• First antibody-drug conjugate facility to receive three provincial regulatory approvals for segmented manufacturing.
• Demonstrated a unified quality system, strict risk assessment protocols, and compliance with rigorous regulatory requirements from development through commercialization.

HANGZHOU, China, July 8, 2026 /PRNewswire/ -- Altruist Biologics, an Innovent Biologics subsidiary and world-class contract development and manufacturing organization (CDMO), announced that its application for segmented production of antibody-drug conjugates (ADCs) at its Hangzhou site successfully passed a comprehensive inspection from three provincial regulatory bodies in China. This is the first case to receive a trilateral approval and marks a further upgrade of the company's ADC manufacturing expertise and integrated capabilities.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, said, "Quality is the foundation of everything we do at Altruist. Our integrated global quality system enables us to consistently deliver the highest standards of compliance, reliability, and operational excellence while supporting the evolving needs of our partners worldwide. As we continue to expand our global capabilities, we remain committed to accelerating the development and manufacture of innovative therapies that help bring life-changing medicines to patients around the world."

Altruist Biologics' Hangzhou site offers a standalone ADC & AXC bioconjugation facility, which supports the manufacture of various bioconjugates including high potency ADCs for clinical and commercial supply in both small- and large-scale production. It includes fully integrated laboratories dedicated to ADC process development, quality control, and MSAT to support seamless progression from development through manufacturing.

The facility features single-use reactor systems supporting conjugation scales of up to 500 L with 1,000 L-5,000 L under construction, ultimately providing the flexibility and capacity required for scalable ADC drug substance manufacturing. It also has fully automated, isolator-based aseptic filling system with two 7.5m² and three 35m² lyophilizers.

It is designed for the safe handling of high-potency APIs (HPAPIs) and incorporates stringent high-containment systems with an Occupational Exposure Limit (OEL) capability of 5 ng/m³, ensuring the highest standards of safety, regulatory compliance, and operational control.

The company has successfully managed over 40 ADC and AXC projects, and has developed ADC molecules spanning from pre-IND to phase three and PPQ. For more information about Altruist Biologics' ADC and bioconjugate capabilities, please visit: www.altruistbio.com.

About Altruist Biologics

Altruist Biologics is a reliable CDMO service provider and wholly owned subsidiary of Innovent Biologics, focusing on the development, clinical, and commercial manufacturing of antibodies, fusion proteins, recombinant proteins, antibody drug conjugates, and other drugs. The company operates advanced cGMP facilities in Suzhou and Hangzhou, China, with a total production capacity of 232,000 liters, and continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility, safety, and agility for clients. With over a decade of bioprocessing expertise, the company has supported the commercialization of 18 drugs and completed more than 2,000 commercial batches with a >99.8% success rate. Its track record includes 100 global regulatory filings with the FDA, EMA, NMPA, PMDA, TGA, and BPOM as well as over 80 successful authority audits. With over 1,000 employees, including leading experts and scientists spanning all areas of biologics production and innovation, Altruist is committed to supporting clients in developing affordable and high-quality biopharmaceuticals for the benefit of patients worldwide.

Media Contact:

Courtney Garcia

Director of Global Marketing & Communications

courtney.garcia@altruistbio.com

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Apotheken in Deutschland erhalten deutlich mehr Handlungsspielraum: Der Bundesrat hat eine Reform der schwarz-roten Koalition passieren lassen, die die Rolle der Offizinen im Gesundheitswesen spürbar aufwertet. Ziel ist es, die wohnortnahe Versorgung zu stärken, Wartezeiten in Arztpraxen zu reduzieren und Prävention sowie Früherkennung auszubauen. Das Paket war zuvor bereits vom Bundestag beschlossen worden.

Kern der Reform ist ein erweitertes Leistungsangebot in Apotheken. Künftig sollen dort zusätzliche Vorsorge- und Früherkennungsuntersuchungen möglich sein, etwa zu Herz-Kreislauf-Erkrankungen, Diabetes oder Angeboten rund um das Rauchen. Apotheken können damit stärker als bisher in der Prävention ansetzen und Risiken identifizieren, bevor es zu manifesten Erkrankungen kommt.

Auch im Impfbereich werden die Kompetenzen ausgeweitet. Neben den bereits etablierten Grippe- und Corona-Impfungen dürfen Apotheken künftig alle Schutzimpfungen mit sogenannten Totimpfstoffen anbieten, darunter etwa Tetanus. Ergänzend werden Blutabnahmen erlaubt, etwa um Medikamentenwirkungen zu kontrollieren. Damit rücken Apotheken näher an klassische ärztliche Tätigkeitsfelder heran, ohne diese vollständig zu ersetzen.

Besonders sensibel ist die neue Möglichkeit, in eng begrenzten Fällen verschreibungspflichtige Medikamente ohne ärztliche Verordnung abzugeben. Erlaubt ist künftig die einmalige Ausgabe der kleinsten Packungsgröße auf Selbstzahlerbasis, wenn ein Arzneimittel seit längerem eingenommen wird und die Fortführung der Therapie keinen Aufschub erlaubt. Die Regelung soll Versorgungslücken schließen, etwa wenn ein Rezept nicht rechtzeitig vorliegt, und bleibt zugleich strikt begrenzt, um Missbrauch zu vermeiden.