic dermatitis extended down to infants aged 6 months; stapokibart (Keymed Biosciences, brand name Kangyueda) launched in September 2024 as the first domestic product and has so far won three indications — moderate-to-severe atopic dermatitis in adults, chronic rhinosinusitis with nasal polyps and moderate-to-severe seasonal allergic rhinitis in adults — all three included in the 2025 edition of the NRDL, effective January 1, 2026, with the prefilled autoinjector pen listed at the same time.

Among domestic applications still currently valid and under review, TQH2722 is the most recently accepted. Its exact position should be determined by the current valid application status at CDE, not by each company's earliest acceptance announcement.

So the accurate statement is: TQH2722 is the most recent domestic anti-IL-4Rα monoclonal antibody to file and have accepted a marketing application for adult atopic dermatitis, not a fixed "nth place". Counting by "ever filed historically" and by "currently valid under review" gives different numbers, and mixing the two bases produces non-reproducible rankings. To avoid misjudgment, a disconfirming search was run here — the antibody approved on July 29 this year targets IL-36R rather than IL-4Rα and is not counted.

One more detail worth remembering: the proposed indication wording for TQH2722, SSGJ-611 and SHR-1819 is word-for-word identical, and the same as stapokibart's approved indication. This means that after launch, the label itself provides no tool for differentiation.

TQH2722 is a monoclonal antibody targeting IL-4Rα; by specifically binding IL-4Rα it inhibits both IL-4 and IL-13 signaling, blocking the type 2 inflammatory pathway upstream. A framing conflict needs flagging first: the company's September 2026 announcement calls it a "fully human" antibody, while the company's earlier announcement (2023), the ClinicalTrials.gov registration, Biosion's public materials and a 2025 peer-reviewed paper all call it "humanized". Until the company clarifies, this article makes no definitive judgment on its degree of humanization. It is not a bispecific, not a conjugate and involves no delivery platform; it is simply a conventional subcutaneous monoclonal antibody.

The target layer has been fully digested by predecessors: the global originator has been on the market since 2017, and two products are approved in China. This means target-level biological risk has been validated by others — but also that the mechanism itself provides no advantage. Note that target validation does not mean the candidate antibody is risk-free; dose, immunogenicity, safety and efficacy still depend on its own data.

The real problem is that no other advantage can be found in the public evidence.

Not on dosing frequency. The Phase 3 registration states "14 days per treatment cycle", i.e. dosing every two weeks in the study, the same as dupilumab and stapokibart (the final approved dose and regimen have not been published and cannot be treated as a settled marketed regimen). The Phase 1 first-in-human study was published in the Journal of Pharmaceutical Sciences: after a single subcutaneous dose, time to peak was 3 to 7 days, half-life 2.65 to 17.43 days, and after four repeated doses peak concentration and exposure accumulated about 3-fold, with nonlinear, greater-than-dose-proportional increases in exposure. This range from single doses in healthy volunteers alone is not enough to support a claim of a longer dosing interval; but equally it cannot rule out a higher dose or switching maintenance to every four weeks, which would need to be judged together with exposure–response, trough concentration and patient efficacy data.

And the "long-acting" card has already been taken by others: Mabgeek's MG-K10 is positioned on every-four-weeks dosing with about 13 injections a year; Sunshine Guojian's SSGJ-611 directly gave 52-week maintenance data for both every-two-weeks and every-four-weeks arms in its announcement.

Not on control design either. The Phase 3 was placebo-controlled with no active comparator. Submitting placebo-controlled data in a market where the originator has been on sale for six years and a domestic peer is already on the NRDL can prove efficacy, but cannot prove superiority.

It must be stated clearly that response rates cannot be compared directly across trials. But precisely because they cannot be compared, in the absence of head-to-head studies a latecomer has even less ability to use data to persuade prescribers to switch.

Registration is the tidiest box in the whole case. An independent 500-patient Chinese Phase 3, together with a Phase 1 in healthy volunteers and multiple Phase 2 studies — atopic dermatitis 160 patients (II-01), chronic rhinosinusitis 160 and 119 patients (II-02, II-04), seasonal allergic rhinitis 169 patients (II-05), plus seasonal allergic rhinitis II-06 started March 2026 with 300 planned patients, and the atopic dermatitis long-term safety and efficacy extension study II-03 (CTR20260098) — with co-primary endpoints using the internationally standard Week 16 dual endpoints, strict eligibility criteria and secondary endpoint follow-up to Week 60 including anti-drug antibodies and steady-state trough concentrations. This is the data package structure of a routine full approval, apparently needing no bridging and not looking headed for conditional approval — whether supplementary information is ultimately needed depends on CDE's review conclusion.

