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1.2023/04/18 MERCK 108»õ¬ü¤¸²{ª÷¨ÖÁÊ Prometheus Biosciences·¸»ù69%. 193¬ü¤¸¦¬½L»ù
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Prometheus Biosciences stock soars amid $10.8 billion acquisition deal by Merck
Tue, April 18, 2023 at 3:51 AM GMT+8
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www.nejm.org/doi/full/10.1056/nejmoa1610020 Dupilumab ¤GÓ¤T´Á, ¹Ï¤G.
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CNTB ¤½¥q CBP201 AD ¤T´ÁÁ{§É³W¹º: 2023/04/12
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---------------------------------- ¤½§G2022¦~,¥þ¦~°]³ø Connect Biopharma Reports Full Year 2022 Financial Results and Provides Business Update Connect Biopharma Holdings Limited Wed, April 12, 2023 at 4:05 AM GMT+8
Anticipated Upcoming Milestones
CBP-201 in AD:
China pivotal trial: The Company believes it is on track to complete the 36-week stage 2 maintenance phase of the trial in patients with severe-to-moderate AD in the second half of 2023. This stage of the trial includes a once-a-month (Q4W) dosing regimen. Based on feedback received from the CDE, the Company plans to submit an NDA by the end of the first quarter of 2024 for potential approval in 2025.
Global Phase 3 program: The Company is seeking strategic partnerships to advance this product candidate to the next phase of clinical development with potential global and regional partners to provide the necessary infrastructure and deliver a differentiated therapeutic program with improved efficacy and dosing convenience.
finance.yahoo.com/news/connect-biopharma-reports-full-2022-200500465.html
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1.Lebrikizumab AD 2b clinicaltrials.gov/ct2/show/results/NCT03443024
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¹êÅç²Õ¥§¡. 34.8//35.2//53.1//74.6//67.7 ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X- Placebo N=52 15.3//11.4//24.3//45.8//41.1 -------------------------------------------------------- Á`¥§¡ 31.2//30.8//47.7//69.2//62.8
*P<0.05, **P<0.01, ***P<0.001 vs placebo
¡X¡X¡X¡X¡X×¥¿¹ï·Ó²Õ¤Î¥§¡ªºIGA0,1¡X¡X¡X¡X+ 2.CBP-201 AD 2b
www.globenewswire.com/news-release/2022/01/05/2361507/0/en/Connect-Biopharma-Reports-Detailed-Positive-Dataset-from-the-Global-Phase-2b-Trial-of-CBP-201-in-Adult-Patients-with-Moderate-to-Severe-Atopic-Dermatitis.html#:~:text=CBP%2D201%20was%20well%20tolerated,biologic%20standard%20of%20care%20therapy.
IGA0,1//EASI90//EASI75//EASI50//EASI¥§¡°´T ³æ¦ì:% 300 mg Q2W N=57 28.1*//24.6//47.4***//54.4*//63.0*** 300 mg Q4W N=56 21.4//25.0*//41.1**//62.5**//65.4*** 150 mg Q2W N=57 15.8//14.0//40.4**//52.2*//57.5**
¹êÅç²Õ¥§¡¡C 21.8//21.2//46.9//56.3//61.9 ¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@¤@ Placebo N=56 10.7//10.7//14.3//33.9//40.7⋯⋯¤@¤@¤@ -------------------------------------------------------- Á`¥§¡ 19.0/21.1//35.8//50.8//56.7.¡X¡X¡X¡X¡X¡X¡X-(×¥¿IGA0¡A1¬°19.0)
*P<0.05, **P<0.01, ***P<0.001 vs placebo |
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--------------------------------------------------- Lebrikizumab vs CBP-201 AD 2b
1.Lebrikizumab AD 2b clinicaltrials.gov/ct2/show/results/NCT03443024
IGA0,1//EASI90//EASI75//EASI50//EASI¥§¡°´T ³æ¦ì:% 250 mg Q2W N=75 44.6**//44.0***//60.6***//81.0***//72.1*** 250 mg Q4W N=73 33.7*//36.1**//56.1**//77.0**//69.2** 125 mg Q4W N=80 26.6//26.1//43.3//66.4//62.3* Placebo N=52 15.3//11.4//24.3//45.8//41.1 -------------------------------------------------------- ¥§¡ 31.2//30.8//47.7//69.2//62.8
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www.globenewswire.com/news-release/2022/01/05/2361507/0/en/Connect-Biopharma-Reports-Detailed-Positive-Dataset-from-the-Global-Phase-2b-Trial-of-CBP-201-in-Adult-Patients-with-Moderate-to-Severe-Atopic-Dermatitis.html#:~:text=CBP%2D201%20was%20well%20tolerated,biologic%20standard%20of%20care%20therapy.
