One Molecule, Two Names, Two Destinies

HRS-1893 is a selective, reversible inhibitor of cardiac myosin ATPase, given as an oral tablet. Its logic is straightforward: the core pathology of HCM is cardiac hypercontractility. Dialing down the frequency of myosin–actin binding brings contractility back down, relieves left ventricular outflow tract (LVOT) obstruction and improves diastolic compliance at the same time.

This path has already been walked successfully twice. BMS's mavacamten (Camzyos®) was the world's first approved cardiac myosin inhibitor; it was approved in China in 2024, added to the National Reimbursement Drug List (NRDL) in that year's update, and reimbursed from January 1, 2025. Cytokinetics' aficamten was the second, approved by China's regulator on December 17, 2025 to improve exercise capacity and symptoms in adults with NYHA class II–III obstructive HCM; in February 2026 it was also approved in the EU.

This means that for HRS-1893, the most expensive question — "can this mechanism become a drug?" — has already been answered with someone else's money. All of the remaining risk sits with the molecule itself: whether it is faster, easier to use and cheaper, and whether it can squeeze into a market where others have already taken their positions.

That cuts both ways. A validated target means buyers are willing to bid, but it also means buyers hold a ready-made yardstick. When a class already has two marketed drugs, a buyer can price your molecule directly off their sales curves, and it is hard to extract a premium for "possibly better" — the market only pays for "already better".

The molecule's most solid selling point is speed of onset. In the Phase 1 study presented at the 2025 European Society of Cardiology Congress, obstructive HCM patients saw mean resting LVOT gradient fall by 91.0% by Day 5 (from 71.2 mmHg to 6.0 mmHg) and the Valsalva gradient fall by 87.4% (from 66.6 mmHg to 8.0 mmHg), sustained throughout dosing. Pharmacokinetically, steady state was reached by Day 8, with accumulation ratios of 1.30 for Cmax and 2.04 for exposure. A dose-related decline in ejection fraction was observed in healthy volunteers, and that is precisely why investigators set 60 mg as the starting dose for patients.

Phase 2 results in the obstructive population were released on March 30, 2026: 42 patients, multicenter, randomized, open-label, 12 weeks, titrated in three arms (20 mg BID titrated to 60 mg; 40 mg BID titrated to 80 mg; 40 mg QD titrated to 120 mg). The primary endpoint was change in Valsalva gradient from baseline to Week 12; the proportion of patients achieving complete response (gradient below 30 mmHg) ranged from 50% to 86% across arms, with effects visible by Day 5. On safety, mean ejection fraction fell by 1.8% to 2.7%, no patient dropped below 55%, and no one discontinued due to adverse events.

Phase 2 results in the non-obstructive population were released on May 11, 2026: 84 symptomatic patients, multicenter, randomized, double-blind, placebo-controlled, with high-dose, low-dose and placebo arms. There is a framing issue that must be stated plainly here — the primary endpoint of this study was safety and tolerability, not efficacy. Every efficacy figure is secondary or exploratory.

Putting these numbers together, the reasonable judgment is this: the molecule's pharmacodynamic signal is clean, with biomarkers, cardiac structure and diastolic function all moving in the right direction; on clinical benefit, what it has is directional evidence at Phase 2 scale, not a confirmatory conclusion at Phase 3 scale. The two Phase 2 studies enrolled 42 and 84 patients respectively, and the obstructive one was open-label, so effect sizes are likely optimistic and Phase 3 expectations should be actively revised downward.

Non-obstructive HCM has long been regarded as the biggest open field in this class: patients have no outflow obstruction, so the gradient surrogate endpoint does not apply and improvement in symptoms and exercise capacity must be demonstrated directly. Whoever proves it first opens up a new indication.

On April 14, 2025, BMS announced that mavacamten's ODYSSEY-HCM study missed its dual primary endpoints. The study enrolled 580 symptomatic non-obstructive patients; the dual primary endpoints were change in KCCQ Clinical Summary Score and peak VO₂ from baseline to Week 48. Post-hoc secondary analyses showed improvements in cardiac biomarkers and echocardiographic remodeling measures, but the functional and symptom endpoints did not come through.

