On August 20, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology company that identifies differentiated innovation and applies disciplined development, financing, and partnering strategies to create value, reported financial results for the six months ended June 30, 2026, and provided a business update. During the first half of 2026, the Company continued executing its strategic priorities by progressing key clinical milestones for its lead programs. The Company also strengthened leadership, governance, and capital allocation to support long-term value creation.

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"Significant innovation exists across geographies and organizations, yet many promising therapies never reach their full potential," said Srishti Gupta, MD, MPP, Chief Executive Officer of NovaBridge. "NovaBridge was built to identify those opportunities, advance them efficiently and create value through the path best suited to each asset. The progress of givastomig and VIS-101 reflects our ability to both identify differentiated science and to achieve meaningful development milestones, positioning NovaBridge to continue creating value for patients and shareholders."

"NovaBridge is building the capabilities required to succeed over the long term. The progress of givastomig and VIS-101, together with the continued strengthening of the organization, reflects deliberate execution against that objective," said Fu Wei, Chairman of the Board of NovaBridge.

Pipeline Overview and Potential Upcoming Milestones

NovaBridge’s two lead programs illustrate the complementary capabilities at the core of its strategy. Givastomig, a potential first-in-class Claudin 18.2-Targeted Immuno Amplifier ("CTIA"), reflects NovaBridge’s ability to efficiently execute differentiated science toward registrational development. VIS-101, a purpose-designed tetravalent VEGF-A × ANG-2 peptibody for retinal vascular diseases, developed through NovaBridge’s majority-owned subsidiary leading its ophthalmology platform, Visara, Inc. ("Visara"), reflects NovaBridge’s ability to identify and acquire differentiated therapeutic assets that others have overlooked.

Givastomig

Givastomig is a potential first-in-class CTIA. It is a bispecific Claudin 18.2 × 4-1BB antibody targeting Claudin 18.2-positive tumor cells being developed for the treatment of first-line metastatic gastric cancer.

In January 2026, NovaBridge reported positive data from the givastomig Phase 1b dose expansion combination study in patients with first-line ("1L") gastric cancer. The data showed that givastomig produced a 77% ORR at 8 mg/kg and 73% ORR at 12 mg/kg (among 52 evaluable subjects), and a 16.9-month median progression-free survival at 8 mg/kg (among 27 evaluable subjects), with responses observed across a range of PD-L1 and Claudin 18.2 expression levels. Givastomig demonstrated favorable overall tolerability in combination with immunochemotherapy without dose-dependent toxicity.

In February 2026, NovaBridge initiated a global, randomized Phase 2 study of givastomig combined with immunochemotherapy in patients with HER2-negative, 1L metastatic gastric cancer.

In March 2026, NovaBridge reported givastomig’s potential eligibility for the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Pathway in first-line HER2-negative, Claudin 18.2-positive, PD-L1-positive patients with gastroesophageal adenocarcinoma ("GEA").

In June 2026, the FDA granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic GEA in combination with nivolumab and chemotherapy.

NovaBridge estimates that approximately 180,0001 patients are diagnosed with first-line GEA in the U.S., France, Germany, Italy, Spain, the United Kingdom and Japan, of which approximately 105,0002,3 cases are HER2-negative and Claudin 18.2-positive, the population givastomig targets. The Company also believes givastomig has broad potential across other Claudin 18.2-positive gastrointestinal malignancies, including biliary tract cancer and pancreatic ductal adenocarcinoma.

Upcoming Givastomig Milestones:

•
October 25, 2026: Poster presentation of Phase 1b combination dose expansion data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026
•
As early as YE 2026: Initiate Phase 3 registrational study under a potential Accelerated Approval Pathway
VIS-101

VIS-101 is a potential best-in-class VEGF-A × ANG-2. It is a purpose-designed tetravalent peptibody being developed for neovascular retinal diseases. Positive Phase 2a data reported in March 2026 demonstrated favorable safety and tolerability results, meaningful visual acuity improvements, and encouraging durability in neovascular (wet) age-related macular degeneration ("nAMD") patients. VIS-101 is being developed for nAMD, diabetic macular edema ("DME"), and retinal vein occlusion ("RVO"), which together affect more than 57 million people globally.4

VIS-101 is being advanced through Visara. Consistent with NovaBridge’s operating model, Visara combines specialized ophthalmology expertise with NovaBridge’s strategic oversight, capital allocation, and business development capabilities to support focused execution and future growth of the ophthalmology franchise.

