Seven High-Profile Companies in the CGC Healthcare Ecosystem—Cloudbreak Pharma, Topcon Medical, Changfeng Pharma, Zhonghui Bio, United Imaging Intelligence, Boan Biologics, and Huiyu Pharma—File IPO Prospectuses Amid Major Clinical and Commercial Advances

Aug 08, 2024 16:50 CST Updated 16:50

TowardPi

High-end Ophthalmic Medical Device Developer

Santen Pharmaceutical (China)

Ophthalmic Pharmaceutical Manufacturer

▲ The twelfth issue of Gaoteka's industry research journal, "High·Insights," is about to be released. The core report of this issue, "Showcasing Great Application Potential Across Multiple Fields: The Rapid Rise of China’s Autoimmune Drug Market," provides an in-depth analysis of the R&D and technological trends of new autoimmune drugs in China.

RecentlyDay, Gortka Investment in Medical FieldMultiple members of the ecosystem, including Bokang Shi Yun, TowardPi Medical, Changfeng Pharmaceuticals, Zhonghui Biotech, United Imaging Intelligence, Boan Biotech, and Huiyu Pharma, have achieved several clinical and commercial advancements. As a long-term investor deeply engaged in China's healthcare industry, Gortica Investment remains firmly optimistic about the vast prospects of the healthcare sector. It will continue to identify innovative enterprises with genuine clinical needs and value, supporting the rapid growth of more healthcare companies in China.

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01
Bokang Vision Cloud: Collaboration with Santen Pharmaceutical on Pterygium‍‍‍‍‍‍‍‍
Innovative Drug CBT-001 Signs Licensing Agreement‍‍‍‍‍‍‍‍‍‍‍

On August 6, 2024, Cloudbreak Pharma Inc. (hereinafter referred to as "Cloudbreak"), an international clinical ophthalmic pharmaceutical company, and Santen Pharmaceutical Co., Ltd., a specialized ophthalmic enterprise, announced the signing of a licensing agreement. Cloudbreak has licensed its multi-kinase inhibitor CBT-001, which is under development for the treatment of pterygium, to Santen Pharmaceutical. The licensing agreement covers Southeast Asian regions including Japan, South Korea, Vietnam, Thailand, Malaysia, the Philippines, Singapore, and Indonesia. According to the agreement...Under the agreement terms, TowardPi has authorized Santen Pharmaceutical (China) Co., Ltd. to develop, manufacture, and commercialize the CBT-001 drug in the region. TowardPi will receive an upfront payment and milestone payments totaling up to 91 million US dollars. Additionally, TowardPi will also receive a double-digit percentage of the product's future net sales as royalties for this product.In January 2022, Bokang Vision Cloud secured a $130 million Series C financing round with investment from Gaocheng Capital.

CBT-001It is an emulsified nintedanib eye drop developed by Bokang Shi Yun, mainly used for the treatment of pterygium. Nintedanib is aMultikinase Inhibitor, mainly used forVEGF(Vascular Endothelial Growth Factor) Receptor,PDGF(Platelet-Derived Growth Factor) Receptor andFGF(Fibroblast Growth Factor) receptor, thereby inhibiting angiogenesis and fibrosis.CBT-001Completed in the United StatesIIPhase clinical trials are currently being conducted on a large scale in the United States, China, Australia, New Zealand, and India as part of a global multicenter study.IIIPhase Clinical Trial.CBT-001Can provide doctors and patients with a new treatment option for pterygium through eye drops, inhibiting the progression of the condition.

02‍
TowardPi: Partners with OCULUS Iberia‍‍‍‍‍‍‍‍
Officially Enter the Spanish Market‍‍‍‍‍‍‍‍‍‍‍

Recently, TowardPi, a leading enterprise in China's high-end ophthalmic medical device industry, announced a strategic partnership with OCULUS Iberia, officially introducing its domestically developed 100k-400k speed full-field scanning OCT/OCTA technology to the Spanish market. According to statistics, excluding trial and research installations, TowardPi’s formal orders and installations in Europe already cover many countries such as Italy, Switzerland, the Netherlands, Greece, Spain, and Turkey, with prices higher than classic mainstream brands from Europe, the U.S., and Japan. In June 2024, TowardPi secured 200 million yuan in D-round financing led by Gortune Investment.

