Laikangqitamab (LZM012): a strong hand as "China's first dual-target", played into China's most cutthroat autoimmune race

Laikangqitamab (R&D codes XKH004 / LZM012) is a humanized IgG1 antibody targeting both IL-17A and IL-17F. What is special about it is that, through clever design of the antibody epitope, a single antibody can bind both homodimers, IL-17A-A and IL-17F-F, as well as the IL-17A-F heterodimer — shutting down the most critical "messengers" on this inflammatory pathway at once. This mechanism is exactly the same as that of the world's only marketed drug in the class, UCB's bimekizumab (Bimzelx).

The molecule originated at Xinkanghe Biotech. This company, set up in 2015 in Zhongguancun Life Science Park, draws its scientific character from immunologist Academician Dong Chen — whose research on the IL-17/Th17 pathway is world-class, and who revealed the role of IL-17F in inflammation in a leading journal as early as 2008. In other words, this molecule is not a "me-too" drawn up to follow a trend, but one that grew out of first principles of the pathway's mechanism.

But a biotech focused on early research can hardly push a molecule to market alone. In 2017, Xinkanghe licensed the project to Zhuhai Livzon Mab — the antibody arm of Livzon Pharmaceutical Group (listed in both A and H shares, with parent Joincare). From then on a classic relay structure formed: source innovation left to the scientists; clinical advancement, manufacturing and commercialization left to a veteran pharma company with money, capacity and a sales force. This combination has determined almost every subsequent strategic choice for the molecule.

In this structure there is an often-overlooked but far-reaching detail: who the value actually belongs to. From public records, after the 2017 license, rights to carry out development, registration, manufacturing, sales and even sublicensing (i.e. passing overseas rights to third parties) fell mainly on Livzon's side; Xinkanghe, as the molecule's source, shares in returns mainly through milestones and revenue sharing, with the specific split not disclosed. This means: the one really holding the steering wheel of this molecule's commercial fate is Livzon, the listed company, not the research-oriented biotech. For Xinkanghe, the molecule is long since not something it "sells itself" but something it "splits the money on"; for Livzon, it is a core asset that can be folded into its own commercial map, with Livzon deciding when and where to monetize it. Understanding this ownership is what makes all subsequent judgments on pricing, NRDL and the pace of going abroad stand up — because the decision-maker is a player that isn't short of money and can afford to wait.

In China, psoriasis affects about 7 million people, about 5 million of whom have moderate-to-severe disease requiring systemic therapy. This is a genuinely big disease, and as biologic penetration climbs, the market is still expanding. Laikangqitamab placed its lead indication here.

Its most persuasive card is its willingness to go head-to-head. In its psoriasis Phase 3, it didn't take the easy "vs placebo" route, but directly challenged the mainstay IL-17A inhibitor in China's first line — secukinumab (Novartis's Cosentyx):

Psoriasis Phase 3 head-to-head: laikangqitamab 320 mg vs secukinumab 300 mg (every 4 weeks)

The weight of these numbers is that it is currently the only domestic IL-17 drug to have beaten secukinumab head-to-head, meeting both non-inferiority and superiority criteria at once. Faster onset, deeper clearance and long-term maintenance — it takes all three. "Completely clear" and "staying clear", which dermatologists value most, are precisely its strengths. The lead site was the dermatology department of Huashan Hospital, Fudan University — endorsement from a top domestic center, so clinical acceptance is not a concern.

The second indication, ankylosing spondylitis (AS), also delivered. In a 323-patient Phase 3 in moderate-to-severe active disease (laikangqitamab 160 mg every 4 weeks), the ASAS40 response rate at Week 16 was 45.5%, far above placebo's 19.4% (P<0.001), with ASAS20 of 62.2% vs 34.8%, and consistent performance in patients with and without prior TNF inhibitors. The Phase 3 trials for both indications met all their primary endpoints.