Execution is likewise a real strength: first patient enrolled in Phase 3 on October 8, 2024, primary completion on September 11, 2025, 500 patients enrolled and followed to the Week 16 primary endpoint within about 11 months, at 73 centers (counted line by line from the registry's raw site fields; media put it at 74). This speed is fast for atopic dermatitis in China (no uniform competitor benchmark was set; this is a qualitative judgment).

What needs restraint is not reading "tidy" as "safe". To date there has been no notice of Breakthrough Therapy Designation or priority review, which supports saying the launch date should not be built on an assumption of expedited review; the acceptance number itself is public — CXSS2600149, received by CDE on September 11, 2026, announced by the company on September 16; but CMC data and on-site inspection status are still not visible, so saying regulatory uncertainty is very low is premature. For comparison, stapokibart entered review with Breakthrough Therapy Designation for atopic dermatitis and priority review for two indications.

There is no room on price either. Stapokibart's application materials published by the National Healthcare Security Administration state that its price after patient assistance is lower than the reference drug dupilumab (the complete wording of the specific "buy two, get one free" scheme was not verified in that main document and should be sourced separately when cited). The price anchor has already been pressed below the originator by the first mover, and later entrants will find it hard to push up — this is a market judgment, not something that has already happened.

The asset logic of a company like Chia Tai Tianqing is precisely that the molecule may not be the strongest, but the commercial platform can turn a middling molecule into decent revenue. The question is whether that lever can be applied directly in dermatology.

The direct answer: it cannot be applied directly, but the company has more reason than its peers to build one.

Sino Biopharmaceutical's four core therapeutic areas are oncology, liver disease and cardiometabolic, respiratory and autoimmune, and surgery and analgesia. Biologic prescribing for moderate-to-severe atopic dermatitis is concentrated in tertiary hospital dermatology departments, and judging by the four publicly disclosed therapeutic areas, this department is not among the group's existing positions (the group has not disclosed department-level sales coverage data; this is an inference by therapeutic area). In respiratory, this year it just obtained commercialization rights in mainland China for GSK's Trelegy and Anoro, and in the first half revenue from key approved respiratory and autoimmune products was about RMB 1.36 billion, about 7.0% of total revenue — but that is respiratory medicine, not dermatology.

In other words, this is closer to "opening up a new department" than "adding another product to an existing position".

This also determines how the accounts for this product should be done: not as single-product input–output, but as "infrastructure investment in type 2 inflammation and dermatology", amortized jointly by TQH3906 and later indications. Correspondingly, the revenue model should be built on "low price, high penetration, stacked indications", not on an innovative drug premium.

One more box is only half filled: the registered strength(s) for the proposed launch have not been publicly disclosed, but the delivery device is not untraceable — clinical trial registration CTR20254860 explicitly covers a PK comparison of "TQH2722 injection (pen)" with a reference formulation, showing the pen has at least entered clinical bridging development. The real unknown is whether it can land together with the first marketing application. For comparison, stapokibart's prefilled autoinjector pen has already entered the NRDL along with its three indications. In a scenario of long-term self-injection every two weeks, a device arriving one step late is a prescribing disadvantage.

Manufacturing is not a bottleneck. A conventional monoclonal antibody, with no conjugate linker ownership issues, no nucleic acid delivery system and none of the supply chain complexity of cell therapy; the group has had a cumulative 20 national Class 1 or 2 innovative drugs and 8 biosimilars approved, so monoclonal antibody manufacturing and quality systems are in place. It should be noted that this product's specific manufacturing site, capacity and inspection records have not been disclosed; the above judgment is inferred from company scale and modality.

There are only two CMC actions really worth investing in: bringing unit cost down, and upgrading the delivery device. The former is the most solid long-term moat in a race likely to end in price competition; the latter is one of the few engineering means left to quickly create differentiation in a homogeneous race.

On ownership, however, there is an unknown that must be spelled out.

