IPO Spotlight: 8 Biopharmaceutical Companies Filed for Hong Kong Listing in 2024 – Profiles and Pipeline Overview

May 13, 2024 15:49 CST Updated 15:49

Shanghai Cell Therapy Group

Cell Health Medical Products and Service Provider

B&K CORPORATION

Biological Macromolecule Drug Developer

VISEN

Endocrine-related Disease Treatment Drug Developer

PegBio

Developer of Innovative Therapies for Chronic Diseases

Health Guard

Recombinant Protein Drug Developer

In the pharmaceutical industry, there has long been a "double ten rule," which means it takes 10 years and costs 1 billion US dollars to bring a drug from research and development to commercialization. In other words, apart from focusing on R&D, securing funding is also a crucial task. And...In the case of a phased tightening of the A-share IPO pace, many pharmaceutical companies have turned their attentionTurned to the Hong Kong Stock Exchange, this article statistically analyzedEight Biopharmaceutical Companies Listed on the Hong Kong Stock Exchange Since 2024The following are the specific situations of these companies.

1. Shanghai Cell Therapy Group Co., Ltd.

April 30According to the Hong Kong Stock Exchange's official website, Shanghai Cell Therapy Group Co., Ltd. (hereinafter referred to as "Shanghai Cell Therapy Group") has submitted an application for listing on the Hong Kong Stock Exchange. According to the prospectus, Shanghai Cell Therapy Group isChina's First and Only Company Covering the Entire Value Chain of Cellular Healthcare, Business CoverageCell Storage, Tumor Treatment, Cell-based Drugs, and Cell Recharging。

In 2013, Shanghai Cell Therapy Group was established, focusing on the research and development of cell-based drugs. In 2015, the company began offering cell storage services, including immune cell and stem cell storage. By 2020, the company had expanded its business into the field of oncology medical services. In 2023, it further launched cell empowerment products. Currently, the company's main sources of revenue are cell storage and related services.

Among them, in the research and development of cellular drugs, the company has identified andDeveloped 7 products under researchBZDS1901 is the world's first CAR-T cell drug armored with anti-PD-1 nanobody focused on the treatment of solid tumors. Currently, no CAR-T cell therapy products for solid tumors have been approved globally. BZDS1901 has received IND approval from the National Medical Products Administration (NMPA) for Phase I and II clinical trials to treat mesothelin-positive solid tumors and has obtained orphan drug designation from the FDA for malignant mesothelioma.

2. B&K CORPORATION LIMITED

April 29B&K CORPORATION has submitted its prospectus to the Hong Kong Stock Exchange, planning to list on the Main Board of Hong Kong. This is the company's first submission for an IPO application, with Huatai International and CITIC Securities acting as joint sponsors.

In 2012, B&K CORPORATION was established, formerly known as Beijing Zhonghong Saici Biotechnology Co., Ltd. On April 1, 2024, it was renamed for the third time to its current name, B&K CORPORATION. The company focuses on indications with unmet medical needs and significant market opportunities.Protein drugs, with the main focus on the discovery, development, and commercialization of multifunctional therapies for wound healing., currently focusing on the development of Platelet-Derived Growth Factor ("PDGF") drugs.

Since its establishment, B&K CORPORATION has raised over 400 million yuan in financing from investors including CDH Investments and Qingdao Hi-Tech. After completing the final round of financing before the IPO in May 2023, its valuation exceeded 3.3 billion yuan. Currently, the company has not yet achieved commercialization. In 2023, the company's other income was 474,000 yuan, with a net loss of 105 million yuan and R&D expenditure of 39.915 million yuan.

As of the end of April this year,B&K CORPORATION's pipeline includes 10 candidate products.Among them, there are 7 PDGF candidate products covering a wide range of wound healing indications, including burns, diabetic foot, fresh wounds, pressure ulcers, radiation ulcers, dry eye syndrome, corneal injury, sun dermatitis, alopecia, hemorrhoids, and gastric ulcers; 1 mRNA candidate product targeting solid tumors; and 2 ASO candidate products, respectively for glioblastoma and triple-negative breast cancer. The core products are Pro-101-1 and Pro-101-2, which are recombinant human platelet-derived growth factor-BB ("rhPDGF–BB") drugs.

3. VISEN

March 21`, VISEN Pharmaceuticals (Shanghai) Co., Ltd. submitted an IPO application to the Main Board of the Hong Kong Stock Exchange. This is already its`Third Time Submitting to the Hong Kong Stock ExchangePreviously, the company had submitted listing applications to the Hong Kong Stock Exchange on November 17, 2022, and August 16, 2023.

VISEN Pharmaceuticals (Shanghai) Co., Ltd. was founded in 2018 and is an innovative biopharmaceutical company in the late stage of development with products nearing commercialization.Focus on Developing Next-Generation Endocrine Therapies, focusing on addressing the large unmet medical needs in relevant regions while benefiting from favorable healthcare policies.Innovative and potentially best-in-class and/or first-in-class treatment solutions for specific endocrine diseases。

In terms of product pipeline,VISEN currently has 3 drug candidates., respectivelyLonapegsomatropin, TransCon CNP, and ParoparatideAmong them, Lonapegsomatropin is the first of its kind. It received FDA and EMA approval for market release in 2021 and 2022, respectively, as a long-acting growth hormone (LAGH) for treating pediatric growth hormone deficiency (PGHD). In March this year, the drug's marketing application was accepted in China. The other two products have also entered the late-stage clinical trial phase globally. Notably, all three products were introduced from Ascendis.

