The leading player in pharmaceuticals, five major catalysts are coming strong

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Hengrui Medicine released its annual report yesterday, which is quite good for the company. In the revenue structure, innovative drugs are quietly replacing generics step by step. For details, see “2026-2035, Jerry Wants to Discuss the Next Decade with Hengrui Executives.”

However, I believe there is one crucial point that hasn’t been unpacked: the progress of Hengrui’s ADC pipeline.

In China, when it comes to pipelines focusing on tumors, ADCs are the shining gems in the crown of innovative drug development. Hengrui’s ADC platform is the most dazzling gem among them. Its ADC platform not only has a broad target layout but also boasts replicable data, unlike Daiichi Sankyo’s DS-8201, which is fleeting.

This year, Hengrui is expected to read out the phase III clinical results for five ADC pipelines, and 2026 may be a breakout year for ADCs in the pharmaceutical industry.

Hengrui’s SHR-A1811 is already on the market. Its structural adjustments and the resulting improvements in efficacy and safety are evident. Surprisingly, a small cyclopropyl group has led to such significant improvements. Now, Hengrui is following the same mold, using the same linker and payload to create the five shining stars in the phase III clinical trials. They will be significant incremental commercial gains for Hengrui in the next five years.

(Source: UmabsDB)

1) SHR-A1811

Let’s start with SHR-A1811. We all know its recent big news; it’s going head-to-head against the product sitting on the Iron Throne—DS8201. Whether it has the capability can be compared by looking at the data of both.

The DAR value of DS8201 is 8, while SHR-A1811 has been optimized to a DAR of 5.7. Additionally, in terms of plasma stability, SHR-A1811 is more stable than DS-8201, with a 21-day plasma release rate of toxins less than 1%, while DS8201 reaches 1.2%-3.9%.

In clinical data, shoulder-to-shoulder comparison shows that A1811 outperforms 8201. Not only does it exceed DS8201 in ORR and mPFS, but more importantly, it addresses the longstanding issue of interstitial pneumonia associated with the dxd platform.

As shown in the figure below, the incidence of interstitial pneumonia for 8201 reached 14.9%, while A1811 demonstrated an incidence of only 5% in its phase II single-arm trial. In the treatment of NSCLC mutations in later lines, A1811 excels in both efficacy and safety compared to 8201. For breast cancer data, A1811 currently lacks mature large sample data, so we will hold off on that for now.

The sales figures for Her2 ADC need not be elaborated on, and the first batch of SHR-A1811 targets lung cancer indications. The peak sales for DS8201 have been estimated to exceed $10 billion. Objectively speaking, SHR-A1811 is Hengrui’s second Car-T, and it’s highly likely that future sales will reach 4-5 billion RMB.

2) SHR-A1921

The second pipeline is also a frequently mentioned target—TROP2, pipeline A1921. What’s interesting about this pipeline is that it doesn’t follow the usual TROP2 path, which typically targets triple-negative breast cancer and NSCLC. Instead, A1921’s first phase III trial is for ovarian cancer indications.

All clinical data comparisons are shown in the figure below. To be honest, the results in platinum-resistant ovarian cancer are quite impressive, with the dose group of 2.0+2.0 mg/kg showing an ORR of 58.8% and an mPFS of 7.2 months, despite a very poor baseline: 78.3% of patients had received ≥2 lines of platinum chemotherapy; 45.7% had undergone ≥1 line of non-platinum chemotherapy after being diagnosed with platinum resistance.

In comparison, AbbVie’s golden ADC for ovarian cancer targeting FRα, Mirvetuximab, has a phase III ORR of 41.9% and an mPFS of only 5.59 months. Moreover, this drug causes significant short-term ocular toxicity that requires glucocorticoids for relief. Importantly, FRα ADCs can only be used in patients with high expression of the target, which constitutes about 30% of ovarian cancer patients, whereas TROP2 is notorious for being universally applicable, without the need for patient selection based on expression.

(SHR-A1921 Clinical Data)

This TROP2 pipeline may not be assigned a very high valuation, as SKB264 is exceptionally strong, and SHR-A1921 targets ovarian cancer, which is not a large indication. Furthermore, Mirvetuximab’s global peak sales are estimated to be quite low, around $600 million. In China, ovarian cancer drugs have only moderately performed, with Niraparib peak sales around 1 billion RMB.

3) SHR-A1904

The third pipeline targets Claudin18.2, a target many should be quite familiar with. The data for SHR-A1904 at a dose of 6 mg/kg shows decent performance in high-expressing patients (≥50% tumor cells 2+/3+), with an ORR of 55.6%. This ORR is quite high, with moderate expression requirements for patients.

In comparison, Innovent’s IBI343 has stricter requirements of ≥75% tumor cells ≥2+, and the data shows that the 8 mg/kg group has an ORR of 47.1%. However, Innovent has its advantages; its Fc region is engineered to avoid gastrointestinal ADCC effects, so the incidence of grade 3 and above gastrointestinal reactions is very low (<5%), with no cases of interstitial lung disease reported.

