HANGZHOU, China, November 06 – 2023, HJB announced a new strategic partnership with Hangzhou Apextide Bio-pharmaceutical Technology Company Limited (hereinafter referred to as "Apextide"). This strategic partnership will pursue the marketing and promotion of the APIs and DP manufacturing of oligonucleotide. It takes full advantage of HJB’s expertise in the development and production of oligonucleotide DP and Apextide’s expertise in the R&D and production of oligonucleotide APIs. 

According to the agreement, HJB will enable the acceleration of market expansion of the two parties in the oligonucleotide CMC service to new drug developers with its advanced technology and high-quality service. Through this collaboration, we will jointly promote the research and development and marketing of innovative oligonucleotide drugs, bringing more benefits efficiently to the needy patients.

About HJB

As a CDMO company focusing on the biopharmaceutical field, HJB has extensive manufacturing experience and is able to provide formulation development and production, process development, stability studies and analytical testing for oligonucleotide drugs.

Ø In terms of formulation development, HJB has a mature prescription screening platform equipped with excipients and equipment commonly used in the industry.

Ø In process development, we optimize pH titration and dilution processes to ensure product quality and batch consistency; develop and validate siRNA quality control methods to support process development; and test general physical properties including viscosity, density, osmolality, pH and siRNA concentration.

Ø In terms of stability studies, HJB is able to conduct comprehensive stability studies to assess quality attributes (e.g. pH), acceptability criteria, compatibility, shelf life, and identify potential influencing factors. Stability studies include 40°C, 25°C, freeze-thaw, agitation, container compatibility and clinical use studies.

In addition, by optimizing the filling line assembly, HJB can control the loss in the filling process to less than 100mL, which is much lower than the industry's filling line loss (500 mL), and can result in significant cost savings for our customers. HJB also has extensive experience in the filling of highly concentrated and viscous products, which supports customers in achieving high yields for their projects.

About Apextide

As a one-stop peptide and oligonucleotide CDMO service company, based on 20 years of successful experience in small molecule and peptide drug development and production services from preclinical to commercialization of our parent company Sinopep. Apextide is equipped with the most advanced synthesis equipment in the world, our peptide and oligonucleotide technology platform can provide customers with "one-stop" services from laboratory R&D (gram scale), process development, clinical stage production, to commercialization of oligonucleotide APIs and formulations. The synergy of process, analytical, formulation and regulatory teams provides customers with fast, efficient, professional and flexible integrated solutions for the whole process of oligonucleotide development.

The company has various types of QHPLC/UPLC, LC-MS, LC-MS/MS, IC, GC, GC-MS, ICP-MS and other complete analytical facilities, which provide protection for oligonucleotide structure characterization, analytical method development and validation, GMP production control and final product release testing, stability studies and so on.

The experienced project management system, advanced and complete equipment and facilities as well as customer-centered service concept of Apextide can ensure the rapid response of customer orders from quotation to delivery in all aspects, while the perfect GMP and EHS support system ensures the one-time passing of official audits, including FDA, NMPA, EMA and so on. The concept of win-win cooperation with customers and our professional services can accelerate the drug development process of customers.

Apextide’s 3 major technology platforms:

Ø Solid phase + liquid phase synthesis technology platform, and combined synthesis to achieve optimal yield and purity of peptides and oligonucleotides.

Ø Cyclization technology platform (monocyclic & bicyclic) to improve rigidity and stability.

Ø Coupling technology platform (PDC, POC, ADC, AOC) to improve therapeutic index.

Nootropic and R&D and production capacity:

Oligonucleotide-based therapeutics:

Ø Efficient and rapid R&D production capacity for small nucleic acids, including DNA, ASO, siRNA, PMO, Aptamer and various structural small nucleic acid drugs.

Ø One-stop production capacity for lab-grade, process R&D, clinical stage production to commercialization: lab-grade capacity 3-5kg/year, GMP pilot-grade capacity 10-20kg/year/future capacity 300-500kg (commercial production line under construction).

Ø Customized monomer synthesis (e.g. PMO monomer, currently 10kg/batch, with the ability to scale up to 50kg/batch, annual production capacity of single product can reach 500kg/year)

Ø High purity of 6 commonly used monomers (Purity (HPLC) : ≥99%, Water Content : ≤0.2%) More than 50 kinds of chemical modification methods to meet customer needs

 Peptide therapeutics:

Ø Peptides up to 80 amino acids can be synthesized.

Ø Combined solid-liquid phase synthesis for industry-leading high yields.

Ø One-stop-shop production capacity for lab grams, process development, clinical phase production, to commercialization: 5-10kg/year at lab level, 60-70kg/year at nonGMP level, 10-20kg/year at GMP pilot level/Future Annual Production Capacities 300-500kg (commercial production line under construction) / Headquarter has 250-500kg annual production capacity.

Ø Amino acid monomer customization service.