Established in August 2014, Shenzhen TargetRx is a Sino-American joint venture that specializes in the research and development of targeted drugs. The company has received investments from prominent angel investors in China. The company aims to become a global leader in the development of targeted drugs, particularly in the field of small molecule anti-cancer drugs. Shenzhen TargetRx has dedicated itself to developing innovative anti-tumor drugs to improve the lives of cancer patients. It is focused on designing, screening, evaluating, optimizing, and researching a series of original, third-generation small molecule anti-tumor drugs with independent intellectual property rights. The company aims to overcome the challenge of acquired drug resistance and work towards transforming cancer into a chronic disease.

Tags

Neoplasms

Hemic and Lymphatic Diseases

Immune System Diseases

Small molecule drug

Chemical drugs

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	7
Hemic and Lymphatic Diseases	6
Immune System Diseases	3
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	6
Chemical drugs	2

Top 5 Target	Count

BTK(Tyrosine-protein kinase BTK)	1
ALK x ROS1	1
PDGFRα x c-Kit	1
SMN2(Survival motor neuron protein)	1
Bcl-2 x Bcl-xl	1

Drugs associated with Shenzhen TargetRx, Inc.

Deulorlatinib

Target

ALK x ROS1

Mechanism

ALK inhibitors [+1]

Active Org.

Shenzhen TargetRx, Inc.Startup

Originator Org.

Shenzhen TargetRx, Inc.Startup

Active Indication

ALK positive Non-Small Cell Lung Cancer [+1]

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

TGRX-678

Target

Bcr-Abl T315I

Mechanism

Bcr-Abl T315I inhibitors

Active Org.

Shenzhen TargetRx, Inc.Startup

Originator Org.

Shenzhen TargetRx, Inc.Startup

Active Indication

Aggressive-Phase Chronic Myelocytic Leukemia [+2]

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

TGRX-814

Target

Bcl-2 x Bcl-xl

Mechanism

Bcl-2 inhibitors [+1]

Active Org.

Shenzhen TargetRx, Inc.Startup

Originator Org.

Shenzhen TargetRx, Inc.Startup

Active Indication

Acute Myeloid Leukemia [+3]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shenzhen TargetRx, Inc.

NCT06484816 / Not yet recruitingPhase 1

A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients With Advanced Solid Tumor and/or Relapsed/Refractory Hematologic Malignancies

A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies

Start Date31 Jul 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

[+1]

CTR20241642 / Active, not recruitingPhase 1

[14C]TGRX-326在中国成年男性健康受试者中的物质平衡研究

[Translation] Study on the material balance of [14C]TGRX-326 in healthy Chinese adult male subjects

主要研究目的：定量分析健康受试者单次口服[14C]TGRX-326后排泄物中的总放射性，获得人体放射性排泄率数据，评估TGRX-326在人体内的主要排泄途径；获得受试者口服[14C]TGRX-326后人血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，评估TGRX-326在人体内的主要代谢途径；定量分析受试者单次口服[14C]TGRX-326后全血和血浆中的总放射性，获得血浆总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况；次要研究目的：采用已验证的LC-MS/MS方法定量分析血浆中TGRX-326及其代谢产物（如适用）的浓度，获得血浆中TGRX-326及其代谢产物（如适用）的药代动力学参数；评估[14C]TGRX-326单次给药在健康受试者中的安全性。

[Translation]

The main research objectives are: to quantitatively analyze the total radioactivity in the excreta of healthy subjects after a single oral administration of [14C]TGRX-326, obtain human radioactivity excretion rate data, and evaluate the main excretion pathway of TGRX-326 in the human body; to obtain the radioactive metabolite spectrum of human plasma, urine and feces after the subjects took [14C]TGRX-326 orally, identify the main metabolites, and evaluate the main metabolic pathway of TGRX-326 in the human body; to quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]TGRX-326 in the subjects, obtain the pharmacokinetic parameters of the total radioactivity in plasma, and examine the distribution of the total radioactivity in whole blood and plasma; Secondary research objectives: to use a validated LC-MS/MS method to quantitatively analyze the concentration of TGRX-326 and its metabolites (if applicable) in plasma, obtain the pharmacokinetic parameters of TGRX-326 and its metabolites (if applicable) in plasma; to evaluate the safety of a single dose of [14C]TGRX-326 in healthy subjects.