On May 5, 2026, Cytokinetics announced that aficamten's ACACIA-HCM study met its dual primary endpoints. 516 patients were randomized 1:1; at Week 36, the between-group difference in KCCQ Clinical Summary Score was +3.0 (p=0.021) and in peak VO₂ was +0.67 mL/kg/min (p=0.003; +0.64 on drug vs −0.03 on placebo). Multiple key secondary endpoints had p-values below 0.001. On safety, 10% of patients had an ejection fraction below 50% vs 1% on placebo; two patients on drug had serious heart-failure events with ejection fraction below 50%, and 3% interrupted treatment for ejection fraction below 40%.

There is another discipline that must be kept: HRS-1893's Phase 2 KCCQ +5.5 points and peak VO₂ +0.9 mL/kg/min cannot be compared directly with ACACIA-HCM's +3.0 and +0.67. The sample sizes differ six-fold, the follow-up durations differ, the enrolled populations and baseline states differ, and the statistical framing differs too. The only thing a cross-trial comparison can say here is that effect sizes in the non-obstructive indication are generally modest, and nobody has produced overwhelming numbers.

Conversely, that is also the challenger's only remaining opportunity. ACACIA-HCM's effect size is not large; if HRS-1893's global pivotal study can deliver a bigger difference on the same endpoints, the ranking could still flip. What that requires is a precisely designed Phase 3, not a pretty Phase 2.

Hengrui retained the China rights, and this part belongs entirely to it. But the timeline arithmetic for the Chinese market needs to be laid out.

In China's obstructive HCM market, mavacamten was approved and added to the NRDL back in 2024, and aficamten was approved in December 2025 — its Greater China rights were acquired by Sanofi from Ji Xing Pharmaceuticals in December 2024, meaning that in China this molecule is backed by a multinational's commercial infrastructure.

HRS-1893's China timeline looks like this: the Phase 3 study in the obstructive indication started on August 11, 2025, enrolling 216 patients, with a registered primary completion date of September 2026. On a normal review timeline, the marketing application could be filed in 2027 at the earliest, approval would land around 2028, and NRDL negotiation would come in 2028–2029 at the earliest.

About four years behind the leader. The practical consequence of that gap is not "launching a bit later" — it is that the price anchor has already been nailed down by the first two rounds of negotiation. A later domestic molecule faces a market with existing NRDL coverage and a clear price band; pricing freedom is close to zero, and the only weapons left are lower prices and faster hospital listing.

Are expedited pathways available? No Breakthrough Therapy Designation or priority review notice for this product was found through public channels. A caveat is needed here: "not found" does not mean "does not exist"; this kind of information needs to be confirmed directly on the drug review agency's public notice pages. But logically, with two approved drugs already in the obstructive indication, the "urgent clinical need" rationale that expedited pathways rely on has indeed been weakened. By contrast, the non-obstructive indication still has no approved drug in China, and if filed separately it has a better chance of regaining expedited eligibility.

There is another easily overlooked structural advantage on the China side: all of this molecule's key data were generated in China to begin with — Phase 1 (76 patients), obstructive Phase 2 (42), non-obstructive Phase 2 (84), Phase 3 (216) and a long-term safety study (300), all sponsored in China by Hengrui's subsidiary Shandong Suncadia Medicine. Chinese registration does not need to wait for any overseas data — one of the few natural advantages domestic assets have.

Hengrui's 2025 report card: revenue of RMB 31.629 billion, up 13.02% year on year; net profit attributable to shareholders of RMB 7.711 billion, up 21.69%; R&D spending of RMB 8.724 billion, over 27% of revenue; innovative drug sales of RMB 16.342 billion, up 26.09% and 58.34% of drug sales; out-licensing income of RMB 3.392 billion, up 25.62%; operating cash flow of RMB 11.235 billion, up 51.36%. Its commercial network covers more than 25,000 hospitals and 200,000 retail pharmacies.

In cardiovascular, the company already had its first Class 1 innovative drug, recaticimab (Aixin'an®), in January 2025 — the world's first ultra-long-acting PCSK9 antibody, dosable as infrequently as every 8 weeks. That team has already built out cardiology coverage.