Why does "dual-target" deserve a second look? The inflammatory core of psoriasis is the IL-17 pathway, and in the IL-17 family, IL-17A has been the recognized protagonist for the past decade, while IL-17F has long been treated as a supporting player. Research in recent years has shown ever more clearly that in skin lesions, IL-17F is actually expressed at much higher levels than IL-17A, just with weaker activity per molecule; blocking only IL-17A leaves an inflammatory channel "slipping through the net". Neutralizing A and F together can in theory shut down downstream inflammation more thoroughly — exactly the story the dual-target mechanism wants to tell, and the biological basis for beating single-target secukinumab head-to-head. Clinically, PASI 100 represents complete clearance where "not a single lesion can be seen on the skin", the watershed for patient satisfaction and quality of life; and maintaining complete clearance in more than 70% at Week 52 shows it is not "fine while on it, back once you stop", but holds steady. Together, these two points form its hardest reputational asset in physicians' minds.

Because of this report card, the psoriasis marketing application was accepted on December 24, 2025 and granted priority review as early as January 7, 2026, on the grounds that it met the criteria for a breakthrough therapy. Faster review means that, if all goes well, approval could come as early as H1 2027.

Switch the perspective from "is the molecule well made" to "is this a good business", and the tone of the story changes. Laikangqitamab is often introduced as "China's first and the world's second" IL-17A/F dual-target antibody to complete Phase 3. Every word of that is true, but "world's second" is a ranking of progress, not of efficacy; and the qualifier "domestic" in front of "first" is precisely the crux.

More subtle is another detail: laikangqitamab's head-to-head opponent has always been secukinumab, a first-generation single-target IL-17A drug, and it has never gone head-on with bimekizumab — the real same-mechanism global benchmark. Beating "the previous generation" does not mean catching up with "the same generation". When overseas buyers or payers do due diligence, they will immediately ask: "What about versus Bimzelx?" — and that is precisely a gap the current data cannot answer directly.

At the other end of the race, domestic single-target IL-17A has long since become a red ocean: Genrix Bio's xeligekimab (psoriasis approved August 2024, AS approved early 2025, on the NRDL, with its self-set price at one point pushed down to RMB 798/vial) and Hengrui's vunakizumab (Andajing, approved for psoriasis and AS in succession in 2024); on the import side there are also secukinumab and ixekizumab (Lilly's Taltz), both on the market for years and long on the NRDL. From day one of launch, a new molecule faces a row of peers already on the NRDL with prices anchored at RMB 700–800.

Moreover, the threat doesn't only come from within IL-17. In psoriasis, what really exerts generational pressure on IL-17 is another class of mechanism — IL-23 inhibitors. IL-23 drugs such as guselkumab (J&J's Tremfya) and risankizumab (AbbVie's Skyrizi), with lower dosing frequency (as infrequent as one injection every 12 weeks) and equally excellent skin clearance, are capturing the long-term maintenance market in psoriasis. For patients focused only on skin lesions, IL-23 drugs that need "just a few injections a year" are increasingly attractive. This means that even if laikangqitamab wins within IL-17, it still faces a flanking fight for share from IL-23.

Pushing this molecule from today to scaled sales requires clearing several hurdles. Interestingly, for it, most of the industry's generic "high-risk hurdles" have already been leveled, and the real difficulties are concentrated in the last mile.

✓ Hurdles already cleared (positive factors)

• Registration execution risk — essentially zero. Clinical approvals, enrollment and primary endpoints for both indications are all done, and the marketing application has been accepted and granted priority review. The most uncertain question, "will the clinic succeed", is already in the past for it.
• Manufacturing and supply — self-controlled. Livzon Mab has mature large-scale antibody capacity in Jinwan, Zhuhai, has repeatedly passed EU GMP, FDA and PIC/S inspections, and uses digital twins to support process scale-up. With no reliance on external contract manufacturing and both registration and commercial batches in its own hands, this is an underrated hard strength among domestic peers.
• Money and time — no suspense. The licensee is a consistently profitable listed company (Livzon's 2025 net profit attributable to shareholders is on the order of RMB 2.2 billion), so this project has no cash cliff of the "burn through the money and die" kind that single-asset biotechs face. It can negotiate slowly and need not sell cheap.