Start Date20 Jun 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

NCT06088888 / RecruitingPhase 1

A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

Start Date15 Jun 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

[+1]

100 Clinical Results associated with Shenzhen TargetRx, Inc.

0 Patents (Medical) associated with Shenzhen TargetRx, Inc.

Literatures (Medical) associated with Shenzhen TargetRx, Inc.

02 Nov 2023·Blood

Tgrx-678, a Novel Allosteric Inhibitor of BCR-ABL1, Demonstrates Preclinical Anti-Leukemia Activity, High Oral Bioavailability and Synergism with Ponatinib to Suppress the Highly Resistant Compound Mutations

Author: Jiang, Qian ; Wang, Yihan ; Jiang, Shuzhen ; Shi, Yanxia ; Zheng, Cuifang ; Yan, Tingting ; Li, Linxin ; Ai, Yixin

IntroductionClinical resistance to the treatment of BCR-ABL1-positive chronic myeloid leukemia (CML) patients is often conferred by mutation(s) in the ATP-binding site of ABL1 kinase domain. ABL1 is subject to auto-inhibition mediated by myristoylation-triggered conformational change, which can be exploited to overcome resistance, as validated by allosteric inhibitors such as GNF2, GNF5 and asciminib. TGRX-678, a novel allosteric inhibitor designed to target the myristoyl pocket of ABL1, is currently being investigated in a phase I clinical trial (NCT05434312). Herein we report the selectivity, potency, anti-leukemia activity and in vivo pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of TGRX-678.MethodsFor in vitro study, ABL1b 65-534 fragments were used following the protocol for Z'-LYTE kinase assay kit (Thermo Fisher). For cellular assays, CML cell lines or engineered Ba/F3 cells were incubated with titrating TGRX-678 for 72 hrs, then CellTiter Glo reagent (Promega) was added and the chemiluminescence was measured. For in vivo studies, SD rats received TGRX-678 or asciminib and plasma samples were collected for analysis. NOD-SCID mice were inoculated with CML or Ba/F3-BCR-ABL1 T315I cells and received oral TGRX-678. Tumor volumes and body weights were recorded for 3 to 5 weeks.ResultsTGRX-678 exhibited minimum off-target inhibition at 1 μM in a panel of 298 kinases, but inhibited the enzymatic activity of both ABL1 and the T315I mutant with IC50 values of 2.96 nM and 1.15 nM, respectively.The anti-proliferative activity of TGRX-678 was determined in CML cell lines including K562, KU812, KCL22-S, KCL22-R, LAMA-84 and MEG-01 with IC50 values ranging from 1.1 nM to 6.56 nM. TGRX-678 had no cytotoxicity in 29 cell lines representing other hematological malignancies and solid tumors. Using engineered Ba/F3 cell lines, TGRX-678 was active against the native BCR-ABL1 (IC50 = 4.11 nM) and the clinically prominent mutants including G250E (IC50 = 2.49 nM), Q252H (IC50 = 2.38 nM), Y253H (IC50 = 5.6 nM), E255K (IC50 = 1.01 nM), E255V (IC50 = 2.73 nM) and T315I (IC50 = 66.1 nM). The cellular activity of TGRX-678 was attenuated by mutations in the myristoyl pocket such as A337V, P465S, V468F and I502L or mutations in the SH3-kinase domain interface including P223S and K294E, underpinning its allosteric mode of action.In SD rats, oral administration of TGRX-678 at 20 mg/kg achieved a maximum plasma concentration (C max) of 2369 ng/mL, which was 1.3-fold higher than that of asciminib. The overall exposure (AUC last) of TGRX-678 (23,147 h·ng/mL) was also 1.7-fold higher than that of asciminib. The oral bioavailability of TGRX-678 was 62%. In xenograft-bearing mice, oral dosing of TGRX-678 at 1 mg/kg QD (for KU812) or 3 mg/kg QD (for K562) was sufficient to completely inhibit tumor growth. In the Ba/F3-BCR-ABL1 T315I xenograft mice, TGRX-678 induced dose-dependent tumor regression and reduced tumor volume by 67% at 45 mg/kg QD dose.We further examined the synergistic effect of TGRX-678 and ponatinib combination. While each agent was inactive to the Y253H/T315I mutant, the combination of TGRX-678 and ponatinib inhibited cell proliferation at suboptimal concentrations. The addition of TGRX-678 dramatically lowered the IC90 for ponatinib from 1489 nM to 60.9 nM, whereas asciminib only reduced the IC90 to 165 nM (Figure A). Similarly, while ponatinib alone had limited effect on cell viability of the E255V/T315I, Q252H/T315I and T315M mutants, the addition of TGRX-678 at a clinically achievable concentration of 720 nM significantly reduced cell viability to 0-10 % (Figures B-D). In comparison, the addition of asciminib at a much higher concentration of 6000 nM only reduced cell viability to 5-29% (Figures B-D).ConclusionOur findings support that TGRX-678, a novel allosteric inhibitor of BCR-ABL1, is potent against the CML cells and cell lines harboring clinical ATP-site mutations with minimum non-specific cytotoxicity. TGRX-678 exhibits a favorable PK profile and anti-tumor activity in vivo. Furthermore, TGRX-678 and ponatinib synergize to overcome the clinically challenging resistance conferred by T315M or T315I-inclusive compound mutations. This data warrant further clinical investigation of TGRX-678 for the treatment of resistant or refractory CML patients.