TQH2722 corresponds to Biosion's project number BSI-045A. The company's September 16 announcement describes it as "independently developed" by Chia Tai Tianqing, while Biosion's public statements describe it as "co-developed" with Chia Tai Tianqing. A verifiable clue comes from an exhibit to Aclaris Therapeutics' 2024 annual report: a collaboration agreement signed on November 18, 2024 among Chia Tai Tianqing, Biosion and Aclaris, which repeatedly cross-references a separate "IL-4R Agreement" and contains covenants not to sue Chia Tai Tianqing regarding the development, manufacture and commercialization of IL-4R monoclonal antibodies.

The main transaction assets in that tripartite agreement are two others (BSI-045B and BSI-502), and the words BSI-045A or TQH2722 do not appear anywhere in it; but its Article 2 explicitly brings "IL4R Monoclonal Antibodies" within scope, so one cannot simply say the agreement has nothing to do with this product. The real problem is that the parties, territory and economic terms of the cross-referenced "IL-4R Agreement" itself are entirely undisclosed.

So there is only one correct way to put it: beneath this product lies a layer of contractual relationships that has never been made public. One can neither say overseas rights are fully retained nor that they have been licensed out. Until this relationship is disclosed, any plan to go global is empty.

Finally, two numbers nobody mentions but that are there as soon as you look.

The group has a total of 10 national Class 1 innovative candidates in respiratory and autoimmune at clinical stage or beyond, 6 of which are in Phase 3. TQH2722 has to compete for the same budget, sites and management attention with TQC3721 (an inhaled PDE3/4 inhibitor already licensed to AstraZeneca: US$200 million upfront + up to US$1.9 billion in additional milestones + tiered royalties, nominal potential total US$2.1 billion), TDI01 (a ROCK2 inhibitor, Phase 3 in idiopathic pulmonary fibrosis), TQH3906 (a TYK2 inhibitor, Phase 3 in psoriasis) and TQC2731 (a TSLP antibody, Phase 3). And in the company's external narrative, all of these rank ahead of it.

More subtly, there are two direct relationships within the portfolio.

One is overlap. One of TQC2731's Phase 3 indications is exactly chronic rhinosinusitis with nasal polyps, while TQH2722 has already run two Phase 2 studies in this direction (160 and 119 patients), yet as of the registry cutoff no Phase 3 registration has been seen. There may be a connection between these two facts, but the company has made no public statement, so this can only be written as an inference, not a conclusion.

The other is substitution. TQH5528 is an oral STAT6 degrader, and STAT6 is precisely the node where IL-4 and IL-13 signaling converge downstream — what an oral degrader aims to replace mechanistically is the injectable IL-4Rα monoclonal antibody. To be clear, globally there is not yet Phase 3 evidence that an oral STAT6 degrader can replicate biologic-level efficacy, so this is a reasonable mechanism-level inference, not an established fact.

Put these two together with the company's low external disclosure intensity on this product, and the direction is consistent: TQH2722 looks more like the first entry ticket to this race than the endgame molecule the company is betting on. It must be qualified that this judgment rests on indirect evidence such as pipeline structure and disclosure intensity; the company has made no public statement, so it is an inference, not a conclusion.

In the first half of this year Sino Biopharmaceutical had revenue of RMB 19.44 billion, innovative drug and out-licensing revenue of RMB 8.79 billion (45.2% of the total), and R&D investment of RMB 3.29 billion (16.9% of revenue), with a cumulative 20 Class 1 or 2 innovative drugs approved and nearly 30 more expected over the next five years. This is a company that lacks neither money, nor pipeline, nor execution.

So TQH2722's problem was never "can it be made". Enrolling 500 patients in Phase 3 in 11 months, at 73 sites, meeting both primary endpoints, complete 52-week data — all of this has been achieved.

The problem is that it stands in a back position — exactly which place has to be determined by current valid application status at CDE — its label is word-for-word identical to the two ahead of it, its dosing frequency is the same as the two marketed peers, the more convenient "every four weeks" direction has already been claimed in narrative by two others (to be clear: SSGJ-611 has published 52-week maintenance data for an every-four-weeks arm, which is not the same as having a label for that regimen), the price anchor has been pressed below the originator by the first domestic peer, NRDL coverage timing is still up in the air, and within its own company's pipeline a next-generation oral molecule is already being developed.

For such an asset, the right expectation is not "how much can it sell", but "how much does it cost to use it to open the dermatology door".

Whether this entry ticket is worth it depends on who stands behind the door. Based on current public information, the one standing there is TQH3906.