2025 Interim Results Presentation
1 st S e p t e m b e r, 2 0 2 5
Agenda
Interim Results Overview
R&D
Financial Review
Q&A
3
01 Interim Results Overview
4
2025 Interim Results Overview
Revenue
Net profit attributable to owners of the parent
EBITDA
4.4 Bn RMB Maintained stable
1.4 Bn RMB YOY 24.6%
1.8 Bn RMB YOY 11.6%
4.4
4.4
1.1
1.4
1.6
1.8
2024H1
2025H1
2024H1
2025H1
2024H1
2025H1
5
Financial Structure Further Optimized;
Cash Resources Support Long-Term Development
30+
R&D Pipeline
Candidates
Active R&D investment
30+ R&D pipeline candidates, and more early-stage drug targeting innovative targets
FDA EMA
GMP
Repaid Panda Bonds
1.2 Bn RMB
Bank loans decreased by
440 Mn RMB
Global Quality System
Establish high-quality biologics DS & DP manufacturing lines, build a global supply chain system for biologics, ensuring global pharmaceutical supply, improve global commercialization capability
10+
New Drugs Ready
for Launch
New Products Marketing
Enhance academic promotions and marketing
work for new launched drugs
6
Interest-bearing liabilities and bonds decreased from 3.5 Bn RMB 2024 year-end to
1.9
Bn RMB
Finance costs decreased by
49%
Comprehensive finance costs
positively contribute
31 Mn RMB
Gearing ratio decreased from 19.7%
2024 year-end to
9.9%
Core Products Overview
TPIAO
Recombinant human
thrombopoietin
( rhTPO ) injection
RMB Mn
3,397
4,205
2,371
-4.2% YOY
Revenue: 2.4 Bn RMB
5,062
2022 2023 2024 2025H1
Mandi
Minoxidil tincture, foam , and extended products like Mandi shampoo
RMB Mn
894
1,124
1,337
682
24.0% YOY
Revenue: 680 Mn RMB
2022 2023 2024 2025H1
Sunshine Guojian
Subsidiary Sunshine Guojian products including Yisaipu, Cipterbin, and Xenopax
RMB Mn
825
1,014
642
7.6% YOY
Revenue: 642 Mn RMB
1,194
2022 2023 2024 2025H1
7
Accelerate International Footprints
4 10+ 35+ 70%products sold overseas
EPIAO
Yisaipu
SEPO
TPIAO
international GMP certificates
GMP system of manufacture plant certified by US, Brazil, Colombia, Egypt, Thailand etc.
covered international markets
50 SKUs obtained marketing approval document from 20+ countries
70+ SKUs waiting for approvals by 10+ regulatory agencies
YOY revenue from overseas
Outstanding quality of drugs and clinical data support
Excellent supply chain system and commercial partners
8
Our Partnership with Pfizer
707: PD-1&VEGF Bispecific Antibody A Potential Next-generation I/O Therapy
1.25
US$bn
4.8+ Double
100
up to 150
US$bn
-Digit
US$mn
US$mn
Up-front Payment Milestone Payment Royalties Share Purchase Opt-in
Largest global ex-China
9
Including development, regulatory and sales milestones
Tiered based on accumulated net sales
Upon Completion
to develop,
and commercialize SSGJ-707 in China
Marks a total combined upfront transaction value of $1.5bn
707: Unique Molecular Structure
Bispecific Antibody with Tetravalent Structure
Cooperative Binding | Potentially Localized Activity | Unique IgG4 Fc Region |
PD-1 binding affinity increased | Due to high VEGF levels in | Potentially decreasing unwanted |
100X in presence of VEGF | tumors, may confer safety | immune activation |
advantages |
Tetravalent structure show superior efficacy vs.PD-(L)1 checkpoint inhibition alone
Potentially best-in-class anti-angiogenic activity and high affinity for PD-1
Compelling Ph 1/2 Clinical Data as both monotherapy and in combination with chemotherapy in NSCLC and mCRC
