Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	2
CD20(B-lymphocyte antigen CD20)	2
CD3 x CEACAM5	1
GABAA receptor(Gamma-aminobutyric acid A receptor)	1
VEGF-A(Vascular endothelial growth factor A)	1

Drugs associated with Shanghai Roche Pharmaceuticals Ltd.

Obinutuzumab

Target

CD20

Mechanism

CD20 inhibitors [+3]

Active Org.

Janssen-Cilag Ltd. [+19]

Originator Org.

Roche Glycart AG

Active Indication

CD20 Positive B-Cell Chronic Lymphocytic Leukemia [+45]

Inactive Indication

CD20 positive Diffuse Large B-Cell Lymphoma [+14]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Nov 2013

ADO-Trastuzumab Emtansine

Target

HER2 x Tubulin

Mechanism

HER2 antagonists [+1]

Active Org.

Genentech, Inc. [+12]

Originator Org.

Genentech, Inc.

Active Indication

Breast Cancer [+10]

Inactive Indication

Advanced breast cancer [+7]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date22 Feb 2013

Pertuzumab

Target

HER2

Mechanism

HER2 antagonists [+1]

Active Org.

Genentech, Inc. [+13]

Originator Org.

Genentech, Inc.

Active Indication

Breast Cancer [+18]

Inactive Indication

Advanced breast cancer [+17]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date08 Jun 2012

Clinical Trials associated with Shanghai Roche Pharmaceuticals Ltd.

NCT06439576 / RecruitingNot Applicable

China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.

Start Date09 May 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

[+1]

CTR20201740 / CompletedPhase 2

一项在既往未经治疗的CD20阳性弥漫性大B细胞淋巴瘤患者中比较利妥昔单抗皮下给药与利妥昔单抗静脉给药分别联合CHOP的药代动力学、有效性和安全性的II期、比较性、开放性、随机、多中心、仅中国研究

[Translation] A phase II, comparative, open-label, randomized, multicenter, China-only study comparing the pharmacokinetics, efficacy, and safety of subcutaneous rituximab versus intravenous rituximab combined with CHOP in patients with previously untreated CD20-positive diffuse large B-cell lymphoma

本研究将评价皮下注射（SC）利妥昔单抗与静脉注射（IV）利妥昔单抗分别联合环磷酰胺、多柔比星、长春新碱、泼尼松（CHOP）治疗既往未经治CD20阳性弥漫性大B细胞淋巴瘤（DLBCL）患者的有效性、安全性和药代动力学（PK）。

[Translation]

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of subcutaneous (SC) rituximab versus intravenous (IV) rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL).

Start Date18 Feb 2021

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+2]

CTR20191103 / CompletedNot Applicable

维莫非尼治疗中国BRAF V600突变型晚期黑色素瘤患者的非干预性研究

[Translation] A non-interventional study of vemurafenib in the treatment of Chinese patients with BRAF V600 mutant advanced melanoma

提供维莫非尼在真实世界中治疗BRAFV600突变型中国晚期黑色素瘤患者的有效性和安全性数据。

[Translation]

To provide the efficacy and safety data of vemurafenib in the real-world treatment of Chinese patients with BRAFV600 mutant advanced melanoma.

Start Date10 Jun 2019

Sponsor / Collaborator

Roche Pharma (Schweiz) AG

[+2]

100 Clinical Results associated with Shanghai Roche Pharmaceuticals Ltd.

0 Patents (Medical) associated with Shanghai Roche Pharmaceuticals Ltd.

Literatures (Medical) associated with Shanghai Roche Pharmaceuticals Ltd.

01 Jun 2024·Journal of Clinical Oncology

BEAT-SC: A randomized phase III study of bevacizumab or placebo in combination with atezolizumab and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC).

Author: Murakami, Shuji ; Ren, Xiubao ; Han, Baohui ; Okamoto, Isamu ; Ohe, Yuichiro ; Katakami, Nobuyuki ; Watanabe, Satoshi ; Yang, Nong ; Hayashi, Morihiko ; Qian, Chunyu ; Li, Gaofeng ; Nakagawa, Yuki ; Liu, Xianling ; Nishio, Makoto ; Yamamoto, Nobuyuki ; Nanki, Toshihiro ; Nogami, Naoyuki

