US STOCKS
FUNDS
FX & CRYPTO
SH/SZ-HK
HK STOCKS
 
 
 
 
 
 
To-be Listed
Name
/
Code
Industry Offer Price Lot Size Entry Fee Closing Date
Grey Market Date
Listing Date
Hesai-W
02525.HK
Electrical Components & Equipment N/A 20 4,605.99 2025/09/11 2025/09/15 2025/09/16
160 Health
02656.HK
Health Care Supplies 11.89-14.86 250 3,752.47 2025/09/12 2025/09/16 2025/09/17
GenFleet-B
02595.HK
Biotechnology - Pharmaceuticals 20.39 200 4,119.13 2025/09/16 2025/09/18 2025/09/19
Summary
Founded in 2017, we are a biopharmaceutical company focused on developing novel treatment options in the fields of oncology, covering different lines of treatments of multiple solid tumors, as well as autoimmune and inflammatory diseases. As of the Latest Practicable Date, we had established a product pipeline consisting of eight product candidates with five under clinical development, including two Core Products — GFH925 and GFH375.

GFH925 (fulzerasib, marketed under the brand name Dupert), an in-house discovered new drug, has been approved for commercialization in China for the treatment of advanced non-small cell lung cancer (“NSCLC”), and it was China’s first and globally the third approved selective inhibitor of Kirsten rat sarcoma (“KRAS”) G12C. We retain all rights, including conducting R&D, manufacturing and commercialization of GFH925 globally outside of the Greater China, and we have out-licensed all rights related to GFH925 in the Greater China. We are currently conducting Phase II stage of KORCUS trial in the EU for GFH925/cetuximab combination therapy as a first-line treatment of NSCLC. GFH375 is an orally bioavailable small molecule inhibitor of KRAS G12D. We have initiated the Phase II part of a Phase I/II clinical trial in patients with advanced solid tumors harboring the KRAS G12D mutation in China. In addition to our Core Products, we aim to further diversify our pipeline portfolio beyond our RAS matrix, as exemplified by GFS202A, an in-house developed bispecific antibody targeting GDF15 and IL-6. Our pipeline also includes GFH312, an in-house developed potent small molecule that targets receptor interacting serine/threonine-protein kinase 1 (“RIPK1”) and inhibits its kinase activity. We have obtained NMPA’s approval to conduct a Phase II clinical of GFH312 for the treatment of primary biliary cholangitis (“PBC”) in China. Our diversified pipeline portfolio is a natural outcome of our established research and development platforms spanning target discovery, molecular discovery and evaluation, translational science and global clinical development, augmented by our expertise in key chemistry, manufacturing and controls (“CMC”) aspects including formulation research and quality analysis.

WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OUR CORE PRODUCTS.

CORE PRODUCTS

Overview of GFH925

Our Core Product GFH925, also known as fulzerasib and marketed in China under the brand name Dupert, is an in-house discovered, small molecule selective inhibitor of the KRAS G12C protein. Having received the NDA approval from the NMPA as a Class 1 new drug in August 2024 for the second or later-line treatment of NSCLC harboring the KRAS G12C mutation, it is China’s first and globally the third approved selective inhibitor of KRAS G12C. GFH925 received the breakthrough therapy designation (“BTD”) for advanced NSCLC and was conferred the priority review status by the NMPA, and received marketing approval in merely approximately three years after the NMPA cleared the IND approval in July 2021, underscoring its recognized competitive advantages over existing therapeutic options. GFH925 also received the BTD from the NMPA in May 2023 as a third-line treatment for advanced colorectal cancer (“CRC”) harboring the KRAS G12C mutation. We anticipate that GFH925 would qualify for negotiation for inclusion in 2026 National Reimbursement Drug List (“NRDL”), because GFH925 is China’s first and globally the third approved selective inhibitor of KRAS G12C and KRAS G12C-mutant NSCLC has substantial patient population in China. With over 15 years of patent term remaining for GFH925 as of the Latest Practicable Date, we anticipate to realize commercial returns from GFH925 to fuel our future growth.

Clinical results of GFH925 as a monotherapy have demonstrated promising safety and efficacy profile. For instance, in the single arm registrational Phase II clinical trial that supported the NDA approval, GFH925 was generally well tolerated and demonstrated encouraging antitumor activity in NSCLC patients harboring the KRAS G12C mutation. According to its approved label in China, as of the data cut-off date of December 13, 2023, the confirmed objective response rate (“ORR”) was 49.1%, and the disease control rate (“DCR”) was 90.5% in 116 patients. The median progression-free survival (“PFS”) was 9.7 months, and the median overall survival (“OS”) was 13.3 months. The median duration of response (“DoR”) was not reached. GFH925 also demonstrated a favorable overall safety profile with absence of Grade 3 or above QT interval prolongation or renal impairment observed in FDA-approved KRAS G12C inhibitors based on reported data, which are critical measurements for cardiac safety and drug clearance. For details, see “Business — Core Product GFH925: A Small Molecule Inhibitor of KRAS G12C — Summary of Clinical Trials.”