This is the most concrete meaning of "platform amplifies product": HCM is an indication whose patients are highly concentrated in the cardiology departments and specialty centers of tertiary hospitals; the number of target hospitals is limited, making it one of the few diseases that can be "fully covered". Once the cardiology team, formulary committee channels and academic resources have already been built for a lipid-lowering product, the marginal selling cost of adding a cardiomyopathy product is very low. For a small-population product, this is almost the only way to make the numbers work.

But this lever has two limits that must be acknowledged.

First, the synergy stays at the channel level, not the prescribing level. The profile of lipid-lowering prescribers does not fully overlap with that of HCM prescribers — the former are broad chronic-disease managers, the latter a small number of subspecialty experts. Sharing a team saves call costs but does not create prescribing linkage. And when the same team carries a lipid-lowering product with far larger sales, the small-population product being sidelined in sales attention is a common outcome for such combinations.

Second, the payer-side evidence is empty. There is currently no head-to-head study against the incumbent drugs and no public Chinese pharmacoeconomic evidence. And the comparator in NRDL negotiation is precisely the same-class drug already on the list. Without comparative evidence, the only bargaining chip left at the table is price. The cost structure of an oral small molecule is indeed much friendlier than that of imported antibodies, leaving room to trade price for volume — but if the entire cost advantage is ceded to the payer, even large sales will struggle to turn into profit.

So the truly realistic playbook on the China side is "fast hospital listing + price-for-volume + retaining share through follow-up stickiness". Ejection fraction management requires tied-in echocardiographic follow-up, which is both a burden and a source of stickiness. If the two features of fast onset and minimal titration can be translated into fewer echo check-ups and a shorter titration period, that would be the only difference that can be written into the label and genuinely felt by physicians.

The terms announced on September 5, 2025: an upfront payment of US$65 million, of which US$32.5 million in cash and US$32.5 million in Braveheart shares; up to a further US$10 million upon completion of technology transfer, for total initial consideration of up to US$75 million; development and commercial milestones of up to US$1.013 billion; plus royalties on net sales. Upfront plus the milestone cap totals about US$1.088 billion.

Now look at the timing. The China Phase 3 started on August 11, 2025, and the deal was signed on September 5 — 25 days apart. The obstructive Phase 2 results were only released on March 30, 2026 and the non-obstructive Phase 2 results on May 11, 2026 — roughly seven and eight months after signing respectively. In other words, Hengrui sold the global rights outside Greater China as a whole before either Phase 2 readout was made public.

This needs to be judged fairly. Saying "it was sold too cheaply" because the data turned out well is classic hindsight. At signing, public clinical evidence only went as far as Phase 1; the buyer took on the full risk that Phase 2 might disappoint, and in the cardiac myosin class that risk is far from hypothetical — mavacamten's non-obstructive Phase 3 failed after that point. Risk transfer comes at a price; that is the symmetry of a licensing deal.

What is really worth discussing is not the price but the irreversibility of the structure. This deal bundled every territory outside mainland China, Hong Kong, Macau and Taiwan to a single partner in one go, without splitting by region into the US, Europe, Japan or emerging markets, and without retaining an opt-in to self-commercialize in any territory. What bundling bought was speed and the execution certainty of a single counterparty; the price was losing, from then on, any chance to re-price and any control over the path. Overseas value can only flow back through three passive pipes: milestones, royalties and the equity stake.

Compare another deal using the same NewCo model: in May 2024, Hengrui licensed the ex-Greater China rights to three GLP-1-related products to a company later renamed Kailera, obtaining, in addition to the upfront and milestones, a 19.9% equity stake. In its own announcement the company framed the HRS-1893 deal as its "second collaboration with international investment institutions in less than 18 months". This shows it was not an opportunistic asset monetization but a model being pushed as replicable.

Productizing the model has its own cost: once licensing income becomes a predictable, routine revenue line — RMB 3.392 billion in 2025, up 25.62% — the company may systematically lean toward giving away overseas rights early, because that is the easiest to monetize, not because it maximizes value. This is the point that should be pressed hardest in every "NewCo model" narrative.

One detail is worth noting: a bioequivalence study between two formulations started on April 14, 2026, with 58 subjects and expected primary completion in July 2026 — two months before the Phase 3 primary completion. This indicates a change between the clinical-trial formulation and the intended commercial formulation, and the company scheduled the bridging ahead of the key readout. That is standard practice and homework that must be done; if equivalence is not achieved, the CMC dossier for the China marketing application would have to be reorganized.

