On August 19, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA) (Press release, Mabwell Biotech, AUG 19, 2025, View Source [SID1234655378]). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

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7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell’s proprietary IDDC platform. Its highly optimized structure integrates three key elements:

Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.
Novel cleavable linker: Ensures precise payload release in tumor tissues.
MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.
In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911’s tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:

Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.
Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).
MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.
Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.
Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.
With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. IND application of 7MW4911 has been accepted by China’s National Medical Products Administration (NMPA).

About CDH17

CDH17 is a pan-cancer validated target with restricted expression in normal intestinal epithelium but marked overexpression in gastrointestinal cancers (e.g., colorectal, gastric, pancreatic). Its aberrant expression correlates with tumor metastasis and poor prognosis, positioning it as an ideal therapeutic target.

On August 19, 2025 AbbVie (NYSE: ABBV) reported that it has completed its acquisition of Capstan Therapeutics (Press release, AbbVie, AUG 19, 2025, View Source [SID1234655379]). With the completion of the acquisition, Capstan is now a part of AbbVie.

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Capstan’s lead asset CPTX2309, currently in Phase 1 for the treatment of B cell-mediated autoimmune diseases, is a tLNP that generates CD19-specific, CD8+ in vivo CAR-T cells. The CAR-T cells are designed to achieve rapid and deep B cell depletion with the aim of achieving durable, drug-free remission. This can be accomplished without the need for lymphodepleting chemotherapy, while also avoiding other challenges associated with conventional ex vivo CAR-T therapies.

"With the acquisition now complete, we are excited to work together with the talented team at Capstan to advance our mission of transforming patient care," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "The addition of CPTX2309 and Capstan’s tLNP platform strengthens our ability to deliver new treatments aimed at resetting the immune system and enables application of Capstan’s proprietary technology more broadly for in vivo programming of cells."

On August 19, 2025 Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML) (Press release, Xspray, AUG 19, 2025, View Source [SID1234655396]). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three hours of fasting, currently included in the reference product’s so-called boxed warning, is not expected to apply to XS003. This may simplify treatment and improve adherence.

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XS003 is an improved formulation of nilotinib (Tasigna) and developed using the company’s proprietary HyNap technology.

"Patients with chronic leukemia live not only with their disease—but also with side effects from medications, often related to food interaction and concomitant treatments. Our proprietary HyNap technology addresses these challenges and may help improve treatment outcomes and quality of life for this patient group. Our goal is to develop and commercialize a portfolio of next-generation Protein Kinase Inhibitor products with stable absorption, low variability, and minimal food interaction. With XS003, we now have two product candidates under FDA review with strong clinical potential, addressing a total U.S. market worth USD 2.7 billion," says Per Andersson, CEO of Xspray Pharma.

Data from registration studies demonstrate bioequivalence with the reference product, despite XS003 being administered at less than half the dose of the reference product. In addition, the studies confirm clearly improved dose linearity, which may provide physicians with better predictability when adjusting doses, and thereby a greater ability to achieve improved treatment outcomes. The uptake of XS003 is only slightly affected when taken with food, while the reference product is significantly affected as reflected in their label (28% vs. 82%). This may indicate improved control and a lower risk of side effects when taken with food.

Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter.

Global 2024 nilotinib sales reached USD 1.67 billion in 2024, of which USD 850 million came from the U.S.

On August 19, 2025 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology and chemistry company aiming to revolutionize the development of life-science-based products, reported its financial results for the second quarter ended June 30, 2025 (Press release, Evogene, AUG 19, 2025, View Source [SID1234655380]).

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Mr. Ofer Haviv, Evogene’s President and CEO stated: "Evogene is entering a transformative phase, centered on the strategic repositioning of our business around ChemPass AI – a proprietary, cutting-edge platform for the AI-driven discovery and optimization of small molecules. With a renewed focus on high-impact innovation, cross-industry collaboration, and operational efficiency, Evogene is now uniquely positioned to unlock long-term value in two massive global markets- pharmaceuticals and agriculture.