We are advancing overseas clinical development of GFH925 to unleash its therapeutic potential, including a Phase Ib/II clinical trial for the first-line treatment of advanced NSCLC as a combination therapy with cetuximab, an antibody drug targeting epidermal growth factor receptor (“EGFR”), in countries within the EMA jurisdiction. As EGFR is situated upstream of RAS proteins in the signaling pathway and involved in switching on RAS proteins, we reasoned that the combination therapy may achieve synergistic effects in damping the EGFR-RAS pathway, which is critical for cell growth. We independently developed GFH925/cetuximab combination therapy and its clinical trial design without any involvement or contribution from our partner in China in the study design, protocol development, or trial operations. The combination therapy is among the first of its kind to co-target KRAS G12C and EGFR in terms of the clinical development status. We have been conducting the GFH925/cetuximab combination trial (“KROCUS Trial”) independently in Europe and have not relied on or used, and does not intend to rely on or use, any data generated from the clinical studies of the same combination therapy in China. Apart from incorporating certain publicly available data or authorized information (authorized for use in a clinical trial application under the Innovent Agreement) on the monotherapies of GFH925 and cetuximab (including the dosage, safety and efficacy data of the Phase I clinical trial of GFH925 in China conducted by Innvonent, as well as the chemical nature, approved indication and dosage regime of cetuximab) in our ex-China IND applications — as required under the EMA and FDA regulatory frameworks for combination studies — we have not relied on any research and development activities conducted by Innovent or other third parties. In addition, in advancing the R&D of GFH925 in ex-Greater China regions, we have not relied on or used — and do not intend to rely on or use — any data generated from Innovent’s or other third parties’ clinical studies of the same combination therapy in China.

Interim results from the Phase Ib/II clinical trial in Europe provide preliminary evidence of the synergetic effect of GFH925 and cetuximab, which leads to promising antitumor efficacy compared to GFH925 as a monotherapy or to the current treatment regimens with chemotherapy drugs or PD-(L)1 drugs alone or in combination with chemotherapy. Following completion of the Phase Ib safety confirmation trial and pursuant to the clinical trial protocol, all data review team members, consisting of principal investigators, the CRO medical monitor and we as the clinical trial sponsor, collectively reviewed the clinical data from the Phase Ib trial, and collectively confirmed that the selected dosage of GFH925 is safe, and collectively agreed that the Phase II trial may proceed. The primary endpoints of the Phase Ib were reached and safety confirmation of Phase Ib trial was completed by the data review team, as required by the clinical trial protocol. We anticipate completing the Phase II trial in the fourth quarter of 2025. We plan to leverage the clinical results in Europe to apply for a Phase III clinical trial in the United States and Europe to evaluate the safety and efficacy of the GFH925/cetuximab combination therapy. We had a pre-IND meeting with the FDA in February 2025 regarding our planned IND application for a Phase III clinical trial. Once approved, we plan to initiate the Phase III clinical trial in the fourth quarter of 2025.

NSCLC presents large addressable markets, and we view GFH925 as well-positioned to capture the considerable market opportunities. However, we may face uncertainties in clinical trial development which are subject to a variety of factors, including satisfactory safety and efficacy results from clinical trials, successful enrollment of patients, performance of CROs and other parties involved in clinical trial development and others. For more details, please see “Risk Factors — Risks Relating to the Development, Clinical Trials and Regulatory Approval of Our Pipeline Products — Our business and financial prospects depend substantially on the success of our pipeline products. If we are not able to successfully complete clinical development, obtain regulatory approval and commercialize our pipeline products, including our Core Products, or experience delays in doing so, our business prospects could be adversely affected.”



Source: GenFleet-B (02595) Prospectus (IPO Date : 2025/09/11)
Listing Market MAIN
Industry Biotechnology - Pharmaceuticals
Background H Shares
Major Business Area N/A
Corporate Information
No related information.
 
SITEMAP
Email: support@aastocks.com
AASTOCKS.COM LIMITED (阿斯達克網絡信息有限公司) All rights reserved.
Disclaimer
You expressly agree that the use of this app/website is at your sole risk.

AASTOCKS.com Limited, HKEx Information Services Limited, China Investment Information Services Limited, Shenzhen Securities Information Co. Ltd, Nasdaq, Inc., their respective holding companies and/or any subsidiaries of such holding companies, their Sources and/or other third party data provider(s) endeavour to ensure the accuracy and reliability of the Information provided but do not guarantee its accuracy or reliability and accept no liability (whether in tort or contract or otherwise) for any loss or damage arising from any inaccuracies or omissions.

Neither AASTOCKS.com Limited, HKEx Information Services Limited, China Investment Information Services Limited, Shenzhen Securities Information Co.Ltd., Nasdaq, Inc. nor their respective holding companies and/or any subsidiaries of such holding companies nor their Sources and/or other third party data provider(s) make any express or implied offers, representations or warranties (including, without limitation, any warranty or merchantability or fitness for a particular purpose or use) regarding the Information.