Upcoming VIS-101 Milestones:

•
H2 2026: Initiate Phase 2b program in nAMD
•
2027: Initiate global Phase 3 program in nAMD
1H Execution Highlights

During the first half of 2026 and subsequent period, NovaBridge continued to strengthen its leadership team to support the Company’s next phase of growth. NovaBridge appointed Srishti Gupta, MD, MPP, as Chief Executive Officer to lead corporate strategy, capital allocation, business development, and operational execution. The Company also appointed Mark Hagler as Chief Commercial Officer, adding commercial and portfolio planning expertise to support future development and partnership opportunities. At Visara, Jeffrey Nau, PhD, MMS, was appointed President and Chief Executive Officer to lead the advancement of VIS-101 and the continued build-out of the ophthalmology franchise. With these additions, NovaBridge continued executing its strategy to identify, develop, and create value from differentiated therapeutic assets. During the period, the Company advanced key pipeline programs toward important development milestones while continuing to evaluate opportunities to expand its portfolio and create long-term value for patients and shareholders.

In addition, NovaBridge is implementing enhancements to its segment disclosure and half-year reporting structure, expected to provide shareholders with clearer visibility into the performance of the Company and its operating subsidiaries.

First Half 2026 Financial Results

Cash Position

As of June 30, 2026, the Company had cash, cash equivalents, short-term investments, and equity investment at fair value of $215.9 million. Based on its current operating plan, the Company believes its cash position is sufficient to support the advancement of its portfolio through multiple anticipated clinical and strategic milestones, including givastomig’s planned Phase 3 interim data read-out in 2028.

Research & Development Expenses

Research and development expenses were $14.3 million for the six months ended June 30, 2026, compared to $4.1 million for the six months ended June 30, 2025. The increase was primarily driven by investment in clinical development activities for givastomig and the continued build-out of NovaBridge’s development capabilities to support current and future portfolio programs.

Administrative Expenses

Administrative expenses were $26.4 million for the six months ended June 30, 2026, compared to $8.3 million for the six months ended June 30, 2025. The increase was primarily driven by higher share-based compensation expense associated with equity awards granted in 2025, increased personnel-related costs as the Company expanded its organizational capabilities, and a one-time write-off of deferred offering costs related to the previously proposed HKEx dual primary listing.

Net Loss

Net loss was $37.9 million for the six months ended June 30, 2026, compared to $8.7 million for the prior-year period. Net loss per share attributable to ordinary shareholders was $0.14 compared to $0.05 in the prior-year period.

About Givastomig

Givastomig (TJ033721 / ABL111), a potential first-in-class CTIA, is a Claudin 18.2 × 4-1BB bispecific antibody. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2+ gastrointestinal malignancies including biliary tract cancer and pancreatic ductal adenocarcinoma. Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b, multicenter, open-label study in first-line gastric cancer. NovaBridge expects to initiate a Phase 3 registrational study under a potential Accelerated Approval Pathway as early as year end 2026.

Givastomig is being jointly developed through a global partnership with ABL Bio, Inc. ("ABL Bio"). NovaBridge is the lead party and shares worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

About VIS-101

VIS-101 (ASKG712/AM712) is a tetravalent VEGF-A × ANG-2 peptibody purpose-designed to be best-in-class. It targets retinal vascular diseases, including nAMD, DME, and RVO, which together affect more than 57 million people globally.⁴ VIS-101 is the only intravitreal therapeutic with two binding sites for each of VEGF-A and ANG-2, and carries the molecular weight of a full-length monoclonal antibody, a structural design intended to deliver a rapid, robust, and durable treatment response for patients with neovascular retinal diseases.

VIS-101 has completed initial safety and dose-escalation studies in both the U.S. and China, along with a randomized, dose-ranging Phase 2a study in China (NCT05456828). It is expected to advance to a randomized, controlled, dose-determining Phase 2b study in the second half of 2026, with anticipated initiation of a global Phase 3 program in 2027.