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*P<0.05, **P<0.01, ***P<0.001 vs placebo
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ASLN ¤½¥q¥²°Ñ¦ÒLebrikizumab 2b ¸ê®Æ¥h¦V¥|¤j¨p¶ÒªÌ»¡©ú¤Î¼ÒÀÀASLAN004 2b 80%¬ù240¤H/5²Õ. ¨ä¤¤¹ï·Ó²Õ¥i§¹¥þ°Ñ·Ó.
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--------------------------------------------------- Lebrikizumab vs CBP-201 AD 2b
1.Lebrikizumab AD 2b clinicaltrials.gov/ct2/show/results/NCT03443024
IGA0,1//EASI90//EASI75//EASI50//EASI¥§¡°´T ³æ¦ì:% 250 mg Q2W N=75 44.6**//44.0***//60.6***//81.0***//72.1*** 250 mg Q4W N=73 33.7*//36.1**//56.1**//77.0**//69.2** 125 mg Q4W N=80 26.6//26.1//43.3//66.4//62.3* Placebo N=52 15.3//11.4//24.3//45.8//41.1 -------------------------------------------------------- ¥§¡ 31.2//30.8//47.7//69.2//62.8
*P<0.05, **P<0.01, ***P<0.001 vs placebo
2.CBP-201 AD 2b
www.globenewswire.com/news-release/2022/01/05/2361507/0/en/Connect-Biopharma-Reports-Detailed-Positive-Dataset-from-the-Global-Phase-2b-Trial-of-CBP-201-in-Adult-Patients-with-Moderate-to-Severe-Atopic-Dermatitis.html#:~:text=CBP%2D201%20was%20well%20tolerated,biologic%20standard%20of%20care%20therapy. IGA0,1//EASI90//EASI75//EASI50//EASI¥§¡°´T ³æ¦ì:% 300 mg Q2W N=57 28.1*//24.6//47.4***//54.4*//63.0*** 300 mg Q4W N=56 21.4//25.0*//41.1**//62.5**//65.4*** 150 mg Q2W N=57 15.8//14.0//40.4**//52.2*//57.5** Placebo N=56 15.3//10.7//14.3//33.9//40.7 -------------------------------------------------------- ¥§¡ 20.2//21.1//35.8//50.8//56.7
*P<0.05, **P<0.01, ***P<0.001 vs placebo
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1. CABENUVA 600mg/900mg ¨C¤G¤ë¤@°w¡AÁv¦Ù¦×ª`®g¡A¥ýªA¨âӤ몺¤GºØ¤fªAÃĪ« ¦~¶O¥Î¡×1114x3x6¦¸¡×20¡A052¬ü¤¸¡C¤Q ¨âӤ몺¤fªAÃÄCabotegravir 30 mg once daily782*2=1562¤QRilpivirine 25 mg once daily 1431*2=2862 ¦Xp¡×24¡A476¬ü¤¸¡þ¦~¤@¤@¤@¶O¥Î«D±`«K©y¡C
Recommended Every-2-Month Dosing Schedule: Initiate injections of CABENUVA (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in for 2 consecutive months and continue with injections of CABENUVA every 2 months thereafter. (2.5)
For gluteal intramuscular injection only ¶È¨ÑÁv¦Ùª`®g
www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf
www.drugs.com/price-guide/cabenuva
200mg/300mg/ml ¨C³æ¦ì1114¬ü¤¸ Cabenuva intramuscular suspension, extended release 2021¦~¤W¥«¡A¦ô2026¦~¡A¦~¾P26»õ¬ü¤¸
2¡ATMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals clinicaltrials.gov/ct2/show/NCT05275998?term=Tmb365+tmb380&draw=2&rank=1
2600mg or 3600mg or 4800mg¨C¤G¤ë¡AÀR¯ßª`®g¤@¦¸¡A 1.2600mgx6=15¡A600mg/¦~¡A15600/400x3024=117¡A936¬ü¤¸¡C 2.3600mgx6=21¡A600mg/¦~¡A3600mg/400*3024=163,296¬ü¤¸/¦~ 3¡A4800mgx6=28¡A800mg/¦~¡A28¡A800/400*3024=217¡A728¬ü¤¸/¦~
Trogarzo Prices, Coupons and Patient Assistance Programs Trogarzo (ibalizumab) is a member of the miscellaneous antivirals drug class and is commonly used for HIV Infection.