Neither AASTOCKS.com Limited, HKEx Information Services Limited, China Investment Information Services Limited, Shenzhen Securities Information Co. Ltd., Nasdaq, Inc. nor their respective holding companies and/or any subsidiaries of such holding companies nor their Sources and/or other third party data provider(s) will be liable to any Subscriber or any other party for any interruption, inaccuracy, error, or omission, regardless of cause, in the Information or for any damages (whether direct or indirect, consequential, punitive, or exemplary) resulting from its use by any party.

AASTOCKS.com Limited shall not be liable for any failure or delay in performance of its obligations under this Disclaimer because of circumstances beyond its reasonable control, including but without limitation, acts of God, typhoons, rainstorms, other natural disasters, government restrictions, strikes, wars, virus outbreak, network failures or telecommunications failures.

Morningstar Disclaimer: Copyright © 2020 Morningstar, Inc. All Rights Reserved. The information, data, analyses and opinions ("Information") contained herein: (1) include the proprietary information of Morningstar and Morningstar’s third party licensors; (2) may not be copied or redistributed except as specifically authorised; (3) do not constitute investment advice; (4) are provided solely for informational purposes; and (5) are not warranted to be complete, accurate or timely. Morningstar is not responsible for any trading decisions, damages or other losses related to the Information or its use. Please verify all of the Information before using it and don’t make any investment decision except upon the advice of a professional financial adviser. Past performance is no guarantee of future results. The value and income derived from investments may go down as well as up.

The information and contents contained in this app/website are based on the analyses and interpretations of publicly available information obtained from sources believed to be reliable. Such analyses and information have not been independently verified and AASTOCKS.com Limited makes no guarantees to their accuracy, completeness, timeliness or correctness.

The information, financial market data, quotes, charts, statistics, exchange rate, news, research, analysis, buy and sell ratings, Education Center and other information on this app/website should be used as references only at your own discretion. Prior to the execution of a security or any other trade based upon the Information, you are advised to consult independent professional advice to verify pricing information or to obtain more detailed market information. AASTOCKS.com Limited is not soliciting any subscriber or app/website visitor to execute any trade. Any trades executed following the said information, commentaries and/or buy/sell ratings on this app/website are taken at your own risk for your own account.

AASTOCKS.com Limited provides the information and services on an "AS IS" basis. The information and contents on this app/website are subject to change without notice. AASTOCKS.com Limited reserves the right, in its sole discretion but without any obligation, to make improvements to, or correct any error or omissions in any portion of this app/website at any time.

The subscriber or app/website visitor agrees not to reproduce, retransmit, disseminate, distribute, broadcast, publish, circulate, sell or commercially exploit the information and contents on this app/website in any manner without the express written consent of AASTOCKS.com Limited.

Investment involves risk. You may make use of the Education Center of this website for academic reference purposes at your own discretion. AASTOCKS.com Limited cannot and does not give any assurance that the present or future buy/sell commentaries and signals on this app/website will be profitable. AASTOCKS.com Limited cannot guarantee, and the subscriber or app/website visitor should not assume, that the future performance will equal past performance.

AASTOCKS.com Limited may point to other sites that may be of interest to the subscriber or app/website visitor but for which AASTOCKS.com Limited has no responsibility and only provides this as a service to the subscriber or app/website visitor.

AASTOCKS.com Limited does not represent or endorse the accuracy or reliability of any information, advertisements or contents contained on, distributed through, or linked, downloaded or accessed from any of the services on this app/website. AASTOCKS.com Limited cannot and does not guarantee the quality or reliability of any products or information purchased or obtained by you as a result of an advertisement or any other information displayed on this app/website.

AATV is a video platform owned by AASTOCKS.com Limited.

You acknowledge that: (i) AATV is provided for information purposes only and, in particular, is not intended for trading purposes; (ii) AATV does not and none of the information contained in its program constitutes a solicitation, offer, opinion, or recommendation by us to buy or sell any security, or to provide legal, tax, accounting, or investment advice or services whether or not regarding the profitability or suitability of any security or investment; and (iii) AATV is not intended for use by, or distribution to, any person or entity in any jurisdiction or country where such use or distribution would be contrary to law or regulation.

The financial analysis or opinion expressed in the AATV programs is for reference and discussion only, and does not represent AASTOCKS.com Limited. Investors must make their own investment decisions based on their own investment objectives and financial situation. AASTOCKS.com Limited shall not, directly or indirectly, be liable, in any way, to you or any other person for any: (i) inaccuracies or errors in or omissions from AATV including, but not limited to, quotes and financial data; (ii) delays, errors, or interruptions in the transmission or delivery of AATV; or (iii) loss or damage arising therefrom or occasioned thereby, or by any reason of nonperformance.

AASTOCKS.com Limited reserves the right to change this Disclaimer at any time by posting changes online at this app/website. You are responsible for reviewing regularly information posted therein to obtain timely notice of such changes. Your continued use of this app / website after changes are posted constitutes your acceptance of this Agreement as modified by the posted changes.

The disclaimer herein shall be governed by the law of the Hong Kong Special Administrative Region of the People's Republic of China ("Hong Kong") and you agree to submit to the exclusive jurisdiction of the Hong Kong courts.

In the event of any discrepancy between the Chinese and English versions, the English version shall prevail.

Last updated on 6 January 2023.