SSGJ-707: Potentially Transformative MOA
IgG4 Fc region
10
707: Preclinical Data Shows Best-in-Class Potential
Improved VEGF Binding Affinity Improved PD-1 Binding Affinity
coat: VEGF165-his 1µg/mL coat: PD1-his 2µg/mL
Stronger Inhibition of HUVEC Proliferation
140
OD450(nm)
3
2
1
0
10 -2
10 -1
10 0
10 1
10 2
10 3
10 4
3
OD450(nm)
2
1
0
10 -2
10 -1
10 0
10 1
10 2
10 3
10 4
90
Control Growth (%)
40
(10)
10 -3
10 -2
10 -1
10 0
10 1
10 2
Conc.(nM) Conc.(nM) Conc.(nM)
707 Drug A
707 Drug A
VEGF165 Mean (nM) SD
P1 (nM)
P2
(nM) Top Bottom
PD-1 Mean (nM) SD
P1 (nM)
P2
(nM) Top Bottom
HUVEC Mean (nM) SD
P1 (nM)
P2
(nM) Top Bottom
707 | 1.394 | 0.119 | 1.31 | 1.478 | 0.020 | 2.330 |
Drug A | 1.434 | 0.071 | 1.484 | 1.383 | 0.031 | 2.432 |
707 | 2.661 | 0.070 | 2.611 | 2.710 | 0.014 | 2.287 |
Drug A | 6.137 | 0.012 | 6.128 | 6.145 | 0.006 | 2.320 |
707 | 0.465 | 0.036 | 0.440 | 0.491 | 93.06% | (4.63%) |
Drug A | 3.573 | 0.381 | 3.303 | 3.842 | 86.69% | 20.19% |
Significant VEGF and PD-1 Inhibitory Effects
707 has shown no adverse safety effects on the cardiovascular or respiratory system, with NOAEL of 150 mg/kg after repeated doses
In Vivo VEGFi Efficacy: In Vivo PD-1i Efficacy：
Superior inhibition at
4.8mg/kg compared to compared group at 4 mg/kg
Hela MC38
Tumor Volume (mm3)
Tumor Volume (mm3)
2000
1500
1000
500
0
0 5 10 15 20 25 30
1400
1050
700
350
0
Superior inhibition at
1.8mg/kg compared to compared group at
1.5 mg/kg
0 5 10 15 20
Days Post Treatment Days Post Treatment
Control SSGJ-707 4.8 mg/kg Drug A 4 mg/kg SSGJ-707 24 mg/kg Drug A 20 mg/kg
11
Control SSGJ-707 1.8 mg/kg Drug A 1.5 mg/kg SSGJ-707 18 mg/kg Drug A 15 mg/kg
707: Encouraging Data for Ph II of Monotherapy NSCLC
Manageable
Deep and Durable Responses with cORR of 64.7% Safety Profile Generally
10 mg/kg SSGJ-707 Administered Once Every Three Weeks (N=34)
Adverse events: 10 mg/kg Q3W(N=34)
Treatment-related AE | 33 (97.1%) |
Grade ≥3 TRAE | 8 (23.5%) |
TR SAE | 7 (20.6%) |
TRAE leading to drug discontinuation | 1 (2.9%) |
Treatment-related death | 0 |
Source：3SBio ASCO data, Pfizer
12
707: A Potentially Transformative MOA
100%
80%
60%
Similar Benefit Rates Across
Squamous and
Non-squamous Subtypes
100% 96%
75%
64%
100%
80%
60%
Similar Benefit Rates Across
Levels of
Tumor PD-L1 Expression
95% 100%
77%
62%
40%
40%
20%
20%
0%
SQ （N=12） NSQ （N=22）
ORR DCR
0%
TPS 1-49% （N=21） TPS ≥50% （N=13）
ORR DCR
Results demonstrate potential to address historically challenging squamous andPD-L1 low patient populations
Source：3SBio ASCO data, Pfizer
13
707: Pfizer is Actively Promoting Global Development
Near-Term Objectives
Capitalize on momentum and jumpstart global Phase 3 development in NSCLC and other solid tumors
Explore 707 in Thoracic, Genitourinary, Gastrointestinal and other multiple tumor types and combination opportunities including with Pfizer's ADCs
Explore 707 in multiple tumor types and combination opportunities
>50
Medical oncologists across clinical development and medical affairs
45
Countries, and over 4,000 sites, participating in ongoing oncology clinical trials
10
Manufacturing sites for oncology medicines on 3 continents
3
Core therapeutic modalities expand combination treatment opportunities
14
707: Potential Development Opportunities
THORACIC GENITOURINARY
Nsq NSCLC：~104K US patients
Sq NSCLC： ~37K US patients
UC：~19K US patients
RCC: ~16K US patients