The supporting clinical pharmacology package is also complete: a dedicated study of verapamil's effect on the drug's PK (14 subjects) is complete, a food-effect and relative bioavailability study (38 subjects) is complete, and a human mass-balance study has been registered. HCM patients routinely take beta-blockers and calcium channel blockers concomitantly, and interaction data will go directly into the label — if some common concomitant medications ultimately have to be restricted, the practically treatable population would shrink markedly. The company clearly anticipated this and did the homework early.

On the supply side, there is something that needs careful wording. The license agreement granted manufacturing rights together with development and commercialization rights, and provided for a technology transfer payment of up to US$10 million. "The partner holds manufacturing rights" does not mean "the finished product will necessarily be made by Hengrui"; once technology transfer is complete, Hengrui's indispensability in the overseas supply chain will decline. Long-term income from this part should not be assumed.

There is also an independent risk: if overseas filings use a Chinese manufacturing site, that site will need to pass on-site inspection by foreign regulators. There are already precedents in the industry of domestic assets being held up in overseas filings because of site issues, and such risks have nothing to do with clinical data quality. A cross-border structure where control sits with one party and regulatory responsibility with another is the most likely to produce a responsibility vacuum when things go wrong.

Company public materials show 10 pipeline products in cardiovascular, three of which are in Phase 2 or later, HRS-1893 being one of them. Within the cardiovascular line it is in the first tier; but at company level, the bulk of the RMB 16.342 billion in innovative drug revenue is still in oncology, and in China this molecule is destined to be a small-population product.

That has two consequences. The good one is that it will not be cut internally — cardiovascular and oncology barely overlap in trial sites, investigators or sales teams, their resource pools are independent, and the China-side investment (a 216-patient Phase 3 and a 300-patient long-term safety study) is negligible relative to RMB 8.724 billion in R&D spending, so failure would not materially affect overall results. The bad one is that precisely because the investment is small and expected revenue limited, the company's incentive to push up the upfront at the negotiating table was correspondingly weak. This may be the most honest way to understand the deal terms.

There is also a widely underestimated direction: heart failure with preserved ejection fraction (HFpEF). A Phase 2 study of the molecule started in China on March 30, 2026, enrolling 48 patients, with a registered primary completion date of March 2027. The patient population in this indication is an order of magnitude larger than HCM, and so far no cardiac myosin inhibitor has staked out a position there.

But two buckets of cold water are needed. First, the mechanistic hypothesis in this indication differs from HCM — HFpEF patients do not universally have excessive contractility, so using a contractility-suppressing drug here needs stronger mechanistic justification, and a 48-patient early study is far from enough to support an expansion narrative. Second, and more practically: the public deal terms are not split by indication, so the ownership of overseas rights in this direction must follow the original agreement text; one cannot simply infer a conclusion from the phrase "worldwide rights excluding Greater China".

Back to the opening contrast. In eleven months the buyer turned a US$65 million entry ticket into US$380 million of public-market financing; that value creation came from two Phase 2 readouts, one successful capital-markets operation, and a valuation environment for the entire cardiac myosin class re-ignited by aficamten's success. Part of that value rightly belongs to the party that bore the risk.

But the real lesson of this deal is not about price. It is this: ceding all rights outside the home market in one go, with no territorial split and no recapture clause, amounts to handing the long-term fate of this molecule to a newly formed company that has never run a global pivotal study. From then on, whether the partner runs fast or slow, designs well or badly, gets acquired or pivots, Hengrui can only watch from the sidelines. And on the China side, the fight for share must still face positions already built by two multinationals.

On the molecule itself, the verdict can be stated clearly: the mechanism risk has been cleared, speed of onset is a real differentiator, China R&D execution efficiency is a real advantage, and the CMC and clinical pharmacology homework is more solid than for most domestic Class 1 innovative drugs. Its problem was never "can it become a drug", but "in a market where others are already in position, what does the third entrant live on".

The answer to that question will not appear in Nasdaq's opening price. It will appear in the September 2026 readout, and in how the China team uses the three-year head start over overseas markets.