OCULUS Iberia, established in 2011, is headquartered in Madrid, Spain. As a subsidiary of OCULUS, OCULUS Iberia offers a comprehensive product portfolio, including both self-manufactured and distributed products, with OCT being part of its offerings. Zhou Jian, Vice General Manager of International Affairs at TowardPi Medical, stated: "The addition of OCULUS Iberia marks Spain as the 18th country/region in Europe where TowardPi Medical has formally established a distribution network. It also represents one of TowardPi's key strategic bases in the European market. Additionally, it is TowardPi Medical’s 14th Spanish-speaking market globally."

03‍
Changfeng Pharmaceuticals: New Product in the Field of Chronic Obstructive Pulmonary Disease
Tiotropium Bromide Inhalation Powder Granted Clinical Tacit Approval‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, the new product Tiotropium Bromide Inhalation Powder independently developed by Changfeng Pharmaceutical Co., Ltd. has received clinical tacit approval from the National Medical Products Administration (NMPA). This product is mainly used for the treatment of Chronic Obstructive Pulmonary Disease (COPD), and can also be used for maintenance therapy of chronic bronchitis and emphysema with dyspnea, as well as prevention of acute exacerbations.

Chronic Obstructive Pulmonary Disease (COPD), commonly referred to as "slow obstructive lung disease," is a prevalent respiratory system disorder characterized by persistent airflow limitation. The high prevalence, significant disability and mortality rates, prolonged course of illness, extended treatment duration, and frequent hospitalizations during acute exacerbations make COPD one of the diseases with a substantial global healthcare burden. Tiotropium is a LAMA-class drug that inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine released from parasympathetic nerve endings by binding to muscarinic receptors on bronchial smooth muscle. After being administered via a specific inhalation device, tiotropium powder separates from the carrier particles and is delivered to the deep lung regions of the patient.

Changfeng Pharmaceuticals is committed to improving the quality of human life and health standards, with a goal of developing high-quality respiratory medications. The company focuses on researching, producing, and selling various types of inhalation drugs that are safe, effective, and accessible to the public. It has established a multi-formulation R&D pipeline covering inhalation aerosols, inhalation powders, inhalation liquid formulations, inhalation sprays, nasal sprays, and liposomes. The company aspires to become a well-known pharmaceutical enterprise in the industry, integrating R&D, industrialization, and commercialization of respiratory system drugs.

04‍
Zhonghui Bio: Quadrivalent Influenza Virus Subunit Vaccine (Adjuvanted)‍
IND Application Approved‍‍‍‍‍‍‍‍‍‍

Recently, Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. and its subsidiary YiHui Biotechnology (Shanghai) Co., Ltd. jointly submitted an IND application for a Class 1 new drug, "Tetra-valent Influenza Virus Subunit Vaccine (Adjuvanted)," which has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.‍

The "Quadrivalent Influenza Subunit Vaccine (Adjuvanted)" that has been accepted for review this time is the first adjuvanted influenza vaccine in China designed to protect people aged 65 and above from four strains of seasonal influenza viruses. It utilizes subunit influenza antigens and a new type of adjuvant independently developed by Zhonghui Biotech. Preclinical studies have shown that the vaccine can significantly increase antibody levels and neutralizing antibody titers, demonstrating a significant advantage in enhancing immune response.

At the same time, the IND application for another Class I new drug, the trivalent "Influenza Virus Subunit Vaccine (Adjuvanted)" jointly submitted by Zhonghui Biotech and Yihui Biotech, has also been accepted by the Center for Drug Evaluation of the China National Medical Products Administration. This marks the growing influenza virus vaccine portfolio of the company, with an increasingly comprehensive coverage of populations and options.

05‍

United Imaging Intelligence:Completion of the world's first case driven by a medical hybrid large model

Oral and Maxillofacial Reconstruction Surgery

Recently, Professor Su Yuxiong and Dr. Pu Jingya from the Department of Oral and Maxillofacial Surgery at the Faculty of Dentistry, The University of Hong Kong, completed the world's first oral and maxillofacial reconstructive surgery driven by a medical hybrid large model at Queen Mary Hospital in Hong Kong. In this procedure, the medical team used the United Imaging Intelligence multimodal surgical treatment platform uAI MERITS for the first time, innovatively addressing the clinical challenge of locating perforator vessels based on experience and intuition during traditional oral and maxillofacial reconstructive surgeries involving perforator flap preparation.

uAI MERITS, the United Imaging Intelligent Multimodal Surgical Treatment Platform, is a metaverse ecosystem designed for machine-assisted interventions, treatments, and surgeries. Leveraging healthcare hybrid large model technology, it creates digital twins of patients, medical staff, and operational environments in surgical scenarios, providing comprehensive intelligent support for preoperative preparation, intraoperative navigation, and postoperative follow-up.