NovaBridge is the majority shareholder of Visara, which controls global rights to VIS-101 outside of Greater China and certain countries in Asia.

References:

1.
Markets include U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan in 2025 based on Data Monitor Biomed Tracker, based on 1L treatment
2.
HER2-negative status of 78%. Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER-2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer 2015;18(3):476-84
3.
CLDN18.2 positive status of ~70%. Kohei Shitara, et al, 2023 ASCO (Free ASCO Whitepaper) Annual Meeting (June 2-6), poster #4035
4.
Invest Ophthalmol Vis Sci. 2021 Nov 24; 62 (14): 26. doi: 10.1167/iovs.62.14.26
Webcast/Conference Call Details:

NovaBridge will hold a webcast on Thursday, August 20, 2026 at 9:00 AM ET/9:00 PM China Standard Time to discuss recent corporate progress and financial results for the six months ended June 30, 2026.

Webcast Information:

·
Date: Thursday, August 20, 2026
·
Time: 9:00 AM ET/9:00 PM China Standard Time
·
Web Access – China: Click here
·
Webcast Access – All other locations: Click here
The live and archived webcast can also be accessed by visiting the NovaBridge Biosciences website on the Upcoming Events section of the Investors page. A replay of the webcast will be archived for at least 30 days after the event.

(Press release, NovaBridge Biosciences, AUG 20, 2026, View Source [SID1234670251])

On August 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,697,377 B2, entitled "Therapeutic anticancer neoepitope vaccine" related to its individualized neoantigen therapy pipeline candidate, VB10.NEO.

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The newly issued patent relates to Nykode’s fully individualized neoantigen based cancer vaccine, VB10.NEO but also to similar modular neoantigen based cancer vaccines comprising alternative targeting units and/or dimerization units. The 20 year expiration date of this patent is January 5, 2037.

Michael Engsig, CEO of Nykode, said: "This new patent broadens the intellectual property protecting VB10.NEO and our wider neoantigen platform, and it arrives at a pivotal moment for the field. Merck and Moderna’s positive Phase 3 INTerpath-001 data is an important clinical validation of individualized neoantigen cancer vaccines. The question now moves from whether the modality works to which asset can be delivered reliably, and economically, across many indications. With a differentiated APC-targeted design, a neoantigen selection algorithm validated in patients, and an established attractive manufacturing supply chain, we believe VB10.NEO is well positioned to move into a larger set of indications."

Nykode presented data on the VB10.NEO program at the Neoantigen Summit in Amsterdam on July 22, 2026. Further details are available in the Company’s press releases: View Source

Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types.

(Press release, Nykode Therapeutics, AUG 20, 2026, View Source [SID1234670252])

On August 20, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company") reported data from two scientific posters presented at the 2026 Society for Neuro-Oncology/American Society of Clinical Oncology (SNO/ASCO) CNS Metastases Conference, held August 13–15 in Boston. One presentation featured updated pharmacokinetic (PK), pharmacodynamic (PD), dosimetry, safety and activity data for REYOBIQ (rhenium-186 obisbemeda) in patients with leptomeningeal metastases (LM), including emerging safety data from the ongoing repeated-dosing program. The second was an update of a previously reported health economics analysis evaluating the impact of CNSide-enabled earlier LM detection and therapeutic management.

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"The data presented at SNO/ASCO underscore the rationale behind Cerenome’s integrated approach to leptomeningeal metastases – from earlier and more definitive detection and quantitative disease monitoring with CNSide, to targeted local therapy with REYOBIQ," said Marc H. Hedrick, M.D., Cerenome President and Chief Executive Officer. "The REYOBIQ findings provide additional support for broad CSF distribution, limited systemic exposure in most patients, and the continued evaluation of repeat dosing. The CNSide analysis reinforces the potential economic value of earlier, information-rich disease management. Together, these data demonstrate the potential of connecting diagnostics, therapeutics and longitudinal data to improve the management of CNS cancers."

As previously announced, both posters will be available on the Publications page of Cerenome’s website following the conclusion of the conference.