02 Nov 2023·Blood

Safety and Efficacy of Tgrx-678, a Potent BCR-ABL Allosteric Inhibitor in Patients with Tyrosine Kinase Inhibitor (TKI) Resistant/Refractory Chronic Myeloid Leukemia (CML): Preliminary Results of Phase I Study

Author: Liu, Zhuogang ; Jiang, Qian ; Liu, Zhenfang ; Weng, Jianyu ; Liu, Bingcheng ; Cao, Jingrong ; Weiming, Li ; Chen, Suning ; Wang, Yihan ; Wang, Qiang ; Zhang, Yanli

Background:TGRX-678 is a novel allosteric inhibitor of ABL kinases, specifically targeting the ABL Myristoyl Pocket (STAMP). In vitro data supports TGRX-678 targeting the most common BCR-ABL mutations, including T315I. Here we report an open-label, first-in-human study to evaluate the safety, preliminary efficacy, and pharmacokinetic properties of orally administered TGRX-678 in patients with resistant/refractory CML.Methods:This study included dose escalation and expansion phases. During dose escalation patients with CML in chronic or accelerated phase (CP or AP) and who had failed ≥3 prior TKIs were enrolled. Patients received orally a single dose, after a 3-5 day observation, continuously daily doses ranging from 10 to 80 mg (BID) or 40 to 240 mg (QD) were given. Dose escalation followed an adaptive Bayesian logistic regression model based on dose-limiting toxicities (DLTs) occurring in cycle 1 (28 Days). Dose-expansion had three cohorts: CML-CP without T315I mutation with ≥2 prior TKIs, CML-CP with T315I with ≥1 prior TKIs, and CML-AP with ≥1 prior TKIs. The eligible patients received continuous treatments until disease progression, intolerant toxicity, consent withdrawal, or death.Results:From April 30, 2021 to July11, 2023, 95 (CP n = 58, AP n = 37) patients were treated with TGRX-678 at the BID doses including 10 mg (n = 3), 20 mg (n = 6), 40 mg (n = 5), and 80 mg (n = 3), and QD doses including 40mg (n=18), 80 mg (n = 6), 160mg (n= 4) and 240mg (n=50). 40 (42%) patients were female. The median age was 45 (range 35-52) years and the median interval from diagnosis to initial TGRX-678 treatment was 97 (range 28-136) months. Median treatment duration was 8 (range 6-13) months. At baseline, 93 (98%) patients had received ≥2 lines of prior TKI therapy, among them, 78 (82%) received ≥3 lines of prior TKIs, 44 (46%) received ≥4 lines of prior TKIs. 46 (48%) patients had ≥1 ABL mutation and 28 (30%) had T315I mutation.Of 58 patients with CML-CP, 16 (89%) achieved complete hematologic responses (CHR), 25 (43%) major cytogenetic responses (MCyR), 19 (33%) complete