On May 12, 2025 RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) reported that its phase 3 clinical trial (NCT05302284, study ID: RC48-C016) on disitamab vedotin (DV, brand name: Aidixi), an anti-HER2 antibody-drug conjugate (ADC), in combination with the PD-1 inhibitor toripalimab versus the standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) has reached its primary endpoints of progression-free survival (PFS) and overall survival (OS) (Press release, RemeGen, MAY 12, 2025, View Source;cid=115&id=2596 [SID1234656126]). Statistically significant and clinically meaningful benefits were observed from the strongly positive results of a prespecified interim analysis by Independent Data Monitoring Committee (IDMC). The primary subgroup analysis showed that DV combined with toripalimab significantly improved PFS and OS compared with the standard chemotherapy of la/mUC, irrespective of cisplatin eligibility or HER2 expression level. Furthermore, this regimen exhibited manageable safety profile and tolerable adverse reactions. Detailed data of this study will be presented at major international academic conferences later this year. RemeGen plans to file Biologic License Application (BLA) submission for this indication to the Center of Drug Evaluation of National Medical Products Administration (NMPA) in China.

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RC48-C016 is a randomized, active-control, multi-center phase 3 clinical trial evaluating efficacy and safety of DV plus toripalimab versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2-expressing (defined as IHC 1+, 2+ or 3+) la/mUC. The study was initiated in June 2022 and conducted in 74 sites across China with 484 patients enrolled, the contribution of the investigators and patients is greatly appreciated.

"The strongly positive results of DV in combination with toripalimab as a first-line treatment for advanced urothelial carcinoma are encouraging. DV combined with toripalimab significantly improved PFS and OS, irrespective of cisplatin eligibility or HER2 expression level, which proves the success of HER2-ADC plus immunotherapy and represents a major breakthrough in the treatment of urothelial carcinoma worldwide. It is expected that the excellent performance of disitamab vedotin in subsequent studies will provide better decision-making basis for clinicians, bring more benefits to patients, and reshape the global treatment landscape of urothelial carcinoma with the Chinese regimen,"said Dr. Jun Guo, principal investigator of the study and professor at Peking University Cancer Hospital.

About Disitamab Vedotin

DV is the first novel ADC initially developed by a Chinese company and have been granted conditional approval by NMPA for treatment of gastric cancer and la/mUC in China.

On May 12, 2025 RemeGen Co., Ltd. (688331.SH/9995.HK) reported that the Clinical Trial Application (CTA) for its novel ADC Drug RC278 has been submitted recently and accepted by National Medical Products Administration (NMPA) Center for Drug Reevaluation (CDE) on May 8th (Press release, RemeGen, MAY 12, 2025, View Source;cid=115&id=2650 [SID1234656125]).

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RC278, independently designed and developed by RemeGen, emerges as a potentially First-in-Class/Best-in-Class ADC molecule. RC278 can specifically recognize a new tumor target and contains an innovative linker-cytotoxicity system, showing broad-spectrum antitumor activity, manageable safety and pharmacokinetic characteristics in the pre-clinical study.

As an important drug candidate in RemeGen’s ADC pipeline, RC278 boasts unique target and differentiated molecule design, demonstrating RemeGen’s progress in ADC technology. RC278 will bring new treatment option for the advanced solid tumor patients.

On May 12, 2025 Assertio Holdings reported financial results for the first quarter ended March 31, 2025 (Press release, Assertio Holdings, MAY 12, 2025, View Source [SID1234654207]).

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Said Brendan O’Grady, Chief Executive Officer, "We have achieved substantial progress to date as we implement our business strategy designed to create sustainable near-term growth and increased long-term value as a specialty pharmaceutical company focused on commercial assets. As part of this strategy, Assertio’s 2025 transformation priorities include reducing legal exposure, simplifying our corporate structure and processes, prioritizing investment in growth assets, divesting declining or non-core assets, and using the strength of our balance sheet to close a strategic transaction."

Executing on these priorities through the first quarter, Assertio has:

Settled multiple prior legal matters, including the previously disclosed DOJ False Claims Act qui tam lawsuit, the last remaining Glumetza antitrust action, Spectrum’s legacy Luo securities class action (subject to court approval), and obtained a dismissal of the Company’s Edwards securities class action, reducing future legal costs and further focusing resources on the business.
Begun simplifying its corporate holdings structure by transferring all of its interests in its subsidiary Assertio Therapeutics to an established purchaser of legacy litigation matters resulting in Assertio Therapeutics being owned by the purchaser’s related company, ATIH Industries, LLC. At the closing of this transaction, Assertio Therapeutics held approximately $8.2 million in cash, insurance, a single-digit royalty on Indocin, and certain legal liabilities, including those related to opioid litigation. As a result of this transaction, neither Assertio Holdings nor any of its current subsidiaries are defendants in any opioid-related litigation.
Reallocated corporate resources to focus on growth assets, namely Rolvedon and Sympazan.
Advanced its strategic activities to bring new growth drivers into Assertio’s commercial platform, while also progressing the process to divest non-core assets.
Net Sales and Key Asset Performance

Further, O’Grady said "Looking at the first quarter, net sales came in at $26.0 million, and we are tracking to our full year net product sales and adjusted EBITDA outlook. Rolvedon net sales still finished above our internal expectation, despite Q4 stocking to support customer and volume expansion in Q1, which reflects continued strong demand and commercial execution. As a result, we expect Rolvedon net sales to continue to increase throughout the year. In addition, our revised Sympazan promotional strategy is proving effective, with total Sympazan prescriptions up 6.5% year-over-year in the first quarter. Also, Indocin remained stable in the first quarter, achieving our net sales and contribution expectations."

On May 12, 2025 Cellectis reported financial results for the first quarter 2025, ending March 31, 2025, and provided a business update (Press release, Cellectis, MAY 12, 2025, View Source [SID1234653902]).

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We are making progress in our wholly-owned clinical studies and in the three programs under our strategic partnership with AstraZeneca. We will continue to focus our efforts and resources on advancing these core programs and are looking forward to the results expected over the next few months » said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

On the May 12, 2025 British techbio innovator Etcembly, reported that it has signed a collaboration agreement with DJS Antibodies, a part of AbbVie, to accelerate the discovery of novel antibody therapeutics (Press release, Etcembly, MAY 12, 2025, View Source [SID1234652900]).

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Etcembly’s flagship AI platform, EMLy, stands as the most advanced immune discovery and engineering technology. Bringing together billions of T-cell receptor (TCR) and antibody sequences with cutting-edge bioinformatics, large language models (LLMs) and structural modeling, EMLy enables the exploration of immune system interactions with targets in unprecedented detail.

This inaugural partnership will leverage EMLy’s deep immune repertoire analysis to identify novel antibodies against an undisclosed G protein-coupled receptor (GPCR) target in autoimmune disease.

Michelle Teng, CEO of Etcembly said, "We’ve already showcased EMLy’s ability to discover and optimize picomolar affinity TCRs in months rather than years. With our expanded capabilities now encompassing antibody discovery and engineering, we are thrilled to partner with DJS Antibodies to address challenging targets and drive faster, smarter development of next-generation biotherapeutics.