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Keymed Biosciences Announces 2026 H1 Results and Business Updates

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Keymed Biosciences (HKEX:02162) reported interim results for the six months ended June 30, 2026, highlighting its dual-engine strategy of domestic commercialization and overseas business development. Total revenue reached RMB617 million, driven mainly by core product Kangyueda, whose sales jumped 132% year-on-year to RMB393 million.

Collaboration revenue was RMB224 million, primarily from a milestone payment under Keymed’s exclusive license agreement with AstraZeneca. Profit for the period was RMB1,220 million, swinging from a prior loss, supported by the successful acquisition of NewCo partner Ouro Medicines by Gilead and Lakefront (LKFT) and rapid revenue growth. Keymed held cash reserves of about RMB3.24 billion. The company also received an upfront payment of US$257 million from the CM336 transaction and is eligible for additional milestones and tiered royalties, while multiple late-stage and earlier-stage clinical programs continued to advance globally.

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Positive

  • H1 2026 revenue RMB617 million, mainly driven by Kangyueda commercialization
  • Kangyueda sales RMB393 million, a 132% year-on-year increase in H1 2026
  • Collaboration revenue RMB224 million in H1 2026, largely from an AstraZeneca milestone
  • Profit for the period RMB1,220 million, reversing from a prior loss
  • Cash reserves about RMB3.24 billion, supporting ongoing R&D and commercialization
  • US$257 million upfront payment from the CM336 transaction, plus eligibility for up to US$70 million in additional milestones and up to US$610 million under the existing license, with tiered royalties

Negative

  • None.

News Explained

Kangyueda gains a nationwide public-hospital procurement pathway, while CM336 development and overseas rights are now split between Lakefront and Gilead.

Keymed reports that Kangyueda was officially included in the National Essential Medicines List in July, with the inclusion taking effect on September 1, 2026; public medical institutions are required to procure and prioritize listed medicines, creating a stated nationwide procurement pathway for the product.

The Ouro transaction is described as officially completed on June 5, 2026, with Lakefront acquiring substantially all of Ouro’s team and operating assets. Lakefront is responsible for ongoing and future Phase I/II studies, and Gilead will lead pivotal and late-stage studies; Gilead solely owns commercialisation rights outside Greater China.

For CM336, the next stated development checkpoint is initiation of the Phase III combination study after clinical-trial approval; the IND application was accepted on July 3, 2026.

Market Context

A prior Ouro Medicines acquisition headline recorded -0.32% over 24 hours, providing the platform's ...
Analysis

A prior Ouro Medicines acquisition headline recorded -0.32% over 24 hours, providing the platform's closest comparison. The current results combine commercialization and partnering data; milestone timing and clinical execution remain risks to monitor.

Key Figures

Total revenue: RMB617 million Kangyueda revenue: RMB393 million; +132% Collaboration revenue: RMB224 million +5 more
8 metrics
Total revenue RMB617 million First half of 2026
Kangyueda revenue RMB393 million; +132% First half of 2026, year-on-year increase
Collaboration revenue RMB224 million Six months ended June 30, 2026
Profit for the period RMB1,220 million First half of 2026
Cash reserves RMB3.24 billion As of June 30, 2026
Upfront payment US$257 million CM336 license agreement and Ouro transaction
Milestone payments Up to approximately US$70 million CM336 transaction-related entitlement
Additional milestone payments Up to US$610 million To be fulfilled by Gilead and Lakefront

Historical Context

1 past event · Latest: Jun 04 (Positive)
Pattern 1 events
Date Event Sentiment 24h Move Catalyst
Jun 04 acquisition completion Positive -0.3% Ouro acquisition added gamgertamig to Lakefront's pipeline; shares declined 0.32% over 24 hours.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The comparable acquisition-related announcement was followed by a negative 24-hour reaction despite the transaction's reported strategic benefits.