cytogenetic responses (CCyR), and 11 (19%) major molecular responses (MMR). Of 14 CML-CP patients with T315I mutation, 9 (100%) achieved CHR, 9 (62%) MCyR, 8 (57%) CCyR and 7 (50%) MMR. Of 35 CML-CP patients without any ABL mutations, 12 (100%) achieved CHR, 11 (31%) MCyR, 6 (17%) CCyR and 1 (3%) MMR (Fig. A). Of 9 CML-CP patients with other ABL mutations, 4 (67%) achieved CHR, 5 (56%) MCyR, 5 (56%) CCyR and 3 (33%) MMR (Fig. B). Of 37 CML-AP patients, 31 (84%) had major hematologic response, 13 (35%) MCyR, and 9 (24%) CCyR (Fig. C).There were 22 CML-CP and 23 CML-AP patients previous received 3 rd Gen TKIs (ponatinib or HQP1351) or asciminib. Of 22 CP patients, 21 (95%) achieved CHR, 4 (18%) MCyR and 3 (14%) CCyR. Of 23 CML-AP patients, 17 (74%) achieved CHR, 5 (22%) MCyR and 3 (13%) CCyR.The PK results suggested that TGRX-678 exposure (C max and AUC tau) was dose-proportional within range of 10mg~80mg BID or 40mg~240mg QD. The elimination of TGRX-678 in human plasma is slow, and the half-life (T1/2) of which is about 120 hours. At steady state, the accumulation ratios of C max and AUC tau are 3.7-8.0 and 5.4-11.8, respectively. The high accumulation ratio of TGRX-678 resulted in not only an increase of plasma exposure, but also a decrease of the gap between C max and C trough (Fig. D).7 DLTs were observed, one case of elevated alanine aminotransferase at 20 mg BID and five cases of thrombocytopenia at 40mg QD (1), 40mg BID (2) and 80mg QD (2) and one hepatic function abnormal at 240 mg QD. However, MTD was not reached according to protocol criteria. Most treatment-related adverse events (TRAEs) were grade 1-2. AEs ≥ grade 3 that happened more than 5% were thrombocytopenia (50%), neutropenia (42%), anemia (24%) and hypertriglyceridemia (9%). In total 15 patients discontinued the study due to disease progression (5, all APs), intolerance (2), physician's decision (2), consent withdrawal (6). There was one death occurred which was not drug related.Conclusions:Clinical activity of TGRX-678 was seen in all cohorts and across TKI-resistant mutations including T315I, providing a promising treatment option for CML CP/AP patients, including those who failed ponatinib or asciminib. Its unique PK properties might bring additional benefit to patients. TGRX-678 was well tolerated in heavily pretreated CML patients. Currently two doses were selected to optimize the RP2D.Study Identifier: NCT05434312.

News (Medical) associated with Shenzhen TargetRx, Inc.