Earlier this year, we outlined a bold strategic path, and we are now delivering results across five key priorities:

Enhance ChemPass AI as the core engine
Expansion of strategic collaborations in pharma
Integration of AgPlenus activities into Evogene
Enhanced cash flow from subsidiaries
Streamlined operations across the group
In line with these priorities, I’m excited to share with you the major achievements that took place during the second quarter and to date.

In June, we unveiled version 1.0 of our generative AI foundation model, developed in partnership with Google Cloud. Trained on a proprietary dataset of approximately 38 billion molecular structures, this model represents a leap forward in small molecule design, enabling us to address complex, multi-parameter challenges in pharma and ag-tech.

This technology solidifies ChemPass AI’s role as a best-in-class platform, capable of driving innovation at scale and speed.

Last week we announced a collaboration with Tel Aviv University. We partnered with Professor Ehud Gazit, a world-renowned expert in biomolecular self-assembly, to discover small molecule therapeutics targeting metabolic diseases like gout and PKU. This marks the beginning of a broader pharma ecosystem, leveraging ChemPass AI for next-generation drug discovery.

We are optimizing our agricultural offering around ChemPass AI through the integration of AgPlenus’ activity into Evogene, including a 40% workforce reduction at AgPlenus. This integration enhances ChemPass AI’s application in crop protection, unlocking deeper synergies and operational efficiency.

In July 2025, we completed the sale of most of Lavie Bio’s activity and the MicroBoost AI for Ag platform to ICL for a total of $18.71 million. As part of the transaction Lavie Bio redeemed the simple agreement for future equity investment, which was made by an ICL affiliate. This transaction:

Boosted our cash position through direct and indirect proceeds,
Maintained upside via Lavie Bio’s ongoing agreement with an existing partner and
Preserved strategic alignment while creating shareholder value.
As part of a streamlining process, in both Biomica and Evogene, we implemented major restructuring plans:

Biomica reduced staff and management overhead and is now focused on completing its clinical trial for BMC128, its immuno-oncology program (by early 2026) and pursuing potential partners to take the lead on its development programs.
Evogene executed a 30% workforce reduction, with cost savings to be reflected from the third quarter of 2025 onwards.
Another important event, which strengthened our financials and supports the execution of the new strategy, was raising $4.4 million through fully utilizing our existing at-the market facility in June 2025, at an average price of $2.31 per share, reflecting strong market confidence. Combined with the ICL transaction, Evogene now holds a solid 18-month operational runway."

Mr. Haviv continued: "Looking ahead, our unified corporate focus is ChemPass AI – a powerful computational AI engine that will serve two global verticals:

Pharma – Driving discovery of novel small molecule therapeutics.
Agriculture – Enhancing crop protection innovation via AgPlenus.
To accelerate the penetration of our technology into these verticals:

We are building a dedicated business development team in pharma.
We expect to expand our academic and industry collaborations in pharma globally.
AgPlenus will continue strategic engagements with Bayer and Corteva, with new collaborations expected in the future.
We will continue investing in the unique offering of our ChemPass AI’s cutting edge technology.
As to the activity forecast of our subsidiaries:

Lavie Bio: Post-asset sale, focused on maintaining a collaboration with its existing partner. Dividends are expected to flow to Evogene as the majority shareholder. No new initiatives are planned.
Biomica: Advancing toward completion of its clinical trial for BMC128 and exploring potential partners to take the lead on its current development programs. No new initiatives are planned.
Casterra – Although not directly linked to our core technology, it shows strong revenue potential and is expanding into new markets. We have a strong belief in Casterra’s potential as a growth engine and intend to support its continued development.
In summary, Evogene is now a leaner, more focused, and more AI-centric company. With a world-class platform, global partnerships, and a sharpened execution strategy, we are well-positioned to capture substantial value across multi-billion-dollar markets.

We invite investors to join us at this exciting inflection point, as we redefine small molecule innovation for both human health and sustainable agriculture".

Financial Highlights:

Cash Position: As of June 30, 2025, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $11.7 million. The consolidated cash usage during the second quarter of 2025 was approximately $2.4 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $1.0 million in cash during the second quarter of 2025.

