Third Domestic Semaglutide Submitted for Marketing Approval; Fosun Kite to Be Renamed Fosun Carey; First Generic Dapagliflozin/Metformin Extended-Release Tablets Approved in China; NHC Issues Notice on Advancing Clinical Nutrition

1. Shanghai Implements the Listing of Injectable Agents by Minimum Formulation Unit

On September 19, the Shanghai Medical Centralized Bidding and Procurement Administration issued the "Work Notice on Standardizing the Listing of Injectable Agents," requiring all injectable agents (including aqueous injections, powder injections, infusions, and other types of injectables) already listed in Shanghai to uniformly reapply for listing based on the smallest formulation unit (such as vials, bottles, bags, etc.; combination packages are counted as sets), instead of being listed according to actual packaging (such as boxes).Drugs with a package quantity of "1" and a packaging unit of "vial/bottle/box" may temporarily not apply for code conversion.For the smallest preparation unit of triple-same injectables (same generic name, same brand, same content and volume), a unique medical insurance code is retained.Shanghai will no longer accept applications for the medical insurance codes of other forms of the smallest preparation units. All existing medical insurance codes of other forms will be discontinued from November 1st, and will be treated as invalid for medical institutions.At the same timeAll medical institutions are requested to prepare for the re-pricing of the smallest preparation unit of injectable drugs.WorkThe procurement and use of injections are calculated based on the price per minimum formulation unit multiplied by the actual number of units to form an order and settle payments. For special requirements regarding the actual packaging quantity of the injections to be procured, remarks can be made in the purchase order.

2. Notice of the General Office of the National Health Commission on Further Promoting Clinical Nutrition Work

Medical institutions should accelerate the implementation of the "National Nutrition Plan (2017-2030)"Requirements for the Bed-to-Personnel RatioMedical institutions that have established clinical nutrition departments should strengthen the management and construction of their clinical nutrition departments in accordance with the requirements of the "Guidelines for the Construction and Management of Clinical Nutrition Departments (Trial)" and provide necessary venues, equipment, and facilities to support the work of clinical nutrition department staff. Medical institutions with the necessary conditions are encouraged to attract talented individuals to engage in clinical nutrition work by improving salary and benefits. All medical institutions should reinforce holistic diagnostic and treatment concepts.Promote the establishment of a comprehensive diagnosis and treatment model covering "disease-nutrition-pain-psychology-rehabilitation" aspects, integrate relevant work into the diagnosis and treatment process in a coordinated manner, and systematically improve the medical standards.Medical institutions with the necessary conditions are encouraged to actively involve their clinical nutrition departments in multidisciplinary diagnosis and treatment teams for special, difficult, critically ill, and major surgery patients.Set up prenatal nutrition clinics, nutrition clinics for chronic disease patients, weight loss clinics, etc.,Clinical Nutrition Departments of medical institutions should organize and conduct nutritional screening and assessment in accordance with the "Regulations on Nutritional Screening and Assessment (Trial)", especially strengthening efforts for key populations such as the elderly, children, pregnant and postpartum women, cancer patients, and surgical patients, continuously improving the nutritional screening rate and standardized nutritional assessment rate for hospitalized patients.Strictly implement relevant diagnostic and treatment standards, clinical pathways, etc., and standardize the diagnosis and treatment of diseases such as nutritional disorders, nutritional metabolic disorders, and obesity.

3. The Center for Drug Evaluation of the National Medical Products Administration released the "Guiding Principles for Clinical Trials of Biosimilar Drugs of Denosumab Injection (Oncology Indications) (Trial)" and the "Technical Guiding Principles for Clinical Trials of Drugs for the Treatment of Chronic Heart Failure".

4. The Center for Medical Device Evaluation of the National Medical Products Administration is soliciting public opinions on the "Guiding Principles for the Registration Review of Intracranial Thrombectomy Stents (Draft for Comments)."

1. KANGSHENG Global Proposes to Acquire Benchmark Medical

On September 21, Kangsheng Global announced its intention to acquire 100% of the equity in Guangzhou Benchmark Medical. Established in 2015, Benchmark Medical is a pioneer in China in utilizing ctDNA methylation high-throughput sequencing technology for early cancer detection. Its early screening and diagnosis platform boasts the largest cancer epigenomics database in China, along with a world-class NGS data analysis center. Since its founding in 2015, Benchmark Medical has focused on two main areas—"a tube of blood" and "a tube of urine"—developing coverage for more than 70% of highly prevalent cancer types, including lung, breast, digestive system, and urinary system cancers, spanning the entire process from early cancer screening and diagnosis to recurrence monitoring and companion diagnostics. Regarding this acquisition of Benchmark Medical, Kangsheng Global stated in a press release that upon completion of the acquisition, Kangsheng Global will quickly enter the major solid tumor testing fields such as lung and stomach cancer through Benchmark Medical’s existing business segments, seizing the vast growth opportunities in the oncology specialty testing market and forming a new point of revenue growth.