03 Sep 2024

·endpts.com

Denali details accelerated approval plans; Jazz's $850M private offering

Plus, more news about Circle Pharma, Emergent, Cytokinetics, Nxera Pharma, Neurocrine Biosciences, Simcere Zaiming, TargetRx and Calliditas: Denali Therapeutics to seek accelerated approval in 2025: The decision to seek an expedited OK for its Hunter syndrome program, called DNL310, follows a years-long debate over whether heparan sulfate can serve as an effective surrogate biomarker for certain neurodegenerative diseases. Denali said that the FDA agreed that heparan sulfate levels in the cerebrospinal fluid are “reasonably likely to predict” a clinical benefit. Denali also plans to submit data on the neurofilament biomarker that Biogen used to get an ALS drug approved last year for certain genetic forms of the disease. Regenxbio, with whom Denali is competing in Hunter syndrome, is expected to launch a rolling submission for accelerated approval by the end of this month. — Max Gelman Jazz to launch $850M private offering: The offering , coming in the form of “exchangeable senior notes due in 2030,” will help pay down about $350 million of Jazz’s outstanding loans. — Max Gelman Circle Pharma closes $90M Series C: Circle said in July it was seeking to bring in $117 million when the company raised $54 million as part of its Series C round. The money will be used to fund Circle’s cyclin A/B RxL inhibitor, CID-078, in various tumor types. — Max Gelman Emergent BioSolutions gets $250M loan: The money from Oak Hill Advisors is being used to repay the remaining outstanding loan that Emergent took out in 2018. Emergent’s debt is expected to be reduced by about $200 million by the end of this year, CEO Joe Papa said in a statement. Its stock $EBS was down about 9% on Tuesday morning. — Max Gelman Cytokinetics touts more Phase 3 data for aficamten: In the open-label FOREST-HCM trial, a subgroup of 59 hypertrophic cardiomyopathy patients taking aficamten successfully scaled down their standard of care medication, which is defined as a minimum 50% dose reduction in at least one drug from baseline, according to results presented Sunday at the European Society of Cardiology’s annual meeting. Cytokinetics is currently preparing regulatory filings for the cardiac myosin inhibitor. — Ayisha Sharma Nxera Pharma gets $35M payment from Neurocrine Biosciences: Completing the Phase 2 trial for its candidate in adults with schizophrenia triggered the payment for Nxera, previously known as Sosei Heptares. The trial met the primary endpoint, and Nxera plans to move the muscarinic M4 selective agonist into Phase 3 trials next year. — Katherine Lewin Simcere Zaiming pays $20M to TargetRx for cancer asset: The oncology-focused biopharma is giving $20 million to Shenzhen TargetRx for commercial rights to a Phase 1 antitumor small molecule candidate in China. Simcere will gain marketing rights to TGRX-326 as well as other benefits and will compensate TargetRx for helping to promote the drug. — Anna Brown Calliditas Therapeutics will delist following purchase by Asahi Kasei: Asahi now owns more than 90% of the company’s outstanding shares per its offer to purchase all shares of the Stockholm-based company. The delisting of the American shares is expected to occur around Sept. 23. — Katherine Lewin

Phase 1Phase 3Phase 2Acquisition

03 Sep 2024

·www.pharmaceutical-technology.com

Simcere Zaiming and TargetRx agree TGRX-326 commercial rights

The asset has potential in treating non-small cell lung cancer patients with ALK/ROS1 fusion genes and resistance to multiple ALK mutations. Credit: JOURNEY STUDIO7/Shutterstock. Simcere Zaiming has entered a collaboration deal with Shenzhen TargetRx to bring the third-generation anaplastic lymphoma kinase (ALK) inhibitor, TGRX-326, to the Chinese market. Simcere Zaiming will hold exclusive commercial rights for TGRX-326 in Mainland China. These rights include marketing, strategy development and entitlement to related benefits from the asset. TargetRx is entitled to receive an upfront payment of more than $20m and will also be compensated by Simcere Zaiming for promotional efforts. TargetRx chairman Dr Yihan Wang stated: “TGRX-326 is a potentially best-in-class novel anti-tumour molecule independently developed by TargetRx. See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Combating Pharmaceutical Crime with On-Dose Authentication “It is a third-generation ALK inhibitor in late-stage clinical development which may bring a better option for patients. We believe that with the support of Simcere Zaiming, we will be able to bring this product quickly to the market.” TGRX-326 is a clinical-stage anti-tumour candidate,designed to inhibit both ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases. The asset is claimed to have potential in treating non-small cell lung cancer (NSCLC) patients with ALK/ROS1 fusion genes and resistance to multiple ALK mutations, including the G1202R mutation. In its preclinical and Phase I clinical trial stages, TGRX-326 showed strong anti-tumour efficacy and a favourable safety profile. The molecule penetrates the blood-brain barrier, crucial for treating NSCLC patients with brain metastases. Simcere Zaiming chairman Dr Renhong Tang stated: “We are pleased to collaborate with TargetRx on novel dual-targeted therapy for lung cancer, a major malignancy that Simcere Zaiming strategically focuses on. “This partnership will further enhance our innovative product portfolio. ALK/ROS1 fusion is a critical genetic mutation in non-small cell lung cancer. The advancement of targeted therapies has significantly improved survival rates for these patients. However, there remains a substantial need for new treatments with better efficacy and the ability to overcome drug resistance.” In June 2024, the China National Medical Products Administration granted marketing approval for Simcere Zaiming’s Enlituo for metastatic colorectal cancer .