✗ The truly hard hurdles (high-risk factors)

• NRDL and price war — the line between life and death. Domestic peers have already pressed prices down into the RMB 700–800 range of NRDL Category B. For laikangqitamab to scale, it can hardly avoid national NRDL negotiation, and whether the clinical value of "dual-target superior to single-target" can win a decent price at the negotiating table is the core variable for commercial success or failure.
• The "real value" of differentiation — squeezed by both first movers and patents. The imported originator with the same mechanism has already been approved for the same indications, and domestic peers are already on the NRDL. Laikangqitamab's differentiation narrative must be sharp enough, or payers will easily treat it as "just another IL-17" when bargaining.
• The overseas road — still very hazy. In all public materials, there is no trace of any FDA or EMA communication or multi-regional trial. The existing data are purely Chinese domestic studies, and whether US and European regulators will accept them is doubtful. Overseas monetization can only come through out-licensing, and the gap of "no head-to-head with Bimzelx" will be asked about again and again in buyers' due diligence.

Despite the thorns above, viewed within a "China-first" frame, its logic is actually quite coherent.

First, the demand is real and huge. 7 million with psoriasis, 5 million moderate-to-severe, plus AS with a patient pool in the millions — this is not a niche market propped up by epidemiological narrative, but a genuinely big disease. China's psoriasis guidelines have long set "PASI 100 complete clearance" as the treatment goal and recommend moderate-to-severe patients start biologics early. Laikangqitamab's "faster, cleaner, lasting" data hit exactly what guidelines and physicians prefer.

Second, it doesn't need to "educate the market", only to "grab penetration". The IL-17 pathway has already been validated and taught in China by the likes of secukinumab, and physicians and patients are familiar with it. Laikangqitamab doesn't need to tell the story from scratch; what it has to do is use "dual-target + head-to-head superiority" to cut into single-target drugs' share in a mature category — far less effort than opening up an entirely new mechanism.

Third, the Livzon shell happens to fill its gaps. Whether a molecule sells well in China often depends more on channels and cost than on data. Livzon has ready-made dermatology and rheumatology commercial networks, its own capacity, and cost resilience from localized raw materials. When rivals are fighting a price war, whoever has lower manufacturing costs can hold out longer — precisely Livzon's home turf.

Fourth, expedited review has narrowed the time gap. Priority review lets it be approved as early as H1 2027. Although two or three years behind domestic single-target IL-17As and about a year behind bimekizumab's psoriasis approval, the combination of "dual-target + domestic + affordable" still has a chance to take a bite out of a market that is not yet saturated and still expanding.

Fifth, the second indication is an underrated second growth curve. Ankylosing spondylitis in China is likewise a patient pool in the millions, mainly young and middle-aged men, with a long disease course and sticky drug use — once on an effective biologic, treatment often continues for years. More importantly, IL-23, the biggest competitor in psoriasis, cannot get into the AS market at all, leaving TNF inhibitors and same-class IL-17As as the main rivals. Laikangqitamab's AS data (ASAS40 response rate of 45.5% at Week 16, holding up in patients with and without prior TNF inhibitors) are solid enough, with the marketing application expected to be filed within 2026. While psoriasis is a close-quarters fight on the front line with IL-23 and domestic single-target drugs, the relatively quieter and stickier AS front may be the more stable source of profit. Winning prescriptions in both dermatology and rheumatology would raise the commercial ceiling for a single molecule significantly.

In discussions of domestic innovative drugs, manufacturing is often glossed over, but it is frequently the hidden thread that decides life or death in a price war. Here, laikangqitamab holds a hand others envy.

The licensee, Livzon Mab, has a mature platform for large-scale antibody cell culture and purification and a commercial biologics base, and uses digital twin technology to support process scale-up. This means drug substance and drug product are all produced in-house, with no reliance on external contract manufacturing, and continuity and quality of the supply chain are in its own hands. Supply for the Phase 3 trials of both indications, including the psoriasis study with 52 weeks of long-term dosing, never had problems — itself indirect proof of industrialization capability.