ES-SCLC：~33K US patients
GASTROINTESTINAL
Potential to address
350K+
US patients
OTHER CANCERS
CRC：~63K US patients
~80K+ US patients
：Included in 3SBio Phase 1/2 studies in China Source: Pfizer
Nsq: Non-squamous; Sq: Squamous; NSCLC: Non-small cell lung cancer; ES-SCLC: Extensive Stage Small Cell Lung Cancer;
15 UC: Urothelial Carcinoma; RCC: Renal Cell Carcinoma; CRC: Colorectal Cancer
707: Next Generation of IO Therapy, Potential Backbone
99 US$bn
2029Est
50 US$bn
2024
Global revenue of PD-(L)1 Ab surpassed 50 Bn USD in 2024，PD-(L)1 global market size is expected to reach 99 Bn USD in 2029
Opdivo ®
(Nivolumab)
Keytruda®
(Pembrolizumab)
Keytuda and Opdivo approved decades of
indications worldwide, PD-(L)1 therapy has become the backbone of cancer treatment
Approved indications
40+
Approved indications
20+
Imfinzi ®
(Durvalumab)
Tecentriq ®
(Atezolizumab )
Libtayo ®
(Cemiplimab)
Bavencio ®
(Avelumab)
TEVIMBRA ®
(Tislelizumab)
TYVYT®
(Sintilimab)
10+
PD-(L)1 Ab
PD-(L)1 monotherapy for low level of PD-1 expression SCLC/NSCLC，MSS or MSI-L CRC patients etc. has limited responses1
NSCLC SCLC CRC GC HNSCC HCC ESCC BTC RCC OC CC UC STS
PD-1 PD-L1 | 19-20% | 12-19% | <10% | 13-14% | 13-16% | 16-17% | 19-20% | 3-22% | 22% | 8-15% | 14% | 20-29% | 5-18% |
14% | 2-10% | 5% | 10% | 13-24% |
1.5 mn2 1.4+mn
PD-(L)1 uncovering
PD-(L)1 covered
Improve PD-(L)1 efficacy, cover the double scale of population
Frost & Sullivan, Prospectus
BNTX website
16
Retain the Global Rights of Supplying
FDA&EMA GMP standard
01 • Manufacture, examination, storage fully automated intelligent factory
High standard quality system
Manufacturing Base of
02
Large-scale DS and DP
Global Supply
03
75,000L+ biologics DS capacities
6*12,000L stainless steel bioreactors;
3*1000L disposable bioreactors and more manufacturing lines
40 mn+/ year DP capabilities
Completely automatic penicillin vial and prefilled syringe manufacturing lines
17
02 R&D
18
10
IND& Phase I
6
Phase II
R&D Pipeline - 30 Candidates
Therapeutic Area | Candidates | Pre-clinical | IND | Ph I | Ph II | Ph III | NDA | ||
Nephrology | SSS06 Long-acting rhEPO | NDA | |||||||
Remitch-CLD pruritus | |||||||||
SSS17 HIF inhibitor | |||||||||
Hematology and Oncology | TPO 106-CLDT | NDA | |||||||
SSS20 Eltrombopag | ANDA | ||||||||
CS1003 anti-PD1 Ab | |||||||||
602 anti-EGFR Ab | |||||||||
609A anti-PD1 Ab | |||||||||
707 anti-PD1/VEGF BsAb | U.S.IND | ||||||||
705 anti-PD1/HER2 BsAb | |||||||||
706 anti-PD1/PDL1BsAb | |||||||||
708 anti-PD1/TGF-β Ab | |||||||||
SSS40 anti-NGF Ab | |||||||||
SSS59 anti-MUC17/CD3/CD28 TsAb | |||||||||
SPGL008 anti-B7H3 Ab/IL15 FP | |||||||||
SA102 CS1/BCMA CAR-T | |||||||||
SSS41 CAR-T | |||||||||
Autoimmune, Ophthal mology and others | 608 anti-IL17A Ab NDA | ||||||||
601A anti-VEGF Ab | |||||||||
613 anti-IL1β Ab | NDA | ||||||||
611 anti-IL4Rα Ab | U.S.Ph I | ||||||||
610 anti-IL5 Ab | |||||||||
621 anti-IL33 Ab | U.S.IND | ||||||||
SSS11 Pegsiticase | |||||||||
SSS39 Rapamycin Nanoparticle | Antibody | ||||||||
626 anti-BDCA2 Ab | U.S.IND | Others | |||||||
627 anti-TL1A Ab | U.S.IND | ||||||||
Dermatology & Metabolism | WS204 Clascoterone | Small Molecule | |||||||
Semaglutide | |||||||||
Minoxidil Foam-Female AGA | |||||||||
9
Phase III
5
NDA /ANDA
Submission
19 Note：shows the most advanced clinical development stage of each candidates in the chart