VaccinePhase 1Drug ApprovalClinical ResultLicense out/in

02 Sep 2024

·www.prnewswire.com

Simcere Zaiming collaborates with TargetRx to introduce a third-generation ALK inhibitor

NANJING, China, Sept. 2, 2024 /PRNewswire/ -- On September 02, 2024, Simcere Zaiming, an innovative oncology company under Simcere Pharmaceutical Group (2096.HK), announced a collaboration agreement with Shenzhen TargetRx Inc. The partnership focuses on the ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326, a clinical-stage anti-tumor candidate. According to the terms of the agreement, Simcere Zaiming will acquire exclusive commercial rights to TGRX-326 in Mainland China. These rights encompass but are not limited to marketing promotion, strategy formulation and adjustment, and the right to obtain relevant benefits from TGRX-326. TargetRx will receive an initial payment exceeding $20 million. Additionally, TargetRx will compensate Simcere Zaiming for promotional services. TGRX-326 is a third-generation anaplastic lymphoma kinase (ALK) inhibitor independently developed by TargetRx. It is a potent and highly selective small molecule inhibitor that targets ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases (RTKs). This inhibitor holds significant therapeutic potential for ALK/ROS1 fusion gene-positive non-small cell lung cancer (NSCLC) patients, especially those with multiple ALK-resistant mutations, including G1202R. In preclinical studies and a Phase 1 clinical trial, TGRX-326 demonstrated robust anti-tumor activity and a favorable safety profile. Moreover, the molecule effectively crosses the blood-brain barrier, exhibiting exceptional efficacy in NSCLC patients with brain metastases. Dr. Renhong Tang, Chairman of Simcere Zaiming, said, "We are pleased to collaborate with TargetRx on novel dual-targeted therapy for lung cancer, a major malignancy that Simcere Zaiming strategically focuses on. This partnership will further enhance our innovative product portfolio. ALK/ROS1 fusion is a critical genetic mutation in non-small cell lung cancer. The advancement of targeted therapies has significantly improved survival rates for these patients. However, there remains a substantial need for new treatments with better efficacy and the ability to overcome drug resistance. We look forward to working closely with TargetRx to provide Chinese lung cancer patients with more effective treatment options as soon as possible." Dr. Yihan Wang, Chairman of TargetRx, said, "TGRX-326 is a potentially best-in-class novel anti-tumor molecule independently developed by TargetRx. It is a third-generation ALK inhibitor in late-stage clinical development which may bring a better option for patients. We believe that with the support of Simcere Zaiming, we will be able to bring this product quickly to the market. TargetRx aims to continuously deliver innovative therapies that will transform the lives of cancer patients." About Simcere Zaiming Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, Enweida®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in cancer therapeutics. About TargetRx TargetRx is a clinical stage, high-tech pharmaceutical R&D company focused on developing next-generation targeted therapies for cancer patients, particularly those who are resistant or refractory to current treatments. TargetRx has developed a series of cutting-edge and efficient small molecule drug discovery platforms, which combine innovative research and development capabilities for drug design, screening, evaluation and optimization. Since its establishment, TargetRx has been granted over 170 patents from authorities in China, the US, Europe, Japan and other regions. Several potential best-in-class compounds are at different stages of multi-national clinical trials. SOURCE Simcere Pharmaceutical Group Limited

Phase 1License out/in

100 Deals associated with Shenzhen TargetRx, Inc.

100 Translational Medicine associated with Shenzhen TargetRx, Inc.

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Pipeline Snapshot as of 23 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

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Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Deulorlatinib ( ALK x ROS1 )	ALK positive Non-Small Cell Lung Cancer More	Phase 3
TGRX-814 ( Bcl-2 x Bcl-xl )	Adult Acute Lymphocytic Leukemia More	Phase 2 Clinical
TGRX-678 ( Bcr-Abl T315I )	Aggressive-Phase Chronic Myelocytic Leukemia More	Phase 2
TGRX-1942 ( PTK7 )	Advanced Malignant Solid Neoplasm More	Phase 1
Bruton's tyrosine kinase inhibitor(TargetRx) ( BTK )	Lymphoma More	Preclinical

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