2. Fosun Pharma wholly owns Fosun Kite, and Fosun Kite plans to rename itself as Fosun Kite Biotechnology Co., Ltd.

Fosun Pharma Announces Acquisition and Renaming of Fosun Kite to Strengthen Cell Therapy PlatformRecently, Fosun Pharma announced that its controlling subsidiary, Fosun Pharmaceutical Industry, plans to acquire a 50% stake in Fosun Kite held by Kite Pharma for US$27 million in cash. After the completion of this transfer, Fosun Pharma will hold 100% of Fosun Kite's shares and intends to inject US$10 million or an equivalent amount in RMB as a single shareholder to increase Fosun Kite’s capital. In addition, Fosun Kite, a wholly-owned subsidiary of Fosun Pharma, will be renamed Fosun Kite Biotechnology Co., Ltd. (Fosun Kite) and will serve as Fosun Pharma’s core platform for cell therapy technology. It will continue to focus on the field of tumor immunotherapy, promoting CAR-T cell therapy products to benefit more patients and meet unmet clinical needs. In the future, Fosun Pharma and Kite Pharma will maintain a long-term strategic partnership through a licensing cooperation model.

3. The Third Chinese-Produced Semaglutide Submitted for Market Approval

Recently, the marketing application for Semaglutide Injection submitted by Qilu Pharmaceutical has been accepted by the National Medical Products Administration. Based on previously disclosed research progress, it is speculated that the indication applied for this time is highly likely to be Type 2 diabetes. Thus, Qilu Pharmaceutical has become the third pharmaceutical company in China to submit an application for Semaglutide. In April 2024, Hangzhou Jiuyuan Gene Engineering Co., Ltd. submitted the marketing application for Semaglutide Injection (brand name: Jiutai), which was also accepted, with the indication for blood glucose control in adult patients with Type 2 diabetes, making it the first in China. Two months later, the marketing application for Semaglutide Injection from New Beijiang Pharmaceutical Company under Livzon Medicine was accepted by the Center for Drug Evaluation of the National Medical Products Administration, with the indication also for blood glucose control in Type 2 diabetes patients, making it the second in China.

1. The First Generic Version of Dapagliflozin Metformin Sustained-Release Tablets Approved in China

Recently, XuanTai Pharmaceutical's Dapagliflozin Metformin Sustained-Release Tablets have been approved for marketing in China, indicated for the treatment of type 2 diabetes. This is the first domestically produced generic version to be approved in China. The original formulation of Dapagliflozin Metformin Sustained-Release Tablets was developed by AstraZeneca, which received FDA approval in the United States in 2014 and was approved by the National Medical Products Administration (NMPA) in June 2023 for the treatment of type 2 diabetes.

2. Hanyu Pharmaceutical's Exenatide Injection Approved for Marketing in China

Recently, Hanmi Pharmaceutical's Exenatide Injection has been approved by the National Medical Products Administration (NMPA). The approved specifications are 5μg and 10μg, with packaging specifications of 1 vial/box and 3 vials/box. Exenatide is a glucagon-like peptide-1 (GLP-1) analog used to improve glycemic control in patients with type 2 diabetes. It is suitable for patients whose blood sugar remains poorly controlled when using metformin alone, sulfonylureas alone, or a combination of metformin and sulfonylureas. According to the NMPA, this is the second domestically produced exenatide injection to be approved for marketing in China after the product from Qinghai Chenfei Pharmaceutical. Exenatide belongs to the class of glucagon-like peptide-1 (GLP-1) analogs. Originally developed by Amylin Pharmaceuticals in collaboration with Eli Lilly, it was first approved by the FDA in April 2005 under the brand name Byetta, becoming the world’s first GLP-1 receptor agonist (GLP-1RA) to be marketed.

