300759 深市 康龙化成

CMC （ Small Molecule CDMO ） Services
              Facilities

1  Manufacturing Capacity

          Summary


                Facilities – Geographic Location

                                                                      Beijing Headquarters (China)

                                                                       Process – GMP API (OEL 5 µg/m3)

                                                                       OSD Formulation – GMP DP

                                                                       HiPo GMP API (OEL 0.1 µg/m3)

                                                                       Clinical Phase l/ll

Hoddesdon (UK)

 GMP API (OEL 5 µg/m3)                                                                  Tianjin (China)

 Clinical Phase l/ll                                                                         Intermediates

                                                                                         GMP API (OEL 5 µg/m3)

                                                                                         Clinical Phase l/ll/lll

Shaoxing (China) Q4 2021                                                              Ningbo (China)

                                                                                         GMP API (OEL 0.5 µg/m3)
  Intermediates                                                                           OSD Formulation – GMP DP
 GMP API (Commercial)                                                                   Clinical Phase l/ll/lll, NDA &
 Clinical Phase l/ll/lll, NDA &                                                                Commercialization (<30 kg
  Commercialization                                                                        batch)


                API Development Platform

    Process R&D                                Material Sciences
Process Development                                                          Polymorphism Studies

    Route exploration and                                                            Salt and polymorph

    fit-for-purpose R&D                                                                screening

    Commercial process R&D for                                                      Solid state

    late stage APIs                                                                    characterization

Process Safety                                                                  Crystal Engineering

Process Engineering                                                                  Crystallization process

New Chemical Technology                API                          R&D

    Catalysis, hydrogenation,            Service                        Scale up for APIs & INTs

      flow chemistry, biosynthesis          Platform                  Particle Size Control

Kilo Lab (non-GMP & GMP)                                                        Pre-formulation

    QC/QA/RA                                    Manufacturing

Analytical/QC/Stability                                                          Representative Reactions

    Method development and validation                                                Hydrogenations,

    Impurity profiling and forced                                                        organometallic couplings,

    degradation studies                                                                cryogenic conditions, air &
    GT impurity quantitation                                                            moisture sensitive reactions
Quality Assurance                                                              Capacity

    GLP/GMP release, CoA, audit, QMS                                                  >300 reactors

Regulatory Submissions                                                              Reactor size 20 L to 12,500 L
    FDA, EMA, TGA, NMPA                                                      Process Qualification


            Pharmaron Manufacturing Capability

                            IND-Enabling      Phase I & II      Phase III        Commercial

 Beijing GMP Kilo Lab        GMP intermediates, API

 Ningbo GMP Pilot Plant      GMP intermediates, API

    Hoddesdon UK            GMP intermediates, API

                              GMP intermediates, API

 Tianjin Manufacturing        Non GMP Starting Material, Intermediates

        Site

Shaoxing Manufacturing      GMP intermediates , API (Q4 2021)

        Site                  Non GMP Starting Material, Intermediates (Q4 2021)

                                            Pharmaron Confidential                                              5

                Manufacturing Capacity Summary

                  Beijing    Tianjin Site    Ningbo    Hoddesdon  Shaoxing

              GMP Kilo Lab                  Site        Site