In this surgical plan, precise segmentation is achieved by using a Transformer model trained on various medical images before the surgery. During the operation, a multi-modal large model is employed to perform 3D image and video registration, perspective projection, and dynamic visual tracking in real time, providing guidance during the procedure and significantly improving surgical efficiency and accuracy. This application is one of the AI solutions launched by United Imaging Intelligence under its "full-stack, full-spectrum" strategy. To date, United Imaging Intelligence has developed over 100 AI applications, more than 50 of which are focused on clinical workflows, covering areas such as neurology, cardiovascular, thoracic, oncology, and surgery.

Dr. Pu Jingya marks the perforating vessels of the calf based on the 3D reconstructed vascular projection.

06‍
Boan Biotech: China's First Dulaglutide Injection
(GLP-1 Weekly Formulation) Approved for Clinical Trials in the U.S.‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Boan Biotech (6955.HK) announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of clinical trials in the United States for its self-developed dulaglutide injection (BA5101). BA5101 is a biosimilar of Trulicity® (Chinese name: Du Yida®), intended for glycemic control in patients with type 2 diabetes. This product is the first China-produced dulaglutide injection to be authorized for clinical trials in the U.S. Previously, BA5101, as the first biosimilar of Trulicity® to be submitted for marketing approval in China, had its marketing application accepted by the Center for Drug Evaluation in May this year.

The development process of BA5101 strictly follows the relevant biosimilar research guidelines in the United States, the European Union, and China. It has completed a series of progressively advanced studies in China, including pharmaceuticals, non-clinical, human pharmacokinetics, clinical efficacy, safety, and immunogenicity, fully demonstrating its overall similarity to the reference originator drug; the two are highly similar in quality, efficacy, safety, and immunogenicity. Currently, BA5101 has entered the review stage for marketing authorization application in China. The clinical trial recently approved for initiation in the United States is a randomized, open-label, single-dose, parallel-controlled three-arm clinical study, aiming to compare the pharmacokinetics, safety, and immunogenicity of BA5101 with the reference originator drug in healthy subjects. Boan Biotech plans to advance the registration and clinical work of this product in the United States and Europe and intends to promote it to more countries and regions worldwide.

07‍
Huiyu Pharmaceutical: Ferric Carboxymaltose Injection
Submission of Marketing Authorization Applications to 13 EU Countries/Regions‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍‍

Recently, Sichuan Huiyu Pharmaceutical Co., Ltd. has officially submitted marketing authorization applications for Ferric Carboxymaltose Injection in multiple specifications to 13 countries and regions in the EU through the DCP procedure, including the reference member state Germany and 12 other relevant countries and regions (Austria, Denmark, Spain, Finland, France, Ireland, Italy, the Netherlands, Norway, Portugal, Sweden, and the UK (Northern Ireland)).

Currently, the original product has been registered and launched in multiple countries and regions worldwide, with global sales reaching $1.58 billion in 2023.Huiyu Pharmaceutical's Ferric Carboxymaltose Injection has been proven to be equivalent to the reference preparation through comparative studies of nearly 30 pharmaceutical indicators and human bioequivalence.。April 24, 2024Huiyu Pharmaceutical Carboxymaltose Iron InjectionAccepted by the National Medical Products Administration.Currently, four non-Chinese enterprises have been approved for the generic version of Iron Carboxymaltose Injection in the EU.Huiyu Pharmaceutical is the first Chinese enterprise to file for registration of this product within the EU, which will meet patients' rapid iron supplementation needs and is expected to benefit more patients.

About Gortec Investment

GaoTJ Investment was founded in Shenzhen in 2001. It was the first in the industry to propose the investment model of "thematic industry investment," focusing on healthcare industry investments. It is primarily led by strategic equity investments, covering all stages including mergers and acquisitions, PE, VC, and angel investments. With a professional investment team that is one of the few in China deeply focused on the healthcare track, it has built an investment ecosystem platform for the healthcare industry, aiming to become a globally influential healthcare investment institution.

With assets under management exceeding 20 billion yuan, 35 healthcare industry funds, and over 170 invested companies, more than 110 of which are in the healthcare sector. Gortica's investment business is rooted in China while facing globally, with operational centers established in Shenzhen, Shanghai, Beijing, Hong Kong, and other locations. It is committed to investing in outstanding healthcare companies worldwide, bridging global capital with Chinese momentum for healthcare enterprises, and assisting entrepreneurs in building great companies.