8001 Background: Atezolizumab combined with carboplatin and etoposide is approved as first-line treatment for patients with ES-SCLC, based on results from the Phase I/III IMpower133 trial (NCT02763579). The VEGF inhibitor bevacizumab (bev) is approved for the treatment of many tumor types and has synergistic effects when combined with atezolizumab, as demonstrated by the Phase III IMpower150 study (NCT02366143) in non-small cell lung cancer. BEAT-SC (jRCT2080224946) is evaluating the efficacy and safety of bev combined with atezolizumab and platinum-based chemotherapy in patients with ES-SCLC from Japan and China. Here, we report the primary analysis for progression-free survival (PFS) and the first interim analysis for overall survival (OS) from BEAT-SC. Methods: Eligible patients had measurable ES-SCLC, were aged ≥20 y (≥18 y for patients from China), had an ECOG performance status of 0 or 1 and had no prior systemic treatment for ES-SCLC. Patients were randomized 1:1 to receive 4 cycles (21 days/cycle) of induction therapy with bev combined with atezolizumab + cisplatin or carboplatin + etoposide (ACE) or placebo combined with ACE, followed by maintenance therapy with bev + atezolizumab or placebo + atezolizumab, respectively. The primary endpoint was investigator-assessed PFS (INV-PFS). Key secondary endpoints included OS and safety. Results: The ITT population comprised 333 patients with a median age of 65.0 y; 82.6% of the patients were male, 57.7% were from China, 91.8% received carboplatin and 87.6% were current or former smokers. At data cutoff (June 30, 2023; median follow-up, 10.2 mo), median INV-PFS was 5.7 mo for bev + ACE vs 4.4 mo for placebo + ACE (HR, 0.70; 95% CI: 0.54, 0.90; P=0.0060; 2-sided α boundary=0.05). Median OS was 13.0 mo for bev + ACE vs 16.6 mo for placebo + ACE (HR, 1.22; 95% CI: 0.89, 1.67; P=0.2212; 2-sided α boundary=0.0079). Among the safety analysis population (n=330), bev + ACE was well-tolerated and treatment-related adverse events (TRAEs) were generally similar between treatment arms (Table). Conclusions: BEAT-SC met its primary endpoint, demonstrating that the addition of bev to ACE significantly increased PFS vs placebo + ACE. OS data were immature at the first interim OS analysis, and the numerical OS improvement of bev + ACE was not shown vs placebo + ACE; OS follow-up will continue. No new safety signals were observed. Clinical trial information: jRCT2080224946 . [Table: see text]

02 May 2024·Cancer Research

Abstract PO1-01-04: The optimal neoadjuvant treatment regimen for HR+/HER2+ breast cancer: a network meta-analysis

Author: Wang, Hao ; Xia, Li ; Yu, Xin ; Tang, Hao ; Xie, Weimin ; Mou, Exian ; Liu, Shiwei ; Feng, Yajing ; Yu, Miao ; Mi, Kun

AbstractBackground In patients with the HR+/HER2+ breast cancer (BC) subtype, it can be more challenging to achieve pathological complete response (pCR) after neoadjuvant therapy compared with the HR-/HER2+ subtype. The importance of neoadjuvant therapy and the association of pCR with long-term clinical benefits have been widely demonstrated in HER2+ BC. This network meta-analysis aimed to identify the optimal anti-HER2 regimen, the role of endocrine therapy, and the better chemotherapy choice for the neoadjuvant treatment of HR+/HER2+ BC patients. Methods Literature for neoadjuvant clinical trials in HR+/HER2+ breast cancer was searched in Medline, EMBASE, Cochrane Library, and Web of Science for publications released before June 2023. Single-arm trials, retrospective studies, and observational studies were excluded, as well as studies containing no neoadjuvant phase and/or no anti-HER2 drugs. A network meta-analysis with the fixed-effect model in a Bayesian framework was performed. Odds ratios (ORs) with 95% confidence intervals (CI) for pathological complete response (pCR) analysis and hazard ratios (HRs) with 95% CI for event-free survival (EFS) were calculated. A ranking of treatment patterns was performed using SUCRA. (Registered in PROSPERO: CRD42023385644 Results 2,844 records were identified by the literature search, 60 trials were included after the screening, and valid data were extracted. 19 trials and 2,883 patients were included in the primary analysis of pCR. Compared with trastuzumab + chemotherapy (CT), three treatment regimens showed significantly higher pCR rates, T-DM1 based treatment (T-DM1, OR: 2.83, 95% CI: 1.90, 4.27; which includes T-DM1 alone, T-DM1 + pertuzumab or T-DM1 + endocrine therapy), trastuzumab + pertuzumab + CT (PH, OR: 2.57, 95% CI: 1.70, 3.94), and trastuzumab + tyrosine kinase inhibitor (TKI)+ CT (H+TKI, OR: 1.60, 95% CI: 1.22, 2.09; TKI includes lapatinib, neratinib and pyrotinib). The SUCRA ranking of pCR showed that T-DM1 was ranked first (SUCRA: 0.94), followed by PH (SUCRA: 0.85) and H+TKI (SUCRA: 0.60). PH came first in the SUCRA ranking of EFS (SUCRA: 0.74) as well as cumulative SUCRA combining pCR and EFS (SUCRA: 0.79). For chemotherapy strategies, platinum-containing regimens showed no significant increase in pCR rate compared to no platinum regimens (OR: 1.27, 95% CI: 0.95, 1.69), regimens with anthracycline also had no statistical difference from those without anthracycline (OR: 0.74, 95% CI: 0.51, 1.07). When assessing the impact of endocrine therapy, no significant difference in pCR rate was observed with or without endocrine therapy (OR: 1.18, 95% CI: 0.80, 1.73). Conclusions The PH regimen remains the best neoadjuvant treatment choice for HR+/HER2+ early BC patients considering pCR and EFS outcomes simultaneously. H+TKI did not show significant benefits, so it is not recommended to be given priority in clinical practice. The platinum-containing regimen’s potential benefit compared to the non-platinum regimen is uncertain and needs more clinical investigation. The necessity of adding endocrine therapy is not proven due to limited data availability. Funding: This study was sponsored by Shanghai Roche Pharmaceuticals Ltd. Disclosure: Hao Tang, Shanghai Roche Pharmaceuticals Ltd.: Employee (Ongoing), Salary (Ongoing) Yajing Feng, Shanghai Roche Pharmaceuticals Ltd.: Employee (Ongoing), Salary (Ongoing) Xin Yu, Shanghai Roche Pharmaceuticals Ltd.: Employee (Ongoing), Salary (Ongoing)Citation Format: Hao Wang, Shiwei Liu, Miao Yu, Kun Mi, Exian Mou, Li Xia, Weimin Xie, Hao Tang, Yajing Feng, Xin Yu. The optimal neoadjuvant treatment regimen for HR+/HER2+ breast cancer: a network meta-analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-01-04.