Revenue: Revenues for the first half of 2025 were approximately $3.2 million, compared to approximately $2.3 million in the same period the previous year, reflecting an increase of approximately $0.9 million. This increase was primarily driven by higher revenues recognized by Casterra, attributed to seed sales in the first half of 2025, partially offset by a decrease in AgPlenus revenues. Revenues for the second quarter of 2025 were approximately $0.9 million; a slight increase compared to approximately $0.6 million in the same period last year.

R&D Expenses: Research and development expenses, net of non-refundable grants, for the first half of 2025 were approximately $4.8 million, a decrease of approximately $1.7 million compared to $6.5 million in the first half of 2024. The decrease was primarily due to reduced R&D expenses in Biomica and the cessation of Canonic’s operations at the beginning of 2024. In the second quarter of 2025, R&D expenses were approximately $2.3 million, down from $2.9 million in the same period of 2024. This decrease is mainly attributable to decreased expenses in Biomica and Casterra.

Sales and Marketing Expenses: Sales and marketing expenses for the first half of 2025 were approximately $0.8 million, a decrease of approximately $0.3 million compared to approximately $1.1 million in the same period last year. The decrease was mainly due to reductions in Evogene, AgPlenus and Biomica personnel costs. Sales and marketing expenses for the second quarter of 2025 were approximately $0.4 million, reflecting a decrease of approximately $0.2 million compared to approximately $0.6 million in the second quarter of 2024. The decrease was mainly attributable to reduced expenses in Evogene, Biomica and AgPlenus as mentioned above.

General and Administrative Expenses: General and administrative expenses for the first half of 2025 decreased to approximately $2.3 million from approximately $2.9 million in the same period last year. This decrease is mainly attributable to lower personnel costs in Evogene, a reduction in D&O insurance costs, and lower non-cash compensation expenses in Casterra, Biomica, and AgPlenus. General and administrative expenses for the second quarter of 2025 decreased to approximately $1.1 million compared to approximately $1.4 million in the same period of the previous year, primarily due to decreased expenses in Evogene as mentioned above.

Other expenses (income): Other income of approximately $191 thousand was recorded in the first quarter of 2025 as part of the accounting treatment related to a sub-lease agreement. The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, primarily due to the impairment of fixed assets recorded in the first quarter of 2024.

Operating Loss: The operating loss for the first half of 2025 was approximately $6.1 million, a significant decrease from approximately $9.4 million in the same period of the previous year, mainly due to the decreased operating expenses mentioned above. The operating loss for the second quarter of 2025 was approximately $3.1 million, a decrease from $4.6 million in the same period of the previous year, primarily due to the decreased operating expenses mentioned above.

Financing income (expenses), net: Financing income, net for the first half of 2025 was approximately $732 thousand, compared to financing income, net of approximately $373 thousand in the same period of the previous year. The increase is mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising. As a result, during the first half of 2025 the Company recorded net financial income, related to pre-funded warrants and warrants of approximately $663 thousand. Financing expenses, net for the second quarter of 2025 were approximately $393 thousand, compared to financing income, net of approximately $97 thousand in the same period of the previous year. The decrease is mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising.

Loss from operations held for sale, net: Loss from operations held for sale, net for the first half of 2025 was approximately $2.2 million, compared to approximately $0.8 million in the same period of 2024. For the second quarter of 2025, the loss from operations held for sale, net was approximately $1.2 million, compared to approximately $1.4 million in the second quarter of the previous year. These amounts mainly reflect the financial results of Lavie Bio and expenses related to the development and maintenance of MicroBoost AI for Ag, which are presented as a single-line item in the consolidated statements of profit and loss. This accounting treatment follows the intention to sell the majority of Lavie Bio’s activities and the MicroBoost AI for Ag as of June 30, 2025. All prior period amounts were reclassified to conform to this presentation.