The cost for Trogarzo intravenous solution (uiyk 200 mg/1.33 mL) is around $3,024 for a supply of 2.66 milliliters, depending on the pharmacy you visit
www.drugs.com/price-guide/trogarzo
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3/24 ¨p¶Ò(§t»{ªÑÅv)ªº¦ÛµM¤H Mr. Schönharting, ¥»¦¸38,890,515ì©lªÑ ¥ý«e«ùªÑ9,131,810ì©lªÑ --------------------------- ¦Xp48,022,325 (¦û¥¼¨ÓASLN--2024/06/30¤½¥qÁ`«ùªÑ4.8% )
The business address of Mr. Schönharting is c/o NB Capital, Oestergade 24A, 1100 Copenhagen K, Denmark. ir.aslanpharma.com/static-files/8ef0bdc0-36a2-45f0-9424-fe9c5722521d p.10
Mr. Schönharting has served on our board of directors since the Company¡¦s incorporation in July 2005. Mr. Schönharting is a co-founder of the Company. He has also founded or co-founded several other biopharmaceutical companies, including Genmab A/S, Veloxis A/S (f/k/a Life Cycle Pharma A/S), Zealand Pharma A/S and Acadia Pharmaceuticals Inc. Mr. Schönharting has more than 25 years of investment executive experience in public and private equity funds involved in the biopharmaceutical industry. He actively managed BI Healthcare SICAV and BI Bioteknologi SICAV for eight years. Mr. Schönharting currently manages the following funds and certain affiliates of these funds: NB Public Equity K/S, Nordic Biotech K/S, Nordic Biotech Opportunity Fund K/S, NB FP Investment K/S and NB FP Investment II K/S. Mr. Schönharting has an M.Sc. (Econ) from Copenhagen Business School.
Schönharting¥ý¥Í ¦Û¤½¥q©ó 2005 ¦~ 7 ¤ë¦¨¥ß¥H¨Ó¡ASchönharting ¤@ª½¦b§Ú̪º¸³¨Æ·|¥ô¾¡CSchönharting ¥ý¥Í¬O¤½¥qªºÁp¦X³Ð©l¤H¡C ¥LÁٳХߩΦ@¦P³Ð¥ß¤F¨ä¥L´X®a¥Íª«»sÃĤ½¥q¡A¥]¬A Genmab A/S¡BVeloxis A/S¡]f/k/a Life Cycle Pharma A/S¡^¡BZealand Pharma A/S ©M Acadia Pharmaceuticals Inc¡CSchönharting ¥ý¥Í ¦b¯A¤Î¥Íª«»sÃĦæ·~ªº¤½¶Ò©M¨p¶ÒªÑÅv°òª÷¾Ö¦³¶W¹L25¦~ªº§ë¸ê°õ¦æ¸gÅç¡C ¥L¿n·¥ºÞ²z BI Healthcare SICAV ©M BI Bioteknologi SICAV ¤K¦~¡C Schönharting ¥ý¥Í¥Ø«eºÞ²z¥H¤U°òª÷©M³o¨Ç°òª÷ªº¬Y¨ÇÃöÁp¤½¥q¡GNB Public Equity K/S¡BNordic Biotech K/S¡BNordic Biotech Opportunity Fund K/S¡BNB FP Investment K/S ©M NB FP Investment II K/S . Schönharting ¥ý¥Í¾Ö¦³²z¾ÇºÓ¤h¾Ç¦ì¡C (Econ) ¨Ó¦Ûô¥»«¢®Ú°Ó¾Ç°|¡C
About Forward Pharma Forward Pharma A/S is a Danish biopharmaceutical company that from 2005 to 2017 developed a proprietary formulation of DMF for the treatment of inflammatory and neurological indications. The Company granted to Biogen an irrevocable license to all of its IP through the License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion in February 2017, with the return of EUR 917.7 million to shareholders through a capital reduction in September 2017.