Candidates Layout in Tiers
Strong Momentum Support Long-term Growth
Commercialized Product
Hematology/ Oncology
Mandi
Dermatology
/Metabolism
Nephrology
Hematology
/Oncology
Autoimmune
Minoxidil Tincture
EPO
Recombinant Human Erythropoietin Injection
TPIAO
Recombinant Human Thrombopoietin Injection
YSP
Recombinant Human TNF-α Receptor
Ⅱ:IgG Fc Fusion Protein for Injection
Clifutinib DB-1303
Co
SSGJ-707
Development milestone Regulatory milestone
Sales milestone and royalties
Paclitaxel Oral
Solution
mmercialization partners
Nephrology
SSS06
SSS17
Hematology/ Oncology
TPIAO CLDT
Cipterbin Neoadjuvant
Autoimmune
608
613
610
611
Dermatology/Metabolism etc. • Semaglutide
Clascoterone
601A
Late-stage clinical trials
705
706
SSS40
SSS59
SPGL008
SSS41……
Autoimmune
626
627
621
More preclinical candidates
Early-stage clinical trials
20
Hematology & Oncology
Bispecific Antibody
707 anti-PD1/VEGF BsAb | Mono 1L PD-L1+NSCLC | Phase III (BTD) | |||||||
1L NSCLC Combo with Chemo | Phase II | ||||||||
mCRC | Phase II | Exercises the option | |||||||
EC/PROC | Phase II | of China rights | |||||||
705 anti-PD1/Her2 BsAb | |||||||||
HER2+ Advanced Solid Tumors | Phase II | Only actively ongoing clinical trial in China | |||||||
706 anti-PD1/PD-L1 BsAb | Advanced Gastrointestinal Tumors Advanced NSCLC | Phase II Phase II | Only actively ongoing clinical trial in China | ||||||
SPGL008 B7H3 Ab/ IL15 Fusion Protein | Solid Tumors Bladder Cancer | Pre-clinical | Phase I | Global First-In-Class | |||||
Trispecific Antibody | |||||||||
SSS59 MUC17/CD3/CD28 TsAb | Solid Tumors | Phase I | Global first to enter clinical trial First-In-Class | ||||||
Monoclonal Antibody | |||||||||
SSS40 anti-NGF Ab | Cancer Pain with Bone Metastases | Phase II | |||||||
21
705: Anti-PD-1/PD-L1 BsAb for Pan-HER2 Expressing Tumors
705
anti-PD1/HER2 BsAb
705 connects ScFv of anti-PD1 to the heavy chain Fc segment of Trastuzumab through GGGGS, and simultaneouslyinhibits PD-1/PD-L1 signaling pathway and HER2 signaling pathway
Anti-Her2: 3SBio self-developed Cipterbin
Anti-PD-1: 3SBio self-developed human PD-1 ScFv
Combines targeted therapy and immune therapy, expected to achieve more effective tumor immune monitoring
705 mediates the unique T-cell activation activity of the bispecific antibody through PD-1 synapses, achieving multiple tumor cell killing mechanisms
6 0
L y s is %
4 0
2 0
0
- 2 0
A D C C to w a r d s B T 4 7 4 c e l ls
L y s is %
- 3 - 2 - 1 0 1 2
Trastuzumab | 705(anti-HER2×PD1) | |
EC50 | 2.98 | 3.66 |
log n M
7 0 5 ( a n t i- H E R 2 × P D 1 )
T r a s tu z u m a b
705 mediates ADCC effect to selectively kill tumor cells but
not activated T cells;
PD-1 was induced to rearrange on the surface of T cells and form immune clusters between T cells and tumor cells, greatly activated the tumor killing activity of T cells;
705 activated T cells to achieve double-antibody
superposition effect
705 demonstrated significant tumor suppression activity across a variety of tumor models
1 ,0 0 0 ,0 0 0
L u m (R L U )
8 0 0 ,0 0 0
6 0 0 ,0 0 0
0
4 0 0 ,0 0 0
N 8 7 - P D L 1 + P B M C
50nM
10nM
2nM
d a y 4
7 0 5 ( a n t i- H E R 2 × P D 1 )
T ra s tu z u m a b + 6 0 9 A ( a n ti- P D 1 ) T ra s tu z u m a b
6 0 9 A ( a n ti- P D 1 )
N 8 7 - p d L 1 + p b m c N 8 7 - p d L 1
1200
Tumor Volume(mm^3, mean±SEM)
1000
800
600
400
200
0
NCI-N87
0 10 20 30 40