4. PegBio Medical (Suzhou) Co., Ltd.

February 23PegBio Co., Ltd. submitted its prospectus to the Hong Kong Stock Exchange for a proposed IPO on the Main Board of Hong Kong. Previously, the company had submitted an application for listing on the STAR Market to the China Securities Regulatory Commission in August 2021 and received two rounds of feedback, but voluntarily withdrew its A-share listing application in April 2022.

PegBio was founded in 2008 and is a company focused onIndependent Research and Development of Innovative Therapies for Chronic DiseasesBiotechnology company,Focus on the Field of Metabolic DisordersAccording to incomplete statistics, PegBio has completed 9 rounds of financing, accumulating over 1.3 billion yuan from Legend Capital, Junlian Capital, Yunfeng Fund, Yuansheng Ventures, CCB International, and others. After the final round (F+ round) of financing, its valuation reached approximately 4 billion yuan.

Since its establishment, PegBio has not commercialized any products, and the company's revenue to date is zero. In terms of the product pipeline,The company has independently developed 1 core product and 5 other candidate products., with indications including common chronic and metabolic diseases such as type 2 diabetes (T2DM), obesity, non-alcoholic steatohepatitis (NASH), opioid-induced constipation (OIC), and congenital hyperinsulinism.

Among them, PegBioCore Product PB-119A self-developed, near-commercialization long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used as a first-line treatment for T2DM and obesity, has demonstrated comprehensive benefits in blood glucose control, cardiovascular health, and effective weight management in multiple clinical trials. The new drug application for the treatment of T2DM in China was accepted by the National Medical Products Administration in September 2023. Additionally, the company’s clinical-stage candidate drugs include key products PB-718, PB-1902, and PB-722, along with preclinical-stage products PB-2301 and PB-2309.

5. Sunho Biologics, Inc.

February 9Sunho Biologics, Inc. has submitted its listing application to the Hong Kong Stock Exchange (HKEX) for a proposed main board IPO, with CICC acting as the sole sponsor. Previously, the company had first filed for an HKEX listing in August 2023, and this marks its second attempt at the Hong Kong stock market. It is reported that the company has passed the HKEX listing hearing on April 15.

Sunho Biologics, Inc. was founded in 2018 and is dedicated to the discovery, development, and commercialization ofInnovative Biologics for Treating Cancer and Autoimmune DiseasesClinical-stage biopharmaceutical company.

Currently,The company has identified and developed 9 pipeline products., six of which are in the clinical stage and three are in the preclinical stage. Among them, the company has three core products, including two antibody cytokines, IAP0971 and IAE0972, and one ADCC-enhanced antibody, IAH0968. The former two are developed based on the company's AICTM platform, while the latter is developed based on the company's ADCC-enhanced antibody platform (AEATM platform). In addition, the other six candidate products under development include clinical-stage products IBB0979, IBC0966, and IBD0333, as well as preclinical-stage products IAN0982, ISH0988, and ISH0613.

6. Biostar

January 29Biostar has submitted its prospectus to the Hong Kong Stock Exchange, planning for an IPO in Hong Kong, with CCB International and CSC Financial International as joint sponsors. Previously, the company applied for listing on the STAR Market in June 2022, responded to two rounds of inquiry letters, and withdrew the application in May 2023.

Biostar is aA global biopharmaceutical company driven by synthetic biology technology, dedicated to developing innovative oncology drugs.The company has successfully developed three core technology platforms focused on the research and development of new drugs based on microbial metabolites, and established a diversified product portfolio, includingA commercialized product and a pipeline consisting of 19 projects。

Among them, the company'sCore Product: Utidelone InjectionApproved for marketing by the National Medical Products Administration in 2021 for the treatment of recurrent or metastatic advanced breast cancer. As of the latest practicable date, Utidelone Injection is the only chemotherapy innovation drug developed and approved for marketing through synthetic biology technology, and also the only microtubule inhibitor with a novel molecular structure approved globally in the past decade. In addition, the company expects to obtain NDA approval in China for Utidelone Capsules for the treatment of advanced breast cancer by 2025, and NDA approval for Utidelone Injection for the treatment of advanced NSCLC and neoadjuvant treatment of breast cancer by 2026.

7. Beijing Health Guard Biotechnology, Inc.

January 29Health Guard has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities and CCB International as joint sponsors. Previously, the company was listed on the NEEQ in September 2015 and on the Beijing Stock Exchange in March 2023. If this Hong Kong listing is successful, Health Guard will become the first company in China to be listed on both the Beijing Stock Exchange and the Hong Kong Stock Exchange ("North + H").