Ãö©ó Forward Pharma Forward Pharma A/S ¬O¤@®a¤¦³Á¥Íª«»sÃĤ½¥q¡A±q 2005 ¦~¨ì 2017 ¦~¶}µo¤F¤@ºØ±M¦³ªº DMF °t¤è¡A¥Î©óªvÀøª¢¯g©M¯«¸g¨t²Î¾AÀ³¯g¡C ¤½¥q³q¹L³\¥i¨óij¦V Biogen ±Â¤©¨ä©Ò¦³ª¾ÃѲ£Åvªº¤£¥iºM¾P³\¥i¡A¨Ã©ó 2017 ¦~ 2 ¤ë±q Biogen ¦¬¨ì¤£¥i°hÁÙªº²{ª÷¶O¥Î 12.5 »õ¬ü¤¸¡A¨Ã³q¹L 2017 ¦~ 9 ¤ëªº´î¸ê¦VªÑªFªðÁÙ 9.177 »õ¼Ú¤¸ . |
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clinicaltrials.gov/ct2/show/NCT03443024 A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Actual Primary Completion Date : February 7, 2019
2. DERMIRA, INC.(DERM) ªºLebrikizumab ¼Ú¬w°Ï°Ó·~¤Æ±ÂÅvµ¹ALMIRALL, S.A.¦X¬ù,2019/02/11 ñ¬ù.
OPTION AND LICENSE AGREEMENT
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DATE: FEBRUARY 11, 2019 www.sec.gov/Archives/edgar/data/1557883/000156459019016485/derm-ex101_193.htm
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1.2019/03/18 ¤½§GLebrikizumab 2b AD¸Ñª¼µ²ªG: ªÑ»ùº¦¦Ü11.34(H:14.77/L:11.38)¬ü¤¸,«e¤@¤Ñ(3/17)¦¬½L6.84¬ü¤¸.
2.2019/03/19 13.25¬ü¤¸¥]¾P¶Ò¸ê.1.3»õ¬ü¤¸.
3.2020/01/10 DERM ¤½¥q18.75¬ü¤¸/ªÑ//11»õ¬ü¤¸(2019/Q3°]³ø²bÈ500¸U¬ü¤¸,²{ª÷¬ù3»õ¬ü¤¸/É´Ú¬ù3»õ¬ü¤¸), ³QLily¤½¥q¨ÖÁÊ.
--------------- (1)Dermira Announces Positive Topline Results from Phase 2b
GlobeNewswire www.globenewswire.com › 2019/03/18 › Derm... Mar 18, 2019 ¡X Dermira Announces Positive Topline Results from Phase 2b Study of
(2)Dermira Prices $130.0 Million Public Offering of Common Stock March 19, 2019 19:36 ET | Source: Dermira, Inc.