REYOBIQ ReSPECT-LM and ReSPECT-LMM Data

A poster titled, "ReSPECT-LM: Pharmacokinetic and Pharmacodynamic Assessment of Rhenium Obisbemeda in Leptomeningeal Metastases with Emerging Data from Repeated Dosing (ReSPECT-LMM)" was presented by Andrew Brenner, M.D., Ph.D., of The University of Texas Health Science Center at San Antonio. The analysis included updated safety, activity, PK and dosimetry findings from the single-administration study, along with emerging data from the ongoing repeated-dosing program.

Key findings included:

In the ongoing repeated-dosing ReSPECT-LMM study, Cohort 1a cleared with no dose-limiting toxicities, with enrollment ongoing in additional cohorts.
PK showed rapid ( ̴24 hours) redistribution of drug within the CSF with clearance of the REYOBIQ from the lateral ventricle at a half-life of 1.7 hours. By clearing the ventricles quickly, drug remains available at high doses in the cerebral spinal fluid.
Bulk RNA-Seq demonstrated rapid ( ̴5 hours) induction of cell-death (apoptosis) genes, with peak activity occurring at 24 hours. Data promoting cell-death supports REYOBIQ’s established radiopharmaceutical mechanism of action and highlights its rapid onset target activity.
CNSide Cost-of-Care Analysis

The second poster, titled, "Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide: A Cost-of-Care Analysis," was presented by Kelly Kreitzburg Ondrasek, Ph.D., Medical Science Liaison at CNSide Diagnostics. The analysis evaluated the potential economic and clinical impact of a CNSide-enabled care pathway incorporating earlier definitive LM diagnosis, targeted treatment, and quantitative disease monitoring.

The model estimated average LM-related treatment costs of approximately $119,550 per month, or approximately $717,300 over six months. Under modeled scenarios incorporating earlier LM confirmation and optimized management, a CNSide-enabled pathway was estimated to reduce monthly LM-related costs by approximately 33-47%.

(Press release, Cerenome, AUG 20, 2026, View Source [SID1234670254])

On August 20, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported a strategic Option and Research License Agreement (the Option Agreement) and a related equity investment agreement (the Investment Agreement) with IntraGel Therapeutics, Ltd. (IntraGel).

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The Option Agreement includes two strategic components. First, UroGen gains access to IntraGel’s proprietary SRGel platform, a biodegradable, sustained-release formulation technology designed for localized drug delivery, through a research license and options to obtain an exclusive, worldwide license to develop and commercialize up to three additional oncology products combining the SRGel platform with compounds to be designated by UroGen. Second, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure, IntraGel’s investigational therapy for advanced head and neck cancer, following IntraGel’s completion of a Phase 2 clinical study.

"This Option Agreement represents an important step in expanding UroGen’s oncology pipeline and technological capabilities," said Liz Barrett, President and Chief Executive Officer of UroGen. "IntraGel’s biodegradable, sustained-release technology complements our expertise in local drug delivery while creating significant optionality for future innovation. Beyond the opportunity to advance TumoCure following a Phase 2 clinical study, we believe the SRGel technology could potentially enable multiple therapeutic approaches across a range of solid tumors and provide a foundation for new product opportunities over time."

In connection with the Option Agreement, UroGen has also entered into an Investment Agreement with IntraGel, pursuant to which UroGen will invest up to $7 million in the equity securities of IntraGel.

SRGel is a biodegradable depot technology designed to enable sustained local release of therapeutic agents over extended periods. The platform’s flexibility supports multiple therapeutic modalities and has potential applicability across a broad range of solid tumor settings.

"UroGen’s leadership in localized oncology therapies and commercial-stage experience make them an ideal partner to help advance the SRGel platform and accelerate the development of TumoCure," said Peter Siman, Ph.D., Chief Executive Officer and Co-Founder of IntraGel. "We see in this collaboration an important validation of the SRGel platform and the clinical potential of our lead product candidate, TumoCure, while creating a strong pathway to accelerate development across multiple oncology indications."

TumoCure is an investigational cisplatin treatment formulated with IntraGel’s proprietary SRGel platform, designed to enable prolonged localized drug exposure while limiting systemic exposure.

Presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, early clinical data (N=8) showed that TumoCure was generally well tolerated in Phase 1b patients, showed low systemic cisplatin exposure, and provided early indications of anti-tumor activity in a heavily pretreated patient population, including patients with cisplatin treatment-resistant disease. Investigators also reported improvements in tumor-related symptoms in certain patients. These findings support continued clinical development of TumoCure and further expansion of the SRGel platform as a potential approach for sustained local therapy across additional solid tumors with the goal of minimizing systemic exposure.

About SRGel

SRGel is IntraGel’s proprietary injectable hydrophobic gel-like drug delivery platform designed to enable sustained drug release directly within solid tumors. Built on a proprietary water-free and solvent-free fatty-acids based polymer matrix, SRGel is engineered to provide controlled, and prolonged release of therapeutic agents following a single administration, with applicability for both localized delivery at the target site and sustained local exposure.

The technology is designed, when injected intratumorally, to maintain high local drug concentrations while minimizing systemic exposure and associated toxicities. SRGel has shown early indications of compatibility with a broad range of therapeutic modalities, including small molecules, peptides and biologics, and may be applicable across various therapeutic areas and indications, including weight loss management and inflammatory diseases.

About TumoCure

TumoCure is IntraGel’s lead product candidate and the first clinical application of the SRGel platform. TumoCure consists of cisplatin incorporated into the SRGel biodegradable matrix and is administered as a single intratumoral injection. The investigational therapy is designed to provide sustained delivery of cisplatin directly within tumor tissue over several months while limiting systemic exposure.

TumoCure is Phase 2-ready and is currently being developed for patients with locally advanced, inoperable head and neck cancers, who are ineligible for systemic cisplatin-based chemoradiation. IntraGel is pursuing development through the U.S. Federal Drug Administration (FDA)’s 505(b)(2) regulatory pathway and believes the technology may have future applicability across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers.

(Press release, UroGen Pharma, AUG 20, 2026, View Source [SID1234670255])

On August 20, 2026 Keymed Biosciences (HKEX: 02162) reported its interim results for the six months ended June 30, 2026. Guided by a clear dual-engine driven strategy, the company demonstrated outstanding execution capabilities: In the domestic market, following the successful commercialization and implementation of medical insurance coverage for the core product Kangyueda, the company’s highly qualified in-house marketing team rapidly stepped up its efforts, driving a robust breakthrough in domestic commercialization revenue from "1 to N", and providing the Company with a robust cash flow and a solid performance foundation. In the overseas market, the research and development capabilities of Keymed continued to be recognized by multinational pharmaceutical companies. Overseas out-licensing collaborations in respect of its key pipelines and their steady clinical advancement not only validated the Company’s innovative capabilities, but also generated substantial upfront payments and milestone revenue. The steady increase in domestic sales and the continued advancement of overseas (BD) activities complemented each other, establishing a dual-engine driven growth model with exceptional resilience and explosive growth potential.

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Rapid Growth in Sales Revenue, and Cash Flows Contribution from Business Development

In the first half of 2026, the company achieved total revenue of RMB617 million, mainly boosted by the strong performance of our commercialization product, Kangyueda’s revenue increased by 132% to RMB393 million. Collaboration revenue amounted to RMB224 million for the six months ended June 30, 2026, primarily attributable to the milestone payment received under the exclusive license agreement with AstraZeneca AB, attesting to the robust potential of our pipeline. Profit for the period reached RMB1,220 million. The swing from loss to profit was primarily driven by the successful merger and acquisition of our NewCo by MNC and rapid revenue growth, alongside enhancement in operational efficiency. The Company’s cash reserves (including cash and cash equivalents, time deposits, and financial assets at FVTPL) amounted to approximately RMB3.24 billion, providing a solid financial foundation for its sustainable growth and global innovation.

Dual-wheel Drive Fully Launched, Pipeline Portfolio Gaining Momentum

In 2026, Kangyueda entered the first year of full-scale volume growth under medical insurance coverage. As of June 30, 2026, the Company’s commercialisation team comprised nearly 500 personnel, covering more than 1,600 hospitals and over 260 cities, with market access initiatives progressing rapidly. Kangyueda generated sales revenue of RMB393 million, representing a year-on-year increase of 132%. In July 2026, Kangyueda was officially included in the National Essential Medicines List (2026 Edition), which took effect on September 1, 2026. Pursuant to the relevant administrative requirements for essential medicines, public medical institutions at all levels nationwide are required to procure and give priority to the use of medicines included in the list. Such inclusion is conducive to enabling Kangyueda to overcome its previous limitations in Grade III Class A hospitals, accelerating its penetration into county-level and primary healthcare markets, broadening terminal prescription settings and further enhancing the accessibility of the medicine.