3. The Second Chinese-Manufactured Dydrogesterone Tablet Approved

Recently, Kelun Pharmaceuticals' Dydrogesterone Tablets have been approved for marketing by the National Medical Products Administration. Dydrogesterone Tablets, a steroidal drug developed by Solvay Sa, act as a PR agonist and can be used to treat diseases caused by insufficient endogenous progesterone, such as dysmenorrhea, endometriosis, secondary amenorrhea, irregular menstrual cycles, dysfunctional uterine bleeding, premenstrual syndrome, threatened or habitual abortion due to progesterone deficiency, infertility caused by luteal insufficiency, and luteal support in assisted reproductive technology. In June 2023, Aorui Pharmaceutical's Dydrogesterone Tablets were approved for marketing, becoming the first generic dydrogesterone drug approved for sale in China.

4. Ocumension Therapeutics' Zhiruitai Approved for Marketing in China, Can Be Used for Pediatric Allergic Conjunctivitis

On September 19, Ocumension announced that Zhiweitai (OT-1001, Cetirizine Hydrochloride Eye Drops) has been approved for marketing to treat ocular itching associated with allergic conjunctivitis in individuals aged 2 years and above. OT-1001 was developed by Nicox SA and represents the first time the U.S. Food and Drug Administration (FDA) has approved a novel formulation of the antihistamine Cetirizine Hydrochloride for topical ocular use. It is also the only FDA-approved ophthalmic antihistamine available for treating children aged 2 years and older. Since March 2019, Ocumension has held an exclusive license from Nicox SA to develop, manufacture, contract manufacture, import, export, use, distribute, market, promote, offer for sale, and sell OT-1001 in Greater China. In March 2020, these exclusive rights were extended to include 11 countries in Southeast Asia.

1. The 2024 Lasker Awards Announced: Chinese Scientist Zhijian Chen Receives the Basic Medical Research Award

On September 19, the Lasker Foundation announced the six winners of the 2024 Lasker Awards. This year, the Lasker Awards have established three categories: the Basic Medical Research Award, the Clinical Medical Research Award, and the Public Service Award. Founded in 1945, the Lasker Awards are annually presented to living individuals who have made significant contributions to medical science. As the most prestigious biomedical award in the United States, it is known as the "precursor to the Nobel Prize." Statistics show that 86 Lasker Award recipients have gone on to win the Nobel Prize. In the 2024 awards selection, Dr. Zhijian Chen from the University of Texas Southwestern Medical Center was honored with the Lasker Basic Medical Research Award for his contribution to the discovery of the cyclic GMP-AMP synthase (cGAS)-STING signaling pathway. Dr. Zhijian Chen is also a Chinese scholar to receive the Lasker Award following Tu Youyou, the 2015 Nobel Laureate in Physiology, and Professor Dennis Lo Yuk-ming, current President of the Hong Kong Academy of Sciences.

2. Novo Nordisk reaches $600 million collaboration to develop liver-targeted LNP delivery technology

On September 18, NanoVation Therapeutics announced a multi-year research and development partnership with Novo Nordisk aimed at advancing the development of innovative gene therapies for cardiometabolic diseases and rare diseases. This collaboration combines NanoVation Therapeutics' proprietary long-circulating lipid nanoparticle (lcLNP) RNA delivery technology with Novo Nordisk’s expertise in cardiometabolic and rare disease research, as well as clinical translation. Under the terms of the agreement, Novo Nordisk and NanoVation will collaborate on two main projects: developing base editing therapies for certain rare genetic disorders and pursuing up to five additional future targets for cardiometabolic and rare diseases. Novo Nordisk will secure a definitive global exclusive license to use NanoVation's LNP technology for the two main projects. As part of the multi-year agreement, NanoVation will receive research funding and is eligible for upfront payments and potential milestone payments totaling approximately $600 million, along with tiered royalties on future product sales.

3. "Baloxavir Marboxil" Successful Global Phase III Study for Influenza Post-Exposure Prophylaxis

On September 19, Roche announced positive results from the Phase III CENTERSTONE study of the antiviral drug Xofluza (baloxavir marboxil) for post-exposure prophylaxis of influenza virus. This is the first global Phase III study to demonstrate that an antiviral drug used to treat respiratory viral diseases has the benefit of reducing viral transmission. CENTERSTONE (MV40618) is a global, multicenter, randomized, double-blind, placebo-controlled clinical trial (n=4176) that evaluated the efficacy and safety of a single dose of Xofluza or placebo taken within 48 hours after symptom onset in influenza-infected individuals aged 5-64 to reduce further spread of the influenza virus among household contacts. The results showed that the study met its primary endpoint, indicating that Xofluza can effectively reduce further transmission of the influenza virus among household contacts.