.MENLO PARK, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced the pricing of its underwritten public offering of 9,811,321 shares of its common stock at a price to the public of $13.25 per share. The gross proceeds to Dermira from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $130.0 million. In addition, Dermira has granted the underwriters a 30-day option to purchase up to an additional 1,471,698 shares of its common stock, on the same terms and conditions. All of the shares will be offered and sold by Dermira.\\\Lilly Announces Agreement to Acquire Dermira
(3)PR Newswire www.prnewswire.com › news-releases › lilly-an... Jan 10, 2020 ¡X (NASDAQ: DERM) today announced a definitive agreement for Lilly to acquire Dermira for $18.75 per share, or approximately $1.1 billion, in an ... |
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§ÚÌ«Ü°ª¿³¦a«Å¥¬¥ô©R Alan Bianchi ¬°°Ó·~º®uÅU°Ý¡C Alan ¬O¤@¦W¥Íª«»sÃÄÀç¾P¥DºÞ¡A¦b¥Ö½§¯f¾Ç©M§K¬Ì¾Ç»â°ì¾Ö¦³Â×´Iªº²£«~°Ó·~¤Æ©M¤W¥«¸gÅç¡C ¦ãÛ¦bÁÉ¿Õµá (Sanofi) ¾á¥ô dupilumab ¥þ²yµo¥¬ªº HCP Àç¾P¥DºÞ¡A³Ìªñ¡A¥L¾á¥ô LEO Pharma tralokinumab ¥þ²yµo¥¬ªº°õ¦æ¸³¨Æ©M¬ü°êÀç¾P¥DºÞ¡C ¦ãÛ±N¦b eblasakimab ªº°Ó·~¾Ô²¤¤¤µo´§«n§@¥Î¡A¦]¬°§ÚÌ´Á«Ý¦b 7 ¤ëªì¬° TREK-AD ¬ã¨sŪ¥X³»½u¼Æ¾Ú¡C
We are pleased to announce the appointment of Alan Bianchi to the role of Commercial Lead Advisor. Alan is a biopharmaceutical marketing executive with extensive product commercialization and launch experience in dermatology and immunology. Alan held the role of Head, HCP marketing at Sanofi for the global launches of dupilumab, and most recently, was the Executive Director and US Marketing Lead for the global launches of tralokinumab at LEO Pharma. Alan will play an important role in the commercial strategy for eblasakimab as we look forward to a topline data readout in early July for the TREK-AD study.
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At 16 weeks, more patients treated with CBP-201 achieved an IGA score of 0-1 (clear or almost clear skin) and a 2-point IGA reduction than those on placebo (30.3% vs. 7.5%). ¡K30.3%/7.5%=400%,®t4¿¡B¡K¡K
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µoªí®É¶¡:2023/3/31 ¤U¤È 11:58:18
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CBP201 2b ¥Dn«ü¼ÐEASI ¥§¡´î´Tªí²{ªº¤£®t¡C ®tªº¬O¤T´Á¥Dn«ü¼ÐIGA0,1 ©Ò¥H¶Ò¤£¨ì2»õ¬ü¤¸¡A¤T´ÁÁ{§É¶}¤£¤F¡C
finance.yahoo.com/news/connect-biopharmas-atopic-dermatitis-candidate-132409085.html
Connect Biopharma¡¦s Atopic Dermatitis Candidate Shows Rapid, Sustained Improvement Across All Body Regions
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Connect Biopharma Holdings Limited (NASDAQ: CNTB) announced post hoc data analysis from the Phase 2b CBP-201 global trial in moderate-to-severe atopic dermatitis (AD).
The data exhibited that CBP-201 led to rapid and sustained improvement in AD signs and symptoms across all four body regions, compared to the placebo.
EASI subscores improved in all four body regions across 16 weeks of treatment.
Improvements between 300 mg Q2W and Q4W were comparable. At Week 2, EASI decreased by -26.3% (head/neck), -26.4% (trunk), -21.6% (upper limbs), and -23.2% (lower limbs) for patients on CBP-201 300 mg Q4W treatment vs. -9.5% to -15.7% with placebo.
At Week 16, EASI decreased further to -69.2% (head and neck), -72.1% (trunk), -64.2% (upper limbs), and -68.5% (lower limbs) vs. -21.2% to -49.1% with placebo (p<0.01 per region).
Researchers also observed improvement for each classification of AD symptoms (signs): erythema, induration/papulation, lichenification, and excoriation, within each body region.
Concurrently, the company also announced data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD), exhibiting rapid relief from symptoms.
The study met primary and secondary endpoints, with mostly mild-to-moderate adverse effects reported.
At 16 weeks, more patients treated with CBP-201 achieved an IGA score of 0-1 (clear or almost clear skin) and a 2-point IGA reduction than those on placebo (30.3% vs. 7.5%).
62.9% of CBP-201 patients achieved a 75% skin clearance (EASI-75), versus 23.4% in the placebo group and EASI-90 of (35.8% vs. 63.%).
Price Action: CNTB shares are up 20.90% at $1.33 during the premarket session on the last check Monday. |
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