More crucial is cost. Livzon repeatedly stresses in public statements that it actively lowers manufacturing costs through localization of raw materials, in-house substitution of core raw materials, process optimization and loss control. In a market where peers have already been squeezed to RMB 700–800 a vial, cost is the moat for gross margin, and the confidence to concede on price in NRDL negotiations. When others struggle in the price war under cost pressure, own capacity + localized raw materials may be the invisible advantage that lets laikangqitamab outlive its rivals.

This molecule's timeline is completely different from the typical biotech's "race against financing milestones". Because the licensee is a large listed pharma company, it has no hard runway constraint — no need to force a beautiful readout before a financing round runs out, and no need to be forced to sell overseas rights at a valuation peak. This gives it a rare strategic luxury: patience.

This patience directly rewrites the optimal solution for overseas licensing. For a cash-strapped biotech, "selling overseas rights for cash while the data are hot" is often a forced choice; but for laikangqitamab, overseas licensing is upside icing on the cake, not a lifeline. It can wait until psoriasis is approved in China and the AS marketing application is filed, bundle "two indications + dual-target mechanism + cost advantage" into a more valuable package, and then negotiate at leisure.

The timeline is roughly as follows: psoriasis entered the clinic in 2019, both Phase 3 trials started in 2023 with key regulatory communications completed, AS data were unblinded at the end of 2024, the psoriasis head-to-head read out in mid-2025 and the marketing application was accepted at year-end, and priority review was granted in early 2026 — if all goes well, psoriasis approval in H1 2027, followed by the NRDL negotiation window, with the AS marketing application expected to be filed within 2026. The negotiation window for overseas licensing is open from now on.

Any optimistic judgment should keep a "retreat button". For laikangqitamab, if any of the following happens, the logic above needs rewriting:

• NRDL negotiation fails or forces a steep price cut. If the value of "dual-target superior to single-target" cannot be converted into a reasonable price at the negotiating table, and it is forced onto the NRDL at the floor price of domestic single-target drugs, then even the cost advantage of own capacity cannot rescue profits, and the appeal of the whole commercial story will be greatly diminished.
• In the real world, the dual-target advantage over single-target fails to persist. The head-to-head win was in the idealized population of a clinical trial; if after launch, in more complex real patients, the efficacy gap narrows to where physicians cannot perceive it, the premium narrative of "dual-target" will bleed.
• New safety signals appear. Same-mechanism bimekizumab has a known class-effect weakness — higher rates of fungal adverse events such as oral candidiasis than single-target drugs. Laikangqitamab's current safety description is "comparable to control", but whether similar issues emerge after long-term, large-sample exposure deserves ongoing vigilance.
• Overseas licensing stalls. If no multinational buyer is willing to pay a decent upfront for an asset "with no head-to-head against the global benchmark and purely Chinese data", the assumption that "overseas is upside" will have to be discounted, and the molecule's value ceiling will be pushed back to the Chinese market alone.

Laikangqitamab is a somewhat paradoxical case. As a molecule, it has a solid mechanism, beautiful data, self-controlled manufacturing and no money worries — almost the most complete "hardware" among domestic innovative drugs; but as a race, it has stepped into China's most crowded and price-cutthroat autoimmune battlefield, with the imported originator's head start in front, the NRDL price wall of domestic peers beside it, and fog still hanging over the overseas road.

Its decisive factor lies not in the lab but in the last mile: whether it can translate the clinical value of "dual-target superior to single-target" into a decent price at the NRDL negotiating table, then use Livzon's channels and costs to win back share inch by inch. It won't be the kind of story that goes viral overnight, but with the luxury trump card of "no cash pressure", it is qualified to fight a patient, pragmatic war of endurance. In an era of Chinese innovative drugs that increasingly competes on "the last mile", this may be the way of surviving more worth learning from.