Process Development
Product Description
Chime Biologics
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Country/Region:China
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Founded:2013
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On CPHI since:2023
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Certificates:5
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Employees:500 - 999
Company types
Primary activities
Categories
Chime Biologics
-
Country/Region:China
-
Founded:2013
-
On CPHI since:2023
-
Certificates:5
-
Employees:500 - 999
Company types
Primary activities
More Products from Chime Biologics (28)
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Product Durvalumab
lmfinziCLD initiated -
Product Emicizumab
OriginatorBrand HemlibraNMPA IND approved, process at 500Lscale -
Product Evolocumab
EvolocumabCLD ongoing, pool generation ongoing -
Product Ixekizumab
TaltzCLD ongoing, pool generation done (goodtiter/quality data available) -
Product Mepolizumab
NucalaCLD initiated -
Product Pembrolizumab
KeytrudaRCB available, Process developmentongoing (20L process lock run ongoing) -
Product Project Management
We collaborate with you on project objectives and our experienced project management team is responsible to deliver the target goal with highest customer satisfaction.
Our dedicated PMs will be your single point-of-contact throughout the development and manufacturing process, from project custom... -
Product Protein Science
Our protein science group provides comprehensive research services. The analytical development team manages DS/DP release and in-process analytical method development, transfer, optimization, qualification and validation, employing a stage-wise validation strategy aligned with ICH and global regulatory gui... -
Product Quality system
Our top-rated Quality System is designed to meet global regulatory expectation and follows the laws, regulations and rules for CMC activities, including: Requirements of US 21 CFR Part 210, 211, and 600 governing Good Manufacturing Practices (“cGMP”) Requirements of US 21 CFR Part 11 governing ... -
Product Ramucirumab
Ramucirumab biosimilar cdmo -
Product Regulatory Support
We support you with well-versed regulatory service, including consulting/strategic services, scientific advisory meetings, preparing regulatory dossiers and supporting for agency communication/responses preparation.
We have the capabilities and experience of IND/CTA and BLA/MAA/NDA dossier prepa... -
Product Risankizumab
SkyriziCLD initiated
Chime Biologics resources (8)
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News Interview: Biosimilars, a Market Reaching an Inflection Point - A Conversation with Frederic Bouvier
Frédéric Bouvier is a senior biopharmaceutical executive with 25+ years of experience in biologics and biosimilars across Sanofi, Fresenius Kabi, biotech startups, and CDMO organizations. His expertise spans corporate strategy, business development, portfolio build-up, and commercialization, with a strong track record of bringing biosimilars to international markets. -
News INTERVIEW WITH PETER PANG: WHERE BIOSIMILAR CMC RISK REALLY SITS TODAY
In this interview, Peter Pang discusses evolving risks and key considerations for biosimilar CMC amid the growing adoption of CES waivers by regulators. -
Brochure Developing a Robust Manufacturing Process for Pre-filled Syringe Biologics
A prefilled syringe (PFS) is a ready-to-use disposable syringe with a premeasured dose, eliminating the need to draw medication from a vial. -
News Chime Biologics congratulates hope medicine inc on successful phase iii clinical dosing
March 2026, Shanghai, China — Chime Biologics, a leading global CDMO that enables its partners' success in biologics, congratulates its partner Hope Medicine Inc. on the successful dosing of the first patient in the Phase III clinical trial of HMI-115, a novel monoclonal antibody developed for the treatment of endometriosis. This milestone was achieved at the lead site, Peking Union Medical College Hospital, in China. The trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of HMI-115 in treating moderate to severe pain associated with endometriosis. -
News From China, bridging biopharmaceutical innovation in Korea
Recently, the 2026 Hubei–Korea Future Cooperation Exchange Event was successfully held in Wuhan, China. As an important platform for efficient collaboration between Chinese and Korean industries and capital, the event brought together government agencies, financial institutions, well-known enterprises, and industry representatives from both countries to conduct in-depth exchanges on strategic emerging industries, with a focus on biomedicine.
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News Chime Biologics at Bio Equity Europe 2026
At this year’s BIO Equity Europe discussions held in Prague, Czech Republic earlier this month, one message resonated consistently across presentations, panels, and investor conversations: the global biotechnology industry is entering a new era defined by artificial intelligence, accelerated innovation efficiency, and strategic global collaboration.
Representing Chime Biologics, Board Director and CEO Jimmy Wei shared the company’s vision in a featured presentation titled “Turning AI into Biologics Reality”, highlighting how Chime Biologics is integrating China’s rapidly advancing AI ecosystem into end-to-end biologics development and manufacturing capabilities.
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News Chime Biologics, Daewoong Team Up for Global Dupilumab Biosimilar
Wuhan, China & Seoul, South Korea | June 2, 2026 — Chime Biologics, a global biologics CDMO dedicated to enabling partners’ success, and Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, today announced the signing of a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Dupixent.