Lepu Biopharma plans to offer 126,876,000H shares (subject to the Over-allotment Option), of which 114,188,000 H shares will be International Offer Shares (subject to reallocation and the Over-allotment Option), representing 90% of the initial offer shares; the remaining 12,688,000 H shares will be Hong Kong Offer Shares (subject to reallocation), representing 10% of the initial offer shares. Offer Price is between HK$6.87 and HK$7.38 per Offer H Share. Lepu Biopharma will open for Hong Kong Public Offering in Hong Kong at 9 a.m., 10 February 2022 (Thursday), and close at 12:00 noon, 15 February 2022 (Tuesday). Dealings in shares of Lepu Biopharma on the Main Board of the Hong Kong Stock Exchange is expected to commence on 23 February 2022 (Wednesday). The shares will be traded in board lot of 1,000 shares each. The Company's stock code is 2157.
-- China International Capital Corporation Hong Kong Securities Limited and Morgan Stanley Asia Limited are the Joint Sponsors and Joint Global Coordinators.
-- China International Capital Corporation Hong Kong Securities Limited, Morgan Stanley Asia Limited (exclusively for Hong Kong Offer Shares), Morgan Stanley & Co. International plc (exclusively for International Offer Shares), Haitong International Securities Company Limited, Huatai Financial Holdings (Hong Kong) Limited, China Galaxy International Securities (Hong Kong) Co., Limited and Valuable Capital Ltd. are the Joint Bookrunners.
-- China International Capital Corporation Hong Kong Securities Limited, Morgan Stanley Asia Limited (exclusively for Hong Kong Offer Shares), Morgan Stanley & Co. International plc (exclusively for International Offer Shares), Haitong International Securities Company Limited, Huatai Financial Holdings (Hong Kong) Limited, China Galaxy International Securities (Hong Kong) Co., Limited, Valuable Capital Ltd. and Tiger Brokers (HK) Global Limited (exclusively for International Offer Shares) are the Joint Lead Managers.
Lepu Biopharma was incorporated in 2018 and is a biopharmaceutical company focusing on oncology therapeutics. The Company has designed pipeline with a range of oncology products. As of the Latest Practicable Date, the Company had pipeline including eight clinical-stage drug candidates, three pre-clinical drug candidates and three clinical-stage combination therapies of the candidates in the pipeline. The product pipeline of Lepu Biopharma features broad-spectrum anti-tumor drugs, including primarily the anti-PD-1 antibody candidate, as the backbone, and a dual focus on ADC and oncolytic virus drug candidates, maximizing synergies in both drug efficacy and commercialization and enabling company to expand indications and addressable market. The Company takes Anti-PD-1 antibody candidate as the cornerstone of its immunotherapies, advances the research and development of related products. The Company filed an NDA of HX008 in melanoma in June 2021 with the NMPA, and filed an NDA of HX008 in MSI-H/dMMR solid tumors in October 2021 with the NMPA. In addition, the Company focus on the development of innovative drugs including ADC and oncolytic virus. According to Frost & Sullivan, the Company house the leading ADC drug candidate pipeline in China in terms of the number of clinical-stage ADC drug candidates. The comprehensive ADC and oncolytic virus pipeline of company creates synergies and maximizes its competitive strength in commercialization. As of the Latest Practicable Date, company had initiated 28 clinical trials, among which three had entered registration trial phase and two were ongoing in the U.S.
Core Product with Encouraging Clinical Trial Results and Advance R&D Smoothly
The major pipeline assets of Lepu Biopharma consist of four core products, namely, MRG003, MRG002, HX008 and LP002, and three key clinical-stage drug candidates.
Among core products, MRG003 and MRG002 are ADC drug candidates, MRG003 is the most advanced EGFR-targeted ADC in clinical-stage development in China and has the potential to seize market opportunities. The Company is conducting Phase II clinical trials of MRG003 in recurrent or metastatic advanced HNSCC, advanced NSCLC, BTC and NPC in China, and expects to initiate clinical trials in recurrent or metastatic advanced HNSCC in the U.S. and expand MRG003 indications based on the clinical data obtained, further expanding the overall addressable market with the aim of achieving international commercialization with MRG003.
MRG002 is an innovative HER2-targeted ADC. Company's pre-clinical studies revealed better efficacy as compared to T-DM1 (trastuzumab emtansine) in multiple Herceptin-resistant HER2 over- and low-expressing PDX models of the gastric cancer and breast cancer. The Company had initiated Phase II clinical trials of MRG002 in HER2 low-expressing and over-expressing breast cancer, UC (urothelial cancer) and HER2 over-expressing BTC. For HER2 over-expressing breast cancer, the Company had obtained approval from the NMPA of registration trial.
HX008 and LP002 are anti-PD-1/anti-PD-L1 drug candidates, HX008 is a humanized antagonist mAb to human PD-1, which demonstrated efficacy and a good safety profile in the completed Phase Ia clinical trial in solid tumors. As of the Latest Practicable Date, the Company was also in the process of conducting a Phase II clinical trial of HX008 in NMIBC and a Phase III clinical trial of HX008 in the second-line gastric cancer. LP002 is a humanized mAb against PD-L1, which has shown a favorable safety profile in a Phase Ia clinical study in advanced solid tumors. Lepu Biopharma are in the process of a cohort expansion trial in advanced digestive system cancer and have completed patient enrollment and entered the follow-up period for Phase II clinical trials in ES-SCLC in China.