As for those with lower expression requirements, we won’t mention the extraordinarily impressive ones, but Konno’s CMG901 requires ≥20% tumor cells ≥2+, with the 2.2 mg/kg dose group showing an ORR of 42%. This may be due to the use of MMAE toxins, resulting in less impressive observer effects, leading to lower ORR and DCR (short-term tumor shrinkage effect). Moreover, MMAE has specific toxicities, such as neurotoxicity.

Many have already speculated on the peak sales of Claudin18.2 pipelines. According to Huachuang Securities’ predictions, CMG901’s peak sales are expected to reach 2.793 billion RMB by 2033.

4) SHR-A2009

The fourth pipeline is Hengrui’s HER3-targeted SHR-A2009. Daiichi Sankyo’s ADC targeting the same point has stumbled in lung cancer indications. Currently, a point of interest is that Hengrui’s HER3 ADC pipeline has received FDA fast track designation for lung cancer. However, as we know, although Hengrui’s SHR-A2009 performs well, there is a leading competitive dual-target ADC in the domestic market—iza-bren, which has exceptionally good data. BL-B01D1 is also a significant indirect beneficiary after the failure of HER3-DXd; its EGFR × HER3 dual-target mechanism offers a more reasonable biological hypothesis—by simultaneously blocking the EGFR signaling pathway and HER3-mediated escape signals, it hopes to translate PFS improvement into OS benefits.

In 2026, Hengrui’s HER3 ADC is expected to read out phase III clinical data in a population after EGFR TKI resistance. However, to be honest, this population already has relatively mature treatment options, with immunotherapy like AK112 and ADC like SKB264. For now, we can only hope that the HER3 ADC shows better mPFS data than SKB264, though it is quite challenging.

This pipeline is difficult to make market predictions for.

5) SHR-A2102

The fifth pipeline is Nectin-4 targeted SHR-A2102. This drug’s first phase III trial is similar to Padcev, targeting urothelial carcinoma (UC). However, it is well known that Padcev is developed on the Seagen platform, using MMAE as its toxin, while SHR-A2102 also employs MMAE. The issue remains that short-term tumor shrinkage effects may not be very impressive. Interestingly, Maiwei Bio’s 9MW2821 shows exceptionally good ORR, with mPFS and mOS both performing excellently.

Unfortunately, SHR-A2102 may not be the best in class for this target. By 2026, not only will A2102’s phase III clinical data be read out, but 9MW2821’s phase III clinical data will also be forthcoming. Currently, the main focus is on the combination of Nectin-4 ADC with PD-1 monoclonal antibodies. For instance, the combination of 9MW2821 with Toripalimab in first-line UC patients achieved a cORR of 80%. Meanwhile, Padcev combined with Pembrolizumab’s first-line phase III ORR was 67.7%, and its final mOS reached 33.8 months, showing a significant tail effect.

However, Hengrui also launched a trial last month for SHR-A2102 combined with PD-L1 in first-line UC treatment, although the progress is a bit slower. Hengrui may carve out a unique market for itself with its differentiated payload.

According to Galaxy Securities’ predictions, the peak sales for 9MW2821 in urothelial carcinoma indications will exceed 1.7 billion RMB.

6) SHR-A1912

The sixth pipeline is CD79b-targeted SHR-A1912, primarily indicated for r/r DLBCL, sometimes used in combination with R-GemOx. Its main goal is to surpass Roche’s Pola, marking another instance of DXD toxin’s advantage over early MMAE in terms of efficacy. In combination scenarios, the ORR and CR rates are significantly higher. Moreover, the Pola-R-CHP regimen has a reported peripheral neuropathy rate of 52.9%, whereas SHR-A1912 does not present neuropathy issues, with only 1 case of ILD in small sample trials.

To be honest, for r/r DLBCL, CD79b ADC is a solid choice, with high ORR and CR rates. Even the Pola regimen has a CR rate of 40.3%, while the CR rate for CD19 ADC is below 50% (though it has been approved for monotherapy), and TCE’s current CR rate is around 30%, which is not as good as CD79b ADC.

It can be said that among patients unsuitable for transplantation, ADC remains the first choice. However, a dark horse has recently emerged: the CD19 monoclonal antibody Tafasitamab from Innovent, which, when combined with Lenalidomide, achieved an ORR of 57.5% and a median PFS of approximately 11.6 months, demonstrating remarkable efficacy, even outshining the Pola combination therapy. This will likely become A1912’s primary competitor.

There are no domestic counterparts for this; we can only reference foreign products. The peak sales for Pola are expected to reach $3 billion.

Conclusion: This is the situation regarding Hengrui’s five shining stars to be read out in 2026. Overall, it’s a case of both following trends and facing challenges. Hengrui has more completely capitalized on the dxd platform’s benefits compared to Daiichi Sankyo, but it also faces formidable competitors in different targets. These competitors are not following Daiichi Sankyo’s platform but are still performing quite well. In the next era, differentiated innovation will ultimately be the mainstream.

However, given Hengrui’s domestic commercialization capabilities, even if these pipelines are not BIC or Me-better, occupying a position can still yield substantial sales, provided the safety profile is not severely compromised.