Net Loss: The net loss for the first half of 2025 was approximately $7.7 million, compared to approximately $9.8 million in the same period last year. The $2.1 million decrease in net loss was primarily due to decreased operating expenses and increased financing income, net, partially offset by increased loss from operations held for sale, net and reduced revenues. The net loss for the second quarter of 2025 was approximately $4.7 million, compared to approximately $6.0 million in the same period last year. The $1.3 million decrease in net loss was primarily due to decreased operating expenses, decreased loss from operations held for sale and increased revenues, partially offset by increased financing expenses, net as mentioned above.

For the financial tables click here.

Conference Call & Webcast Details: Tuesday, August 19, 2025, 9:00 AM EST 4:00 PM IDT

To join the Zoom conference, please register in advance here

On August 18, 2025 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its unaudited interim results for the six months ended 30 June 2025 (the "Reporting Period") (Press release, Kelun, AUG 18, 2025, View Source [SID1234655363]).

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In the first half of 2025, China’s biopharmaceutical industry reached an inflection point for high-quality growth, driven by accelerated innovation in drug research and development, the rollout of favorable policies, increasing momentum in industry collaboration and mergers and acquisitions. Kelun-Biotech capitalized on these opportunities by its proprietary technology platforms, innovation-led R&D, and a well-established commercialization infrastructure. These elements have worked together to enable the Company to establish a fully integrated model covering R&D, clinical development, manufacturing, and commercialization.

Focusing on addressing significant unmet medical needs in both oncology (such as breast cancer (BC), non-small cell lung cancer (NSCLC), and gastrointestinal (GI) cancers including gastric cancer (GC) and colorectal cancer (CRC)) and non-oncology diseases, the Company has developed a rich and diverse pipeline of over 30 candidates. More than 10 of these candidates have already entered clinical stage. At the same time, the Company continues to invest in next-generation conjugation technologies and a diversified portfolio of assets, aiming to deliver innovative therapies for patients worldwide and contribute to the improvement of global healthcare.

ADC & novel DC assets breakthroughs are redefining the treatment landscape.

sac-TMT (sacituzumab tirumotecan, SKB264/MK-2870,佳泰萊)

The first TROP2 ADC drug approved for marketing in LC globally.

TNBC: Approved by the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC.

HR+/HER2- BC. In May 2025, the NDA for sac-TMT for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the NMPA, and was included in the priority review and approval process. A Phase 3 registrational study of sac-TMT versus investigator’s choice of chemotherapy for treatment of patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- BC who received prior endocrine therapy is in progress.

EGFR-mutant NSCLC. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS compared with docetaxel. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress.

EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT in combination with pembrolizumab are in progress. In June 2025, sac-TMT in combination with tagitanlimab was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations.

Other indications. The Company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC and HNSCC.

Global clinical development. As of August 18, 2025, MSD is progressing 14 ongoing Phase 3 global, multi-center clinical studies for sac-TMT for several types of cancer including BC, LC, gynecological cancer and GI cancer. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing.

Trastuzumab Botidotin (HER2 ADC, A166, 舒泰萊[1])

In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA.

Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ and advanced HER2+ BC based on results from the primary analysis, and the NDA has been submitted to the NMPA.

The Company has initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase 1 inhibitor ADC.

Other ADC Products

SKB315 (CLDN18.2 ADC): the company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.

SKB410/MK-3120 (Nectin-4 ADC): has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410.

SKB571/MK-2750: a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated.

SKB518, SKB535/MK-6204 and SKB445: novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535.

SKB500 and SKB501: novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA.

SKB107: a RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing.

Non-DC asset advancements are diversifying the innovation pipeline.

Tagitanlimab (PD-L1 mAb; A167; 科泰莱):

The first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.

We have received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, we received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA.

Cetuximab N01 (EGFR mAb; A140; 达泰莱)

An EGFR mAb compared with Cetuximab Solution for Injection (Erbitux)

In February 2025, we received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.

A400/EP0031 (RET inhibitor): The Company is currently conducting pivotal clinical studies for 1L & 2L+ advanced RET+ NSCLC as well as a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China. Through the Company’s collaboration and license agreement, Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.

SKB378/WIN378 (TSLP mAb): In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA. The Company’s collaboration partner, Windward Bio, has launched the Phase 2 POLARIS trial in patients with asthma.

