IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

BEIJING--(BUSINESS WIRE)--Dec 4, 2025--

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers.

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IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen, said: "The IND clearance for IDE034 is an important milestone in the development of this first-in-class TOP1 ADC licensed project, representing a significant advancement for IDEAYA in expanding its clinical pipeline with bispecific, precision-targeted strategies. It also validates our RenLite ® platform and proprietary linker-payload technologies that enable the discovery and optimization of bispecific ADCs. We look forward to seeing IDE034 demonstrate clinical potential across multiple B7H3/PTK7 co-expressing solid tumors, offering new therapeutic options for patients."

Preclinical studies have shown that IDE034 monotherapy induces deep and durable tumor regressions in multiple B7H3/PTK7-positive tumor models, demonstrating strong anti-tumor activity. In addition, IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response and intends to present additional preclinical data supporting the combination rationale at a major medical conference in H1 2026. B7H3 and PTK7 are co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46%, and 27%, respectively, indicating the broad clinical potential of IDE034.

Looking ahead, Biocytogen will continue to provide high-quality source antibodies through RenBiologics to support the clinical translation of licensed projects and actively explore additional early-stage assets for external licensing opportunities.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice ® platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice ® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

KYIV, Ukraine (AP) — Russia unleashed a major missile and drone barrage on Ukraine overnight into Saturday, after U.S. and Ukrainian officials said they’ll meet Saturday for a third day of talks aimed at ending the nearly 4-year-old war.

Russia used 653 drones and 51 missiles in the wide-reaching overnight attack on Ukraine, which triggered air raid alerts across the country and came as Ukraine marked Armed Forces Day, the country’s air force said Saturday morning.

Ukrainian forces shot down and neutralized 585 drones and 30 missiles, the air force said, adding that 29 locations were struck.

At least eight people were wounded in the attacks, Ukrainian Minister of Internal Affairs Ihor Klymenko said.

Among these, at least three people were wounded in the Kyiv region, according to local officials. Drone sightings were reported as far west as Ukraine’s Lviv region.

Russia carried out a “massive missile-drone attack” on power stations and other energy infrastructure in several Ukrainian regions, Ukraine’s national energy operator, Ukrenergo, wrote on Telegram.

Ukraine’s Zaporizhzhia nuclear power plant temporarily lost all off-site power overnight, the International Atomic Energy Agency said Saturday, citing its Director General Rafael Mariano Grossi.

The plant is in an area that has been under Russian control since early in Moscow’s invasion of Ukraine and is not in service, but it needs reliable power to cool its six shutdown reactors and spent fuel, to avoid any catastrophic nuclear incidents.

Ukrainian President Volodymyr Zelenskyy said that energy facilities were the main targets of the attacks, also noting that a drone strike had “burned down” the train station in the city of Fastiv, located in the Kyiv region.

Russia’s Ministry of Defense said its air defenses had shot down 116 Ukrainian drones over Russian territory overnight into Saturday.

Russian Telegram news channel Astra said Ukraine struck Russia’s Ryazan Oil Refinery, sharing footage appearing to show a fire breaking out and plumes of smoke rising above the refinery. The Associated Press could not independently verify the video.

The General Staff of the Ukrainian Armed Forces later said Ukrainian forces had struck the refinery. Ryazan regional Gov. Pavel Malkov said a residential building had been damaged in a drone attack and that drone debris had fallen on the grounds of an “industrial facility,” but did not mention the refinery.

Months of Ukrainian long-range drone strikes on Russian refineries have aimed to deprive Moscow of the oil export revenue it needs to pursue the war. Meanwhile, Kyiv and its Western allies say Russia is trying to cripple the Ukrainian power grid and deny civilians access to heat, light and running water for a fourth consecutive winter, in what Ukrainian officials call “weaponizing” the cold.

The latest round of attacks came as U.S. President Donald Trump’s advisers and Ukrainian officials said they’ll meet for a third day of talks on Saturday, after making progress on finding agreement on a security framework for postwar Ukraine.

Following Friday’s talks, the two sides also offered the sober assessment that any “real progress toward any agreement” ultimately will depend “on Russia’s readiness to show serious commitment to long-term peace.”

The statement from U.S. special envoy Steve Witkoff, Trump’s son-in-law Jared Kushner as well as Ukrainian negotiators Rustem Umerov and Andriy Hnatov came after they met for a second day in Florida on Friday. They offered only broad brushstrokes about the progress they say has been made as Trump pushes Kyiv and Moscow to agree to a U.S.-mediated proposal to end nearly four years of war. Zelenskyy wrote on X on Saturday that he had been given an update over the phone from Florida.

Separately, officials in London said the leaders of the United Kingdom, France and Germany would participate in a meeting with Zelenskyy in London on Monday.

Follow AP’s coverage of the war in Ukraine at https://apnews.com/hub/russia-ukraine

Workers and military inspect Ukrainian Fire Point's Flamingo missiles during handover to the military in an undisclosed location in Ukraine Thursday, Dec. 4, 2025. (AP Photo/Efrem Lukatsky)