1. Medtech Completes Nearly 200 Million Yuan in Series B Financing

Recently, Meditek Technology, a high-end ophthalmic device manufacturer in China, announced the successful completion of a nearly 200 million RMB Series B financing round. This round was jointly participated by Heda Zhejiang Province "4+1" Biopharmaceuticals and High-End Medical Device Fund, Mountain Blue Capital, and existing investor Decheng Capital. The funds will primarily be used to advance the registration applications and market promotion of the existing product pipeline. Meditek Technology focuses on providing full-cycle solutions for the ophthalmic medical field and has launched several core products, including the myopia refractive lens MPL, cataract intraocular lens IOL, and myopia correction defocus lenses.

2. XingSaiRuiZhen Completes Tens of Millions of Angel Financing, Incubated by Fosun Pharma's Fund

On September 18, XingSaiRuiZhen announced the completion of an angel round of financing worth tens of millions of yuan and officially launched its angel+ round financing plan. This round of financing was jointly invested by Fosun Pharma's Fosun Jian Capital New Drug Innovation Fund and Chuangrui Investment Jiaxing Chuangyan Fund. The funds will mainly be used for the continuous advancement of core pipelines and platforms, as well as the construction of the company’s team and R&D laboratories. XingSaiRuiZhen, established in July 2022, is a platform company incubated by Fosun Jian Capital New Drug Innovation Fund, focusing on cell therapy and regenerative medicine transformation. Fosun Jian Capital New Drug Innovation Fund, initiated by Fosun Pharma, is the first new drug innovation fund primarily adopting a holding incubation model. The fund was established in August 2020 with an initial scale of 1.5 billion yuan and completed its final closing in February 2021. The fund mainly invests in projects within the healthcare sector that are in their early or expansion stages, particularly those demonstrating technological innovation and rapid growth potential.

3. Huateng Bio Completes Tens of Millions in Series B Financing

Recently, Huateng Bio announced the successful completion of a multi-million yuan Series B financing round, which received strong support from Guangzhou Golden Control Fund and Tianhe Fund. The funds raised will mainly be used to advance the construction of a large animal model library and enhance preclinical CRO service capabilities. Located in Huangpu District, Guangzhou, Huateng Bio is a national high-tech enterprise specializing in biopharmaceutical research and development outsourcing services (CRO). The company’s core team is led by an academician and brings together top scientists from first-class universities, research institutions, and enterprises both in China and abroad. Centered on gene-edited large animal (miniature pigs, rabbits) models, the company covers scientific research services, innovative drugs, and the efficacy and safety evaluation of medical devices in preclinical stages. Currently, Huateng Bio has the production qualifications for multiple varieties of large experimental animals, owns a resource bank of 200+ animal models, and operates multi-platform R&D service centers, making it one of the larger one-stop preclinical R&D service providers in the Guangdong-Hong Kong-Macao Greater Bay Area.

1. Taimei Medical Passes HKEX Hearing, Set to Go Public

On September 16, 2024, the Hong Kong Stock Exchange (HKEX) website showed that Taimei Medical Technology had passed the HKEX listing hearing and would soon go public, with Morgan Stanley and CICC acting as joint sponsors. Taimei Medical Technology is a digital solutions provider specializing in China's pharmaceutical and medical device industries. Its clients mainly include pharmaceutical and medical device companies, contract research organizations (CROs), and other third-party service providers, as well as clinical research institutions. According to Frost & Sullivan, in terms of the number of clients, Taimei Medical Technology has become the most widely used digital solutions provider in China’s pharmaceutical and medical device research and development and marketing fields; based on 2023 revenue, Taimei Medical Technology is the largest digital solutions provider in China’s pharmaceutical and medical device research and development and marketing fields, with a market share of 5.9%.

2. AIVF Hospital Submits Application to HKEX Again

Recently, Aveyeaf Hospital Group has once again submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor. Aveyeaf Hospital is a provider of assisted reproductive technology (ART) and related services in China. Through four licensed hospitals in Guangdong Province, Tianjin City, and Yunnan Province, Aveyeaf Hospital focuses on providing ART and related services across many regions in China, attracting patients with infertility issues from 15 surrounding provinces, autonomous regions, and municipalities. According to Frost & Sullivan, in 2023, Aveyeaf Hospital ranked fourth among private ART service providers in China, conducting a total of 7,848 IVF cycles, accounting for approximately 1.0% of the total number of IVF cycles performed in China that year.

Shanghai Zhangjiang Biomedical Space Investment Attraction

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