Days post treatment
Human gastric cancer cells
PBS
302 2mpk
302 6mpk
302 20mpk
705 2.66mpk
705 7.98mpk
705 26.6mpk
1200
Tumor Volume(mm^3, mean±SEM)
1000
800
600
400
200
0
Calu-3
0 10 20 30
Days post treatment
Human lung cancer cells
PBS
Herceptin 20mpk
705 1.33mpk
705 6.65mpk
705 26.6mpk
2000
Tumor Volume(mm^3, mean±SEM)
1500
1000
500
0
MC38
0 10 20
Days post treatment
Mouse colorectal cancer cells
PBS
609A 3 mpk
609A 10 mpk
KEYTRUDA 3 mpk KEYTRUDA 10 mpk
705 1.33 mpk
705 3.99 mpk
705 13.3 mpk
22
A D C C to w a r d s T C e lls
6 0
4 0
7 0 5 ( a n t i- H E R 2 × P D 1 )
T r a s tu z u m a b M H C I Ig G 1
2 0
0
- 3
- 2
- 1
0 1
2
log n M
EC50 0.8911
706: Anti-PD-1/PD-L1 BsAb targeting Pan-tumors
Demonstrating chemical and physical properties while preserving the dual-targeting functionality of the bispecific antibody, with distinct synergistic effects of bispecific antibody
706
Excellent physicochemical properties
anti PD-1/PD-L1 BsAb
Achieving synergistic effects through the formation of PD1
synapses
Demonstrates superior PD-1/PD-L1 binding avidity and significantly enhanced bioactivity in stimulating IL-2 and IFN-γ secretion compared to either monotherapy or their combination therapy
Significant tumor suppression and dose-dependent effects in multiple solid tumor models including colorectal, breast and lung cancers
Bispecific antibody developed derived from self-developed CLF2 bispecific antibody platform, simultaneously targeting PD-1 and PD-L1 can effectively avoiding bispecific antibody mispairing and possessing physicochemical properties comparable to monoclonal antibodies.
China IND and US IND，phase I in Chian. Patents applied in multiple countries and regions across China, the US, Europe, and Japan.
Tumor Volume(mm^3, mean±SEM)
Tumor Volume(mm^3, mean±SEM)
2500
PBS
MC38
Tumor Volume(mm^3, mean±SEM)
2000
EMT-6
H292
PBS PBS/PBMC
Opdivo 10mg/kg/PBMC
Tecentriq 10mg/kg/PBMC SSGJ-706 16mg/kg/PBMC
1000
800
600
Tumor Volume(mm^3, mean±SEM)
PBS
2000
1500
1000
500
SSGJ-706 1.6 mg/kg
SSGJ-706 4.8 mg/kg
SSGJ-706 16 mg/kg
1500
1000
500
Opdivo 10mg/kg
αPD-1 10mg/kg SSGJ-706 1.6mg/kg SSGJ-706 4.8mg/kg SSGJ-706 16mg/kg
0
0 3 6 9 12 15 18
Days post treatment
0
0 3 6 9 12 15 18 21 24 27 30
Days post treatment
400
200
0
0 5 10 15 20
Days post treatment
23 hPD1 transgenic mouse MC38 xenograft model
hPD1 mouse EMT-6 xenograft model PBMC mouse NCI-H292 xenograft model
MC38
2500
2000
PBS
609A 10 mg/kg
Keytruda 10 mg/kg
SSGJ-706 16 mg/kg
1500
1000
500
0
0
3 6
9
12 15 18
Days post treatment
SSS59: Anti-MUC17/CD3/CD28 Trispecific Ab for Gastrointestinal Tumors
MUC17 is highly expressed in various Gastrointestinal tumors (including gastric cancer and colorectal cancer), and demonstrate a potentialgastrointestinal tumors-associated target ;
SSS59 represents an enhanced T-cell engager (TCE) that incorporates both primary CD3 activation and secondary CD28 costimulation within a single molecular construct, eliciting sustained anti-tumor T-cell responses;
Compared to the control antibody, this modified antibody exhibits reduced CD3 affinity to prevent cytokine storms, while the enhanced CD28 signaling compensates for the diminished activation resulting from the lower CD3 binding affinity, achieving comparable preclinical efficacy to the control in animal models.;
SSS59 has obtained IND approval and entered Phase I clinical trial.