Core Technology Platforms to Buttress Products
Lepu Biopharma has demonstrated capabilities in the development of innovative drugs spanning across early-stage molecular target identification and validation, pre-clinical development and CMC development. The Company has three synergistic core technology platforms around its pipeline specializing in ADC technology, antibody discovery and advanced process and analytical development.
The Company has fully integrated ADC technology platform covering discovery, process and analytical development and manufacturing, is able to design and create new molecules with innovative mechanisms and utilize cutting-edge technology, such as GlycoConnect(TM) site-specific conjugation technology. It has, among others, cutting-edge ADC technologies including sophisticated DAR control technology, advanced ADC conjugation technology, identification and validation of early-stage molecular targets, ADC process development and a well-established quality analysis system.
The Company has constructed a full human naive antibody library of 1011 scale, the platform reduces the reliance on animal immune systems to produce antibodies, and significantly shorten the development period of innovative drug candidates to four to six weeks compared to the traditional hybridoma technology. The Company has also constructed a trispecific antibody T cell engager platform by utilizing protein binding domains, such as nanobodies and scFv, to augment T cells' response to solid tumors.
Lepu Biophamra has an advanced process and analytical development platform for antibodies and ADCs. The Company has implemented a comprehensive set of quality analysis methods and inspection technology to assess and control the product quality in the course of process and analytical development and production to fulfill the requirements for registration, in order to ensure a standardized process and analytical development and quality control.
Intellectual Property Promotes the Sustainable Development of Drugs
Implement Manufacturing and Commercialization Layout
Intellectual property is pivotal to the sustainable development and commercialization of drugs, the Company endeavors to ensure global full-life-cycle IP protection for drug candidates. As of the Latest Practicable Date, Company had 11 issued patents in China, 20 in the U.S., nine in Japan, seven in the European Union and one in each of South Korea, Australia, Chile, India, Colombia, Indonesia, New Zealand and Israel, and 74 pending patent applications, consisting of 15 in Mainland China and 59 in overseas jurisdictions such as the U.S., Japan, India, South Korea, Australia, Israel, and the European Union. Our patent portfolio spans across mAb structure, targeted epitope, CMC, usage, biopharmaceutical formulation and indications.
While Lepu Biopharma advancing its drug candidates, it has mapped out and is implementing the manufacturing and commercialization strategies. Company commenced the operation of a 2,000L GMP-compliant antibody production line in Beijing in 2019 in support of clinical trials for the antibody products, it is building a production line for oncolytic virus drugs in Beijing with a designed capacity of 200L, as well as a biologics manufacturing center in Shanghai Biotech Park, including production line with a designed capacity of 12,000L initially, coupled with laboratories and manufacturing facilities, and one production line with capacity of 6,000L under construction. The Company is building marketing forces in China and seeking partnership opportunities to support international expansion and commercialization.
Expedite Innovative Drugs Development
Advance Pipeline and Technology Platforms Construction
Lepu Biopharma strives to expedites immune checkpoint inhibitor therapy development, aims to achieve expedited and adequate market coverage of HX008 through both medical institutions and direct-to-patients distribution channels by leveraging the broad spectrum of indications covered by MSI-H/dMMR solid tumors. The Company expects to establish effective sales channels and strengthen the commercialization capabilities through the commercialization of HX008, which would also benefit its efforts to commercialize other drug candidates. The Company also plans to seek strategic partnerships with preeminent pharmaceutical companies internationally to maximize the clinical and commercial value of its immune checkpoint inhibitors.
Lepu Biopharma advances the clinical development of its candidates including ADC candidates, oncolytic virus candidates and combination therapies, plans to stay focused on the development of innovative products, create a pipeline for novel therapies, design and develop innovative products and build advanced technology platforms. In addition, the Company is committed to strengthening its overseas business development of pipeline, enhancing the brand awareness and continuously exploring the commercial value of its products and technology in the international market, and will make efforts to pursue out-licensing partnership opportunities in overseas markets. Furthermore, to meet the commercialization demand, the Company will expand GMP-compliant manufacturing facilities to increase capacity and enhance product quality.
The Founder, Chairman and Executive Director of Lepu Biopharma Co., Ltd. Dr. Pu Zhongjie said, "Since our inception, Lepu Biopharma focuses on the development of innovative drugs, the design and well-establishment of pipeline, we have established an integrated end-to-end platform across drug discovery, clinical development and CMC and GMP-compliant manufacturing. As an innovation-driven biopharmaceutical company leveraging an internationally integrated research and development system, we are committed to fulfilling current medical needs. Lepu Biopharma has solid R&D capabilities, advanced development platforms and comprehensive pipeline, we will the hold future trend and of the whole industry, use our competitive strengths to keep Lepu Biopharma's status in the market and maxmize the created value for shareholders and investors."
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