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百济神州:港股公告:百济神州有限公司截至2022年9月30日止三个月及九个月未经审核业绩以及业务进展最新情况2022-11-10  

                                                   BeiGene, Ltd.


                                       06160



           2022   9   30


                                                                     13.09
                            571         XIVA

                                                         2022    9     30



                                       2022 9 30
                                           2022                         2022
        2023




                                               (John V. Oyler)

                                   
                                                   55
                                                   

                                        

(CLL)

                            2022


                                   1
                                   (Julia Wang)
                                             29                           9,000

10


2022

                                                              2022 9 30
                                    51                      2021 12 31                           66


          2022    9 30                                                       5.619
               5.576                                                      8,800
            8,370                             2022      9    30                              1.256

                                                        1.087
        1.202                            2022 9       30
                                          6,270

            2022       9     30                              3.876                2021
2.064

          2022     9       30                                             3.495          2021
                           1.925

          2022                            
                                                               1.555
            6,580

          2022                            
                                                                        1.282
                  7,700

          2022                                                                           2,750
                                      2,080                          
                                                                         2022      1
                                                     



          2022
          2,240                                     2,600



                                                2
           2022     9       30                                                     3,810
                             2021                                       
                                                                                   6.5
    2021                                                            3
                               2021            9       30                                              1,400
                                            



             2022       9     30                                           8.260            2021
6.688

                          2022          9      30                                          7,650               2021
                        4,740                                                                                

                                            2021            8                      
                                                                                         2022    1
                    



                          2022          9      30                                          4.264               2021
                        3.519

                                                                                                        2022
               2021
             2,000                   0
                                    2022           9    30
    3,640               2021                             3,170

                    (SG&A)                              2022        9      30                     SG&A
    3.229                               2021                                 2.692               SG&A


                                                       SG&A
    SG&A                                    2022                           2021                      SG&A
                              4,180                         3,540

                            2022        9 30                                                         2,400
        4.384                            5.2% 2021                                       4.623


                        2022        9       30                                        5.576
    0.41                                            (ADS)               5.39                          2021
                4.381                                  0.36                        ADS        4.72
                                                 1.256


                                                                3
   2022                                              82%
                     



   2022                         
                                                    1.555
   136%                     
                               2022                           1.081
     221%
                                                         (MCL)
   (WM)                    (MZL)                        
                                                         2022
   3,950                    23%                                  BTK


   2022                        
                                                      1.282
     67%            




                                         (NICE)                               



    WM                                    

     NICE                       WM



    
                                                              (BTK)
                   BTK
                      58
                                                 
                                                                       25
           4,700

               3    ALPINE                                                  (IRC)
                                      
                                                                        (PFS)


                                                      (MZL)                   

                                         MZL         BTK



                                             4
                             (EMA)                   (CHMP)
              
                                                 (CLL)

                 

        
                             10

    
                                         IgG4     PD-1
                                     Fcγ                   
                                                                                 9
                                                                              

                    30                          11,500

                                     (NMPA)                   (CDE)
    

       (ESCC)                                (sBLA)

        
                                                   (NSCLC)
                                                         (Medsafe)


           

   (MFDS)

                 
                         3          RATIONALE 301
                                  (HCC)                     

                                     2022                        (ESMO 2022)


    ESMO 2022                                            
                                                                      NSCLC      3
      RATIONALE 303

    2022                     (WCLC 2022)                                             

                                                         NSCLC           3
   RATIONALE 303(NCT03358875)




                                         5
             (BGB-A1217)                    Fc              TIGIT
                                           25                         1,500


     WCLC 2022                          
                                                         PD-L1      NSCLC         1
        (NCT04047862)

     ESMO 2022                             
                                                                    NSCLC         1


BGB-11417                               BCL-2                                     

                        BGB-11417                                    10
          300

                                                 2       (NCT05471843)
                   BCL-2      BGB-11417

                   2     BGB-11417-202                                    BGB-11417
             R/R CLL/SLL




       BGB-B167     1       (NCT05494762)                           BGB-B167
                           CEAx4-1BB
       
                        CEA                                               (CRC)

            TIM3   surzebiclimab(BGB-A425)                       
                                                                             NSCLC
                       (HNSCC)                       (NCT03744468)




                                    6


   BGB-A445                                      OX40
   NSCLC HNSCC                                               



   BGB-15025                                       

                                  1(HPK1)

   BGB-16673                                            (CDAC)       BTK
                        B

   BGB-24714                                                           (SMAC)


   BGB-10188                                       

       
                                PI3Kδ

   BGB-23339                                     2(TYK2)




                                                LAG3       LBL-007           

                      900-102                (NCT03744468)





                                                           100             9.3



                   52,000                                        6
            2023
                                                      10


       16,000                                    2022                GMP
                54,000             2023
   10,000


                                         7
     McKesson        Ontada                              Ontada 

                               (RWE)