20 Jan 2024·Journal of Clinical Oncology

Atezolizumab and trastuzumab plus chemotherapy in patients with HER2+ locally advanced resectable gastric cancer or adenocarcinoma of the gastroesophageal junction: A multicenter, randomized, open-label phase II study.

Author: Xie, Jessica ; Liu, Hao ; Wang, Zhenning ; Hu, Jiankun ; Yan, Han ; Liang, Han ; Tong, Lin ; Peng, Zhi ; Zhang, Xiaotian ; Zhang, Yanqiao ; Zheng, Zhichao ; Ji, Jiafu ; Sun, Yihong ; Xu, Jiahui ; Shen, Lin

312 Background: Currently, there are no standard perioperative regimens for human epidermal growth factor receptor 2 positive (HER2+) gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Furthermore, despite advances in neoadjuvant or perioperative chemotherapy, the efficacy of treatment for locally resectable advanced GC or GEJ cancer remains unsatisfactory. To address this need, we evaluated the effectiveness of adding atezolizumab (programmed death ligand-1 inhibitor) to treatment with trastuzumab (a HER2 antibody) + capecitabine and oxaliplatin (XELOX) compared with trastuzumab + XELOX in patients eligible for surgery with HER2+ locally advanced GC or adenocarcinoma of the GEJ. Methods: Patients aged 18–75 years were randomized 1:1 to atezolizumab + trastuzumab + XELOX (Arm A) or trastuzumab + XELOX (Arm B) and received the regimen for three neoadjuvant cycles (3 weeks per cycle) and five adjuvant cycles. Treatment administration was atezolizumab 1200 mg, trastuzumab 6 mg/kg, oxaliplatin 130 mg/m2 intravenously on Day 1, and capecitabine 1000 mg/m2 orally twice daily on Days 1–14 of each 3-week cycle. The primary endpoint was the pathological complete regression (pCR) rate. Secondary endpoints were the objective response rate (ORR) during neoadjuvant systemic therapy (NAST) and the R0 resection rate. Time-to-event endpoints are not reported because of immaturity. Efficacy endpoints were analyzed in the intention-to-treat population. The clinical cutoff date for the primary analysis was 12 March 2023. Results: Forty-two Asian patients who provided informed consent were screened and randomized to Arm A (n = 21) or Arm B (n = 21); all patients completed NAST. Most patients were male (92.9%), and the median (range) age was 61 (33–72) years in Arm A and 65 (49–72) years in Arm B. The pCR rate was 38.1% (8/21) in Arm A and 14.3% (3/21) in Arm B (treatment difference: 23.8% [90% confidence interval (CI), 1.3%–44.7%]). The pCR rate was significantly better in Arm A than in Arm B (P = 0.079 <0.1; lower limit of the 90% CI >0). Subgroup analysis showed that age <65 years, male sex, and intestinal Lauren classification were associated with a better pCR rate for the atezolizumab inclusive treatment arm (Arm A); however, these results require further confirmation in future studies. No significant difference was detected between the two arms in ORR during NAST or the R0 resection rate. Conclusions: The addition of atezolizumab to trastuzumab + XELOX therapy was effective in patients with HER2+ locally advanced resectable GC or adenocarcinoma of the GEJ. Clinical trial information: NCT04661150 .