In January and March 2026, the marketing applications for Stapokibart for the treatment of moderate-to-severe AD in adolescents and prurigo nodularis (PN) were accepted by the NMPA. Concurrently, we are advancing a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in pediatric subjects with moderate-to-severe AD. As of the date of this announcement, patient enrollment is ongoing. In July 2026, we initiated a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection with background therapy for the treatment of adolescent patients with SAR.

BD Milestone Realization Drives Further Acceleration of Global R&D

CM336 (BCMA x CD3 bispecific antibody): On June 5, 2026, the Group’s NewCo partner, Ouro Medicines, was successfully acquired by Gilead and Lakefront (Euronext & Nasdaq: LKFT, formerly known as Galapagos), and the transaction has been officially completed. The Group has received an upfront payment of US$257 million, and is entitled to receive milestone payments of up to approximately US$70 million. In addition, the exclusive license agreement entered into between the Group and Ouro Medicines in November 2024 remains in effect. The milestone payments of up to US$610 million will be fulfilled by Gilead and Lakefront, and the tiered royalties on net sales ranging from high single digits to mid-double digits will be fulfilled by Gilead. Through this transaction, Lakefront acquired substantially all of the team and operating assets of Ouro Medicines, and will collaborate with Gilead on the subsequent development of CM336/OM336. Lakefront will be responsible for the ongoing and future Phase I/II clinical studies of CM336/OM336, while Gilead will lead the pivotal registrational and late-stage studies. The exclusive global commercialisation rights (excluding the Greater China region) are solely owned by Gilead.
CMG901/AZD0901 (Claudin 18.2 ADC): The CLDN18.2 ADC, in collaboration with AstraZeneca, is leading the global clinical development timeline among the first tier. CMG901/AZD0901 has obtained Fast Track Designation and Orphan Drug Designation from the FDA for second-line or later gastric cancer as well as Breakthrough Therapy Designation from the CDE, with OS demonstrating a statistically significant and highly clinically meaningful benefit (CLDN18.2 expression rate ≥25% for enrolled subjects). The global multi-center Phase III clinical trial for first-line gastric cancer completed its first patient enrollment in early 2026, and the perioperative gastric cancer study is in the Phase II clinical stage. The development is further differentiated by expanding into additional tumor types, including biliary tract cancer and pancreatic cancer.
CM355/PRO-203 (CD20 x CD3 bispecific antibody): Prolium continues to advance an international multi-center Phase I/II clinical study of CM355/PRO-203 for SSc, and completed the dosing of the first patient with systemic sclerosis in June 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026.
Intensive Pipeline Breakthroughs, Next-generation blockbuster lead a new iteration

CM512 (a TSLP/IL-13 bispecific antibody): Next-generation blockbuster CM512 is poised to succeed Kangyueda and lead a new iteration of autoimmune disease treatment. As the world’s first IgG-like long-acting dual TSLP/IL-13 inhibitor, CM512 has a half-life of up to 70 days, has met all clinical endpoints in the Phase II clinical trial for CRSwNP. CM512 demonstrates a rapid onset of action, capable of rapidly shrinking nasal polyps at week 4 post-dosing while significantly improving nasal congestion and promoting the recovery of olfactory function. The efficacy of a single injection can be maintained for six months. At week 24, its change from baseline in the Nasal Polyp Score (NPS) was significantly superior to that of the control group, while overall inflammation of the sinus cavity was significantly reduced, and its Phase III clinical trial has been rapidly initiated. The Company has also established a presence in indications including moderate-to-severe asthma, moderate-to-severe COPD, moderate-to-severe AD in adults, perennial allergic rhinitis, and chronic spontaneous urticaria.
CM336 (BCMA x CD3 bispecific antibody): In the field of autoimmune diseases, we continued to advance an open-label, multi-center Phase II clinical study to evaluate the efficacy and safety of CM336 injection for the treatment of relapsed or refractory primary light-chain amyloidosis in the first half of 2026, and this study is currently in the patient enrollment phase. In May 2026, CM336, intended for the treatment of relapsed or refractory light-chain amyloidosis in patients previously treated with bortezomib and CD38 monoclonal antibody (mAb), was included in the Breakthrough Therapy Designation list.
In the first half of 2026, we continued to advance a Phase I/II clinical study to evaluate the safety and efficacy of CM336 injection for the treatment of subjects with relapsed or refractory autoimmune cytopenias. As of the date of this announcement, patient enrollment for Phase I of the clinical study has been completed. In July 2026, an open-label Phase Ib study was initiated to evaluate CM336 injection in patients with active Sjögren’s syndrome.