     



              FDA     CLL                               (SLL)                  (sNDA)
                                                        (PDUFA)     FDA
                    2023   1

           EMA                         CLL

                               CLL      sNDA

           NMPA            CLL/SLL          sNDA

                                                      (MHRA)
   (Swissmedic)     MZL    CLL

                                                 3    ALPINE       (NCT03734016)


         64                    (ASH)                            

                                    
                                                 MZL           MAGNOLIA
                           
                                                                 B
                               12      10        14




                                             8
        



                 NMPA                 
                                                                          PD-L1
                                                                

                                                          (ESCC)
   (BLA)

                    
                                                       sBLA     NMPA

                                         
                                                                                TGA
                 Medsafe           
                                                           NSCLC              ESCC
   BLA                     MFDS              
                                                           ESCC BLA

                                         



   –      FDA                           
                                                       ESCC        BLA


   –      EMA               
                                                       NSCLC                  ESCC


   –        MHRA                            (Reliance route)            

                           NSCLC               ESCC

   –                                               
                                                                ESCC


                           2023              FDA                

                       ESCC                 HCC

BGB-11417 BCL-2

      2022 ASH                                                     (NHL) CLL
          (AML)                             (MM) 1                      NCT04883957
   NCT04277637 NCT04771130                  NCT04973605




                                                9
     Zymeworks        2022         zanidatamab
   HER2          2b          (NCT04466891)




                                                  2022    2021
                                                 9 30    12 31    1




                                             $ 5,072,510 $ 6,624,849
                                                 189,170     483,113
                                                 290,911     242,626
                                                 681,914     587,605
                                               6,726,013   8,535,525


                                                 252,071     262,400
                                                 410,255     558,055
                                                 294,883     407,703
                                                 319,973     390,362
                                                 649,333     629,678
                                               2,070,842   2,402,962
                                             $ 4,655,171 $ 6,132,563

                                10
      ADS                           ADS


                     9 30         3                   9 30         9
                  2022           20211             20221          20211



            $      349,506 $       192,461 $        915,590 $       437,202
                    38,122          13,979          120,236         525,102

                   387,628         206,440         1,035,826        962,304

                    76,543          47,413           212,953         116,361
                   426,363         351,937         1,194,485       1,028,754
                   322,892         269,227           948,868         683,622
                       187             188               563             563

                   825,985         668,765         2,356,869       1,829,300

                   (438,357)      (462,325)       (1,321,043)      (866,996)
                     12,759         (2,230)           34,261        (11,275)
                   (125,640)        31,477          (243,290)        26,487

                   (551,238)      (433,078)       (1,530,072)      (851,784)
                      6,318          5,036            28,408         15,354

                   (557,556)      (438,114)       (1,558,480)      (867,138)


            $         (0.41)         $(0.36) $         (1.16) $        (0.72)


            1,345,303,747 1,205,971,284 1,337,976,853 1,196,391,201

      ADS
            $         (5.39) $        (4.72) $        (15.14) $        (9.42)

ADS
                103,484,904      92,767,022      102,921,296      92,030,092

                          11
1

                           2022                       2021
               2022   9    30   10-Q
     1.                                                          2.




                           740   (ASC 740)




                                         12        (IAS 12)


    2022

                                                               2022    10
2022       9   30




                                                                      2022   9   30

          2022                           2021


                                                              2022
    2021

                                 ADS

                                                                                 2022   9
    30                    10-Q               2.


                                              12
                                                             2021      12     31




                                                 110,424         (110,424)                    –
                                               1,032,069         (110,424)              921,645
                                               8,645,949         (110,424)            8,535,525
                                              (4,966,103)        (110,424)           (5,076,527)
                                               6,242,987         (110,424)            6,132,563
                                               8,645,949         (110,424)            8,535,525




                        2021 9 30                              2021 9 30




                   (19,223)   24,259          5,036     (24,083)        39,437             15,354

                  (413,855)   (24,259)    (438,114)    (827,701)        (39,437)          (867,138)


                     (0.34)     (0.02)        (0.36)        (0.69)          (0.03)           (0.72)
   ADS               (4.46)     (0.26)        (4.72)        (8.99)          (0.43)           (9.42)




2022     9   30                                                      2022     9      30
                                          1,000




                                         13
9,000
                           http://www.beigene.com.cn

                     

        

    
           Pharmacyclics

               1995                               (Private Securities Litigation
Reform Act of 1995)


                                                                   
                                                                       CLL


                                                   Ontada




              10-Q




                                        14
      2022   11   9


       Anthony C. Hooper                             Margaret Han Dugan
    Donald W. Glazer      Michael Goller      Ranjeev Krishana     Thomas
Malley      Alessandro Riva      Corazon (Corsee) D. Sanders




                                   15