News (Medical) associated with Shanghai Roche Pharmaceuticals Ltd.

22 Nov 2022

·www.globenewswire.com

Kinarus Receives USPTO Notice of Allowance for Lead Therapeutic Candidate KIN001

Method-of-use-patent covers KIN001 in ophthalmic diseasesFurther strengthens already granted KIN001 US composition of matter patent Basel, Switzerland, 22 November 2022. Kinarus Therapeutics Holding AG (SIX: KNRS) (“Kinarus”), a clinical-stage biopharmaceutical company developing novel therapeutics to treat viral, respiratory, and ophthalmic diseases, announced today the receipt of a Notice of Allowability from the United States Patent and Trademark Office (USPTO) for US Patent Application No. 16/500,504 “Methods of preventing or treating Ophthalmic Diseases “ covering its therapeutic candidate KIN001 in age-related macular degeneration (AMD). The method of use patent is on top of granted US Patent No. 11285155 that protects the KIN001 pharmaceutical combination of pamapimod and pioglitazone until at least 2037. The composition of matter protection afforded by Patent No. 11285155 is irrespective of therapeutic indication. Kinarus is currently developing KIN001 as an oral treatment for wet age-related macular degeneration, idiopathic pulmonary fibrosis, and Covid-19. Dr Alexander Bausch, Kinarus CEO, commented: “This USPTO allowance, together with the prior intellectual property secured by Kinarus in the US, EP, Australia, Eurasia, China, ARIPO and other countries, provides an even more secure IP protection for KIN001 in wet AMD and other retinal diseases. The positioning of KIN001 as an oral therapy in the ophthalmology space is unique. Our ambition is that KIN001 will be the first oral therapy used in combination with anti-VEGF therapies to stop progression of wet AMD and other retinal diseases in our aging population.” KIN001-AMD Phase 2 trial. KIN001 is under development as an oral therapy complementing current anti-VEGF drugs with the goal to extend the treatment interval between ocular injections. Kinarus has received regulatory approval to conduct a one-year Phase 2 clinical study in Switzerland and Germany. KIN001 is a combination of two active pharmaceutical ingredients (APIs): pamapimod and pioglitazone. Pamapimod is a highly selective clinical stage small molecule inhibitor of the p38 mitogen-activated protein kinase (p38 MAPK) signaling pathway. Kinarus has found that combining pamapimod with pioglitazone, a safe and well-tolerated marketed drug for the treatment of type 2 diabetes, leads to synergistic efficacy and increased duration of action in preclinical models of wet AMD, IPF and other fibrotic and inflammatory diseases. Kinarus Therapeutics Holding AG (www.kinarus.com) was founded in 2017 by experienced pharmaceutical executives. The Kinarus team utilizes its knowledge and drug development competencies to in-license and develop mid-stage clinical assets which have increased probability of clinical and regulatory success and a rapid path to market. Kinarus possesses the exclusive worldwide license to pamapimod from Roche Pharmaceuticals Ltd. covering all therapeutic indications. Contacts Kinarus Therapeutics Holding AGHochbergerstrasse 60C 4057 Basel, Switzerland+41 61 633 29 71info@kinarus.comInvestors & MediaChris MaggosBioConfidant Sàrl+41 79 367 6254maggos@bioconfidant.ch Legal disclaimer THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO SELL NOR AN INTIMATION TO SUBMIT A PROPOSAL FOR THE ACQUISITION OF SECURITIES OF KINARUS THERAPEUTICS HOLDING AG. THIS PRESS RELEASE IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, INTO OR WITHIN ANY JURISDICTION WHERE IT IS UNLAWFUL TO BE DISTRIBUTED.

License out/inPhase 2

100 Deals associated with Shanghai Roche Pharmaceuticals Ltd.

100 Translational Medicine associated with Shanghai Roche Pharmaceuticals Ltd.

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Pipeline

Pipeline Snapshot as of 24 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Midazolam Maleate ( GABAA receptor )	Anesthesia More	Approved
Tocilizumab ( IL-6RA )	Systemic onset juvenile chronic arthritis More	Approved
Bevacizumab ( VEGF-A )	Non-squamous non-small cell lung cancer More	Approved
Erlotinib Hydrochloride ( EGFR x EGFR L858R x EGFR-Ex19del )	Locally Advanced Lung Non-Small Cell Carcinoma More	Phase 3
ADO-Trastuzumab Emtansine ( HER2 x Tubulin )	HER2 Positive Breast Cancer More	Phase 3

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