Health Guard was founded in April 2008 and is a China-based clinical-stageVaccine Developer. The company ownsThe World's Richest Portfolio of HPV (Human Papillomavirus) Vaccines, including trivalent, nonavalent, pentavalent HPV vaccines and bivalent therapeutic HPV vaccine, but the company has no products on the market yet.

Specifically, the company's core products, including the trivalent HPV vaccine, the nonavalent HPV vaccine (for female indications), and the nonavalent HPV vaccine (for male indications), are all in Phase III clinical trials. The 15-valent HPV vaccine has entered Phase I clinical trials. Other R&D projects, such as the respiratory syncytial virus vaccine, the herpes zoster vaccine, the heptavalent norovirus vaccine, the quadrivalent hand-foot-mouth disease vaccine, the polio vaccine, and the bivalent therapeutic HPV vaccine, are all in the preclinical research stage.

Among them,The trivalent HPV vaccine is the company's product closest to commercialization.By the end of 2023, the vaccine has completed the 30-month visit and is currently conducting the 36-month visit, with the BLA application expected to be submitted by the end of 2024. In addition, the Phase III clinical trial for the company’s nine-valent HPV vaccine (female indication) has entered the case monitoring follow-up stage, during which the 30- and 36-month visits are being conducted. The company is expected to submit the BLA for the nine-valent HPV vaccine (female) in China and Indonesia in 2025 and the BLA for the nine-valent HPV vaccine (male) in 2027.

Currently, Health Guard has no commercialized vaccines, and the small amount of revenue obtained during the track record period came from the sale of test reagents used for research and development. The prospectus shows that in the past 2022 and the first nine months of 2023, Health Guard's operating income was RMB 1.901 million and RMB 1.601 million respectively, with corresponding net losses of RMB 293 million and RMB 225 million respectively.

8. Hangzhou Jiuyuan Gene Engineering Co., Ltd.

January 22Hangzhou Jiuyuan Gene Engineering Co., Ltd. has submitted its prospectus to the Hong Kong Stock Exchange, planning for an IPO in Hong Kong, with Huatai International as the sole sponsor.

Hangzhou Jiuyuan Gene Engineering Co., Ltd. was established in 1993 and mainly engages inResearch, Development, Production, and Commercialization of Biopharmaceuticals and Medical DevicesFocused on the four rapidly growing therapeutic areas of orthopedics, metabolic diseases, oncology, and hematology. As of January 15, 2024, Hangzhou Jiuyuan Gene Engineering Co., Ltd. has established a diversified product portfolio across these four therapeutic areas, which includes8 marketed products and more than 10 products under development。

Among them, the eight marketed products include one innovative drug-device combination in the fields of orthopedics, oncology, and hematology, two biologics, and five chemical drugs. The main products under research include JY29-2 (Ji You Tai®), JY29-2 (Ji Ke Qin®), and JY06 (Ji Xin Fen®).

In terms of performance, the company's revenue in 2021, 2022, and the first nine months of 2023 was RMB 1.307 billion, RMB 1.125 billion, and RMB 1.023 billion, respectively, with corresponding net profits of RMB 119 million, RMB 60 million, and RMB 111 million.

References:

[1] Shanghai Cell Therapy Group Files for HKEX Listing, Ranks First in Market Share of Immune Cell Storage. PharmaCube Invest. 2024-05-01.

[2] Shanghai Cell Therapy Group IPO: Cell Storage Costs Over Ten Thousand Yuan, Hoping 60% of the Public Can Afford It? Insight IPO. 2024-05-10.

[3] This Biotech IPO Features a "Resilient" Founder. Preliminary IPO Review. 2024-05-12.

[4] PegBio Co., Ltd.-B, from Suzhou, Jiangsu, submitted its IPO prospectus, planning to go public in Hong Kong, with CICC as the sole sponsor. Ryanben Capital. 2024-02-24.

[5] "Biostar" Files for Hong Kong Stock Exchange Listing for the First Time, Post-Investment Valuation at 4.5 Billion Yuan. Living Report. 2024-01-30.

[6] Biostar Continues to Incur Losses with a Sharp Decline in Gross Profit Margin: Sales Expenses Nearly 2 Billion in a Year, Also Became an Executed Party. Harbor Business Observer. 2024-03-04.

[7] Hangzhou Jiuyuan Gene Engineering Co., Ltd., from Hangzhou, Zhejiang, submitted its IPO prospectus for a planned listing in Hong Kong, with Huatai as the exclusive sponsor. Ryanben Capital, 2024-01-23.

[8] Sunho Biologics, Inc. Submits Again: Last-minute Shareholding Just Meets Requirements? Continuous Negative Cash Flow. Harbor Business Review. 2024-03-05.

[9] Sunho Biologics, Inc. - B, from Huzhou, Zhejiang, has passed the IPO hearing and may soon be listed in Hong Kong, exclusively sponsored by CICC. Ryanben Capital, 2024-04-16.

[10] Health Guard (833575): Core Product Enters Phase III Clinical Trials, Commercialization Imminent, Poised to Become One of the First HPV Vaccine Suppliers in China. Founder Securities Research. 2024-04-25.

[11] HKEX official website, prospectuses of various companies, etc.

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