SSS59
Anti-MUC17/CD3/CD28 trispecific Ab
immunodeficient mice
Tumor Inhibitory Effects on mCRC |
Dose-dependent inhibitory effect of SSS59 on the growth of human colon cancer xenografts in PBMC-reconstituted |
SSS59 Exhibits Molecular Structure Superiority
Superior inhibitory effect on target cell proliferation compared with McAb or BsAb
24
Superior inhibitory effect on target cell proliferation than comparable CODV-IgG trispecific antibody
SPGL008: Anti-B7H3-IL15 Fusion Protein, Targeting Pan-tumor
Combination of IL15 and IL15Rα localizes to specific cell membranes, and binds to the β/γ receptor (CD122 and CD132) shared with IL2, thereby stimulating adjacent effector cells, primarily NK and CD8+ T cells, to mediate biological activity;
Compared to IL2, IL15 plays no effect on Treg cells, which is a key advantage.
SPGL008
B7H3 Ab /IL-15 fusion protein
Mutation
SPGL008 is an IL15 bifunctional molecule targeting tumor via B7H3 (i.e., CD276 ) McAb.
Tumor-targeted single-chain IL15, with antibody mutations to attenuate toxicity, Mitigating the toxicity and limited efficacy associated with IL-15;
IND approval and entered Phase I clinical trials.
JIMT-1 is HER2-antibody-resistant human breast cancer cell line, the combination of SPGL008 with a HER2 MsAb achieved an 83 % tumor growth inhibition rate.
Significant tumor suppressive activity across multiple tumor models
H1975 is a human lung cancer cell expressing B7H3, SPGL00 demonstrated dose-dependent inhibition of tumor cell proliferation across all tested doses.
Highly expressed in multiple solid tumors
25
Nephrology
Biopharmaceuticals
SSS06 Long-acting rhEPO | Renal Anemia with Maintenance Dialysis | NDA Accepted | |
Cancer Related Anemia (CIA) | Phase II | Q3W Once every three weeks | |
Fill the gap in domestic long-acting erythropoietin |
Small Molecule
Phase II data showed efficacy was
accurate
Phase II
Non-dialysis Renal Anemia ( CKD )
Post-orthopedic Surgery Anemia ( POA )
SSS17
HIF Inhibitor
Better compliance for postoperative patients with limited mobility
Phase II
Lower risks of AESI such as thrombosis and hypertension
QW
Once weekly oral
administration
26
SSS17: Optimized Choice for CKD Anemia and POA Patients
HIF inhibitor: Inhibiting PH enzyme activity, blocking degradation effects on hypoxia-inducible factor (HIF), enhancing HIF-α levels, thereby
SSS17 promots the synthesis of key proteins such as erythropoietin (EPO) and threats renal anemia.
91H
The longest half-life, providing a superior dosing regimen among HIF inhibitors
Positive phase II interim data for CKD non-dialysis patients
Developing Post-orthopedic Surgery ( POA ) Indication and enhance overall competitiveness
The change in average Hb at weeks 7-9 from Baseline showed efficacy was accurate. The clinical effects performed non-inferior results relative to Roxadustat.
27
1, Data as of December 27, 2024
Only short-acting therapeutic regimens are available for anemia patients during perioperative period, SSS17 can enhance patient compliance.