Key Terms

out-licensing, milestone payment, phase iii clinical study, fast track designation, +2 more
6 terms
out-licensing financial
"Overseas out-licensing collaborations in respect of its key pipelines"
Out-licensing is when a company grants another firm the right to develop, manufacture or sell a product or technology in exchange for upfront payments, milestone fees and ongoing royalties. Think of it like leasing a recipe to a larger kitchen so they handle production and sales while the original owner collects steady income and reduces costs and risk. For investors, out-licensing can speed commercialization, create near-term revenue, lower development expenses, and shift where future profits and growth will come from.
milestone payment financial
"The Group has received an upfront payment of US$257 million, and is entitled"
A milestone payment is a pre-agreed cash amount paid when a company reaches a specific, measurable achievement in a partnership, such as completing a clinical trial stage, receiving regulatory approval, or hitting a sales target. For investors it signals how future revenue and risk are shared — like progress payments on a construction project, these payments can unlock value and affect a company’s cash flow and valuation as each milestone is met.
phase iii clinical study medical
"advancing a randomized, double-blind, placebo-controlled Phase III clinical study"
A phase III clinical study is a large, late-stage trial that tests whether a drug or medical treatment works and is safe in a broad group of patients, often by comparing it to standard care or a placebo. Think of it as the final dress rehearsal before regulators decide on approval; successful results can unlock commercial sales, while failures can stop a product from reaching the market, affecting a company’s revenue prospects and valuation.
fast track designation regulatory
"has obtained Fast Track Designation and Orphan Drug Designation from the FDA"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
breakthrough therapy designation regulatory
"as well as Breakthrough Therapy Designation from the CDE"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
cgmp regulatory
"All such designs comply with the cGMP requirements of the NMPA and the FDA"
cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

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CHENGDU, China, Aug. 20, 2026 /PRNewswire/ -- On August 19, 2026, Keymed Biosciences (HKEX: 02162) announced 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.

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.

Cision View original content:https://www.prnewswire.com/news-releases/keymed-biosciences-announces-2026-h1-results-and-business-updates-302856519.html

SOURCE Keymed Biosciences

FAQ

How did Keymed Biosciences perform in its 2026 H1 financial results?

Keymed reported H1 2026 revenue of RMB617 million and profit of RMB1,220 million. According to Keymed, growth was driven by Kangyueda commercialization, collaboration revenue of RMB224 million, and the impact of the Ouro Medicines transaction with Gilead and Lakefront (LKFT).

What drove the profit swing for Keymed in the first half of 2026?

Keymed recorded RMB1,220 million profit in H1 2026, swinging from a loss. According to Keymed, this was mainly due to the successful merger and acquisition of its NewCo by a multinational company, rapid revenue growth, and improved operational efficiency during the reporting period.

How much revenue did Kangyueda contribute to Keymed in 2026 H1?

Kangyueda generated RMB393 million in sales revenue in H1 2026, up 132% year-on-year. According to Keymed, inclusion in China’s medical insurance and later the National Essential Medicines List is expected to support broader hospital coverage and deeper market penetration across more cities and healthcare levels.

What is the significance of the CM336 transaction with Gilead and Lakefront (LKFT) for Keymed?

Keymed received an upfront payment of US$257 million from the CM336 transaction and may receive up to about US$70 million more. According to Keymed, Gilead and Lakefront will also fulfill up to US$610 million in license milestones plus tiered royalties on future net sales.

How strong is Keymed Biosciences’ cash position after its 2026 H1 results?

Keymed reported cash reserves of about RMB3.24 billion as of June 30, 2026. According to Keymed, this figure includes cash and cash equivalents, time deposits, and financial assets at fair value through profit or loss, supporting sustained R&D investment and global commercialization activities.

Which late-stage pipeline assets did Keymed highlight in its 2026 H1 update?

Keymed highlighted Kangyueda, Stapokibart and CM512 among late-stage assets in H1 2026. According to Keymed, CM512 met all Phase II endpoints in chronic rhinosinusitis with nasal polyps and rapidly entered Phase III, while Stapokibart is in multiple Phase III studies for dermatologic and respiratory indications.

How is Keymed advancing its dual-engine strategy of commercialization and business development?

Keymed’s dual-engine strategy combines domestic sales of Kangyueda with overseas business development revenue. According to Keymed, this includes a nearly 500-person commercialization team in China and global out-licensing deals, such as AstraZeneca and the CM336 collaboration involving Gilead and Lakefront (LKFT).