In the field of oncology, the IND application for the Phase III clinical trial of CM336 in combination with CM313 (a CD38 mAb) for second-line or later-line RRMM was accepted by the National Medical Products Administration (the "NMPA") on July 3, 2026. The study is divided into two parts: Part 1 is a non-randomized safety run-in phase, and Part 2 is a randomized controlled registration cohort, which will evaluate multiple dosing regimens compared to SOC. The trial will be initiated upon receipt of the clinical trial approval.

Other Pipeline Programs Progressing Steadily:
CM313: Continued to advance a randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the safety and efficacy of CM313 (SC) injection in subjects with IgA nephropathy. As of the date of this announcement, this study is in the patient enrollment phase.

CM518D1: Continued to advance a multi-center, open-label Phase I/II clinical trial.

To date, the Company has submitted Investigational New Drug (IND) applications for multiple pipeline candidates, including CM529D1 (a DLL3/SEZ6 bispecific ADC) for small cell lung cancer, CM583 (a long-acting CGRP/PACAP bispecific antibody) for migraine, and CM551 (a long-acting TL1A/IL-23 p19 bispecific antibody) for inflammatory bowel disease.

We expect that multiple First-in-Class pipeline candidates will enter the IND and clinical stages, including long-acting bispecific antibodies, bispecific ADCs, siRNA and Protac, to address global unmet medical needs in chronic diseases and oncology.

Sustained Momentum in R&D, Production, and Talent Solidifies the Foundation

We have built 6 fully-integrated platforms to enable our in-depth R&D in the areas of immunology and oncology including: Antibody Discovery Platform, KeyMedSTAR ADC Platform, TCE Bispecific Antibody Platform, VESIR Oligonucleotide Platform, Small Molecule Platform and KeyCND Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Our platforms are integrated seamlessly to support key drug development functionalities, including antibody screening, small molecule lead compound discovery, antibody conjugation, functional evaluation, in vivo preclinical studies and biomarker identification. We have the expertise and capability to independently complete the entire drug development process from drug discovery to preclinical research to clinical development and to NDA/BLA application.

To ensure production and supply of high-quality and affordable antibody drugs, we have always been committed to enhancing our in-house manufacturing capabilities. We have internally developed high-expressing cell lines to ensure high yield and low costs for our antibody drugs manufacturing. As of the date of this announcement, the production base in Chengdu has 3 pilot production lines and 3 commercial production lines, with a total production capacity of 21,800 litres. The stainless steel production lines with an additional production capacity of 24,000 litres have completed installation and commissioning and will soon be put into use. All such designs comply with the cGMP requirements of the NMPA and the FDA.

As of June 30, 2026, we had 1,768 full-time employees in total, including nearly 500 employees engaging in commercialization and nearly 420 employees engaged in drug discovery and clinical operations. We will continue to recruit talent to meet the growing needs of commercial sales of products, research and development, clinical, production and the Company’s operations.

Standing at the brand-new starting point of its tenth anniversary, Keymed will continue to uphold its "patient-centric" original aspiration. Leveraging the robust momentum of its dual-drive strategy, the Company will accelerate the research and development and commercialisation process of its global pipeline, committing to providing more high-quality and accessible innovative therapies for patients worldwide, and creating long-term, sustainable, and exceptional value for Shareholders.

(Press release, Keymed Biosciences, AUG 20, 2026, View Source [SID1234670256])