SSS17
106.2
89.0 90.6
85.4
Placebo
ΔHb change of SSS17 compared to
Placebo
17.2
22.4
Baseline Hb
WK7-9 Average Hb
(5.2)
WK7-9 Average Hb Change from Baseline ( ΔHHb )
Autoimmune
Establishing the Most Competitive Autoimmune Pipeline
613
anti-IL-1β Ab
611
anti-IL-4R Ab
610
anti-IL-5 Ab
626
anti-BDCA2 Ab
627
anti-TL1A Ab
AG PGF
Adult AD (Monotherapy) | Phase III | |
Adult AD (with TCS) Adolescent AD Pediatric AD CRSwNP COPD | Phase III | |
Phase III | AD full population | |
Phase III | coverage | |
Phase III | ||
Phase III |
Eosinophilic Asthma
SLE CLE
UC
Phase II
NDA Acceptable
Phase III
Ranks NO.1 progress in China
FIC in CHINA FIC in CHINA
Phase I
Phase I
Phase I
28
608
anti-IL-17A Ab
Moderate-to-severe PsO AS
Nr-axSPA
NDA Acceptable
Phase II Completed
Phase II
"Cure" for PSO
608 (anti-IL-17A mAb)
608: Achieving a "Cure" aspiration for PsO treatment | |||||||
Dosing interval extended to Q4W or Q8W in maintenance after 12 weeks: W52: Efficacy of PASI75、sPGA0/1 and PASI90 responses was highly effective and sustained | |||||||
PASI75 | PASI90 | sPGA0/1 | |||||
93.70 % | 93.60 % | 92.60 % | 92.50 % | 89.30 % | 89.40 % | ||
608-A 1 | 608-B | 608-A | 608-B | 608-A | 608-B | ||
ASAS40: the primary efficacy endpoint in the Phase III study. 608 showed robust response, with superior efficacy trend.
608 AS： Ph II shows significant efficacy
% of subjects achieving an ASAS20 response at W16 - FAS
% of subjects achieving an ASAS40 response at W16 - FAS
64.00% 64.00%
58.80%
66%
36.0% 34.0%
47.1%
36.0%
608 A2 608 B 608 C Adalimumab 608 A 608 B 608 C Adalimumab
29 1: 608 A：160 mg W0+80 mg Q2W(first 12weeks)+80 mg Q4W； 608 B：160 mg Q4W (first 12weeks)+160 mg Q8W 2: 608 A：160+80mg Q2W(n=50） 608 B：160mg Q2W(n=50) 608 C：160mg Q4W(n=51） adalimumab （n=50）
% of subjects achieving an ASAS40 response in multiple dose-FAS
50%
40%
608 160mg+80mg Q2W(N=50)
608 160mg Q2W(N=50)
608 160mg Q4W(N=51)
Adalimumab(N=50)
30%
20%
10%
0%
W0 W2 W4
W8
W12
W16
613 (anti-IL-1β mAb)
Acute phase:
both phase III endpoints were achieved
Intermittent phase:
a single dose can effectively prevent acute attacks
-55.6 -54.7
baseline
change from
Shorten the duration of AG
attacks
Delay the onset of the
first AG attack
Reduce proportion of AG
attacks
Reduce AG
arthritis recurrence rate
Primary endpoint 1：72h VAS score change from baseline
72h VAS
score (mm)
613
Compound Betamethasone
Risk reduction
38%
0.62
Risk reduction
39%
0.61
Not reached
Not reached
Not reached
Risk reduction
57%
0.43
Risk reduction
62%
0.38
HR
relative risk of acute gout episodes per capita（RR）
Median time to first acute gou t attack*
Colchicine
0.5 mg
（ N=51 ）
613-200 mg
（ N=52 ）
613-100 mg
（ N=53 ）
Group
Upper limit of 95%CI between the two groups was 2.7mm, less than the preset non-inferiority threshold (10mm), non-inferiority result was supported
-0.8 (-4.4, 2.7)
95%CI
Primary endpoint 2: 12W recurrence period in days
Recurrence period in days (W12) | 613 | Compound Betamethasone |
Mean (days) | Not reached | 57 |
HR(95%CI) | 0.23 (0.17, 0.32) | |
P <0.0001, superiority is established | ||
Duration of gout attack
（days）
1.67
1.35
6.7
30
613: Comprehensive Disease Management for Gouty Arthritis Patients
Enrollment of Phase III Acute Gouty Arthritis (AG) was completed, with positive interimanalysis results
Gouty Arthritis (PGF) Phase II results are positive and pre-PhIII communication is ongoing
Progress ranks No.2 in China
One dose prevents
ecurrence for 3~6 months
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