SKB336 (FXI/FXIa mAb): The Phase 1 clinical trial has been completed in China.

A296 (STING agonist): A Phase 1 trial is being carried out in China.

Commercialization Accelerates: Sales & Market Access Expanding Footprint

Sac- TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin (舒泰莱) in the China market and file one NDA for A400 in the second half of 2025.

Sales performance: The total commercial sales reached RMB309.8 million for the first half of 2025. Among them, the sales of sac-TMT (佳泰莱) accounted for 97.6%. At the same time, all accounts receivables from sales of pharmaceutical products were collected within the payment period, ensuring efficient and stable cash flow.

Market coverage and academic promotion: Currently, the company’s businesses have covered 30 provinces, over 300 prefectures, and over 2,000 hospitals, where over 1,000 hospitals generated sales, and reached tens of thousands of healthcare professionals through various types of marketing campaigns to convey product and medical professional information. In addition, the company has obtained authoritative endorsement for its products from experts in clinical guidelines, providing further support for the commercialization process.

Commercialization system: The Company has established a fully-fledged marketing team of over 350 people, with a departmental structure that includes marketing, sales, medical affairs, strategic planning and commercial excellence, among other departments, as well as marketing compliance and KA functions. Through the efficient execution of the marketing team, the company has established relationships with multiple leading commercial and distribution groups, including 60+ Tier 1 distributors and 400+ DTP pharmacies. A hierarchical management system for pharmacy retail has been adopted and trainings have been provided to around 4,500 pharmacists in the first half of 2025. By organizing nationwide pharmacy trainings, the company has significantly enhanced the professionalism of terminal services and improved the ability to provide patients with medication guidance.

Market access: In the first half of 2025, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been included in 29, 25 and 15 provincial networks, respectively, ensuring rapid market access through provincial procurement channels. Meanwhile, preparations for the National Reimburesement Drug List (國家醫保藥品目錄) access of marketed products are underway. Currently, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have all passed the preliminary formal examination of National Reimbursement Drug List.

Meanwhile, to further reduce the burden of patients and implement the concept of inclusive healthcare, the company been proactively facilitating the enrollment of sac-TMT (佳泰莱) in provincial and prefecture city level Inclusive Insurance (惠民保). As at the end of the Reporting Period, sac-TMT (佳泰莱) has been enrolled in more than 7 provinces and 20 cities.

Global market: Globally, we will continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.

Global Collaboration Network Expansion & Authoritative Industry Recognition

In the first half of 2025, the Company continued to expand its global collaboration network and deepen partnerships. Working closely with collaborators, it is advancing clinical research worldwide with the goal of maximizing the global value of its pipeline, delivering high-quality medical solutions to patients, and strengthening its leading position in the biopharmaceutical sector.

Collaboration with MSD: As of the date of this announcement, MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as monotherapy or in combination with pembrolizumab or other agents, for several types of cancer including BC, LC, gynecological cancer and GI cancer.

In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has been cleared by the FDA to progress into Phase 2 clinical development. As of June 30, 2025, Ellipses Pharma had set up a total of 36 clinical sites in the United States, Europe and UAE for EP0031.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries).

In the first half of 2025, the Company earned high recognition from professional institutions and industry associations for its outstanding corporate management, product innovation, and strong performance in the capital market. In May 2025, the Company received "Asia’s Best Company" award from FinanceAsia (亞洲金融), as well as a series of awards from Extel, including "Most Honored Company", "Best Company Board", "Best CEO", "Best CFO", "Best ESG" and etc.. The Company was also awarded "IRM OF CHINESE LISTED COMPANIES" by Securities Times (證券時報). In July 2025, the Company was recognized with the "China Pharmaceutical Emerging Innovative Force Award" by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心).

Additionally, the Company continues to strengthen its ESG strategy and improve its ESG governance structure to support sustainable development. The Company has established a comprehensive three-tier ESG governance structure consisting of the Board of Directors, ESG Working Group and ESG Executive Body. Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability.