1. Ministry of Finance: Plans to grant a 20% price evaluation preference for domestically produced products over non-domestically produced products in government procurement activities.

On December 5, the Ministry of Finance released the "Notice on Matters Related to the Standards and Implementation Policies for Domestically Produced Products in Government Procurement (Draft for Solicitation of Comments)", proposing,In government procurement activities, domestically produced products are given a 20% price evaluation preference over non-domestically produced products.

The specific reference to domestic product standards is:First, the product is manufactured within China, meaning that the transformation from raw materials and components to the final product occurs within China's customs territory, excluding OEM labeling or simple packaging. Second, the cost of components produced within China must meet a specified proportion requirement, with the exact ratio determined by product type and subject to dynamic adjustment. Third, for certain products, in addition to meeting the aforementioned conditions, it is also required that key components be manufactured within China and critical processes be completed within China.

Government procurement of domestically produced products standards currently apply to goods, mainly industrial manufactures., specifically referring to the products in the "Classification Catalogue of Government Procurement Items" under the goods category, but excluding agricultural, forestry, animal husbandry, sideline, fishery products and mineral products, etc., such as land, buildings and structures, cultural relics and exhibits, books and archives, special animals and plants, agricultural, forestry, animal husbandry and fishery products, minerals and minerals, electricity, city gas, steam and hot water, water, food, beverages and tobacco raw materials, intangible assets, etc.

In government procurement activities, domestically produced products are given a 20% price evaluation preference over non-domestically produced products.A 20% price deduction is applied to the quotations for domestically produced products., participate in the review with the deducted price. For procurement projects or procurement packages that include multiple products,The sum of the costs of products provided by the supplier that meet the domestic product standards accounts for more than 80% of the total cost of the products provided by the supplier., A 20% price deduction will be applied to the products provided by this supplier, and the deducted price will be used for evaluation.

The standard system will be established in stages. After the issuance of the Notice, the Ministry of Finance will collaborate with relevant departments to formulate requirements regarding the proportion of domestically produced components for certain products and key component and critical process requirements for specific products within 3 to 5 years, based on fully consulting opinions from all parties, including both domestic and foreign enterprises as well as industry associations.Previously, as long as the product was manufactured within China, it was considered a domestic product in government procurement activities.

2、NMPA Releases the 85th Batch of Reference Preparations for Generic Drugs; CDE of NMPA Seeks Public Comments on ICH 'M15: General Principles for Model-Informed Drug Development'.

1. Over $1 billion: DualityBio’s innovative preclinical ADC drug licensed to GSK

On December 4, Yingen Bio announced that it had entered into an exclusive licensing agreement with GSK for an antibody-drug conjugate (ADC) DB-1324. Under the agreement, GSK will obtain exclusive rights globally (excluding mainland China, Hong Kong, and Macao) to advance the research and development and commercialization of the ADC drug. According to the terms of the agreement, GSK will make an upfront payment of $30 million along with other pre-option milestone payments to secure exclusive rights to develop and commercialize DB-1324 globally (excluding mainland China, Hong Kong, and Macao). If GSK exercises the license option, Yingen Bio will receive an option exercise fee and subsequent milestone payments across different stages of development, regulatory registration, and commercialization, potentially amounting to up to $975 million. DB-1324 is an innovative ADC molecule developed based on Yingen Bio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugates (DITAC) platform. Currently in the preclinical development stage, its research direction may target gastrointestinal (GI) cancers. Additionally, this ADC drug has the potential to be used in combination with multiple oncology products from GSK, strategically complementing GSK’s oncology portfolio.

2. AstraZeneca Appoints New Head of China Business

Recently, AstraZeneca, the multinational pharmaceutical company currently under public scrutiny, announced its latest executive appointments. Iskra Reic, the current Global Executive Vice President of Vaccines and Immune Therapies, has been appointed as AstraZeneca’s Global Executive Vice President and Head of International Business, taking full responsibility for the overall strategy across regions including China, Asia and Eurasia, the Middle East and Africa, Latin America, Australia, and New Zealand. AstraZeneca explicitly stated that Iskra will succeed Leon Wang, who remains temporarily away from his position due to an ongoing investigation in China. Meanwhile, Lin Xiao, General Manager of AstraZeneca's biopharmaceutical business in China, will replace Mike Lai as the General Manager of AstraZeneca China, and Guan Dongmei will assume the role of General Manager for AstraZeneca China’s Oncology Business.

1. Simcere Pharmaceutical Announces Approval and Launch of New Stroke Drug, Xianbi Xin Sublingual Tablets

On December 2, Simcere Pharmaceutical announced that its Xianbixin Sublingual Tablets (generic name: Edaravone and Dextrorphan Sublingual Tablets) had been approved for marketing by the National Medical Products Administration (Approval No.: H20240041). It is used to improve neurological symptoms, activities of daily living, and functional disabilities caused by acute ischemic stroke. Xianbixin Sublingual Tablets were co-developed by Simcere Pharmaceutical and Ningdan New Drug and represent a significant research achievement from the National Key Laboratory of Neurology and Oncology Drug Development in China. The drug is a dual-target brain cell protector containing two active ingredients, edaravone and dextrorphan, which synergistically enhance antioxidant and anti-inflammatory effects. Clinical studies have shown that Xianbixin Sublingual Tablets can significantly reduce brain cell damage caused by acute ischemic stroke.

2. New Parkinson's Disease Treatment Drug Safinamide Approved in China

Recently, the marketing application for Safinamide Tablets, a new Category 5.1 drug submitted by Zambon, has been approved for the treatment of Parkinson's disease.Safinamide has a unique mode of action, including selective and reversible monoamine oxidase B (MAO-B) inhibition and blockade of voltage-dependent sodium channels, thereby modulating abnormal glutamate release. Additionally, MAO-B degrades dopamine, which is crucial for signal transmission in brain regions and important for smooth voluntary movement. Therefore, safinamide is expected to prevent the degradation of dopamine by MAO-B, thus alleviating motor function decline during the "off" periods in Parkinson's disease patients.

3. MSD Antibiotic Combination Approved for Marketing in China

Recently, Merck's antibiotic combination injection Imipenem/Cilastatin/Relebactam (Imipenem 500mg + Cilastatin 500mg + Relebactam 250mg) has been approved for marketing in China. Based on clinical trial progress, it is speculated that the indications approved this time are ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP). The active ingredients of Imipenem/Cilastatin/Relebactam include three antibiotics with different mechanisms, where Imipenem is a carbapenem antibiotic, Relebactam is a β-lactamase inhibitor, and Cilastatin is a dehydropeptidase inhibitor. In July 2019, Imipenem/Cilastatin/Relebactam was first approved for marketing in the United States under the trade name Recarbrio, applicable for treating complicated urinary tract infections (cUTI) and complicated intra-abdominal bacterial infections (cIAI) in adult patients with limited or no alternative treatment options. In June 2020, the indications for Imipenem/Cilastatin/Relebactam were expanded to include VABP and HABP.

4. Rare Disease New Drug Approved for Marketing in China

Recently, Ipsen's Odevixibat has been approved by the National Medical Products Administration (NMPA) for marketing in China, indicated for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged 6 months or older. PFIC is a rare genetic disorder where, despite the large bile ducts remaining open (cholestasis), children with this condition are unable to excrete bile from the liver, and the accumulation of bile acids in hepatocytes leads to liver disease and symptoms. The disease has been included in China’s first list of rare diseases. Odevixibat is a highly selective, non-systemic ileal bile acid transporter inhibitor that alleviates cholestasis and improves pruritus and sleep.

5. Hengrui Medicine's Two Innovative Drug Combination Therapy Approved for New Indications

Recently, Hengrui Medicine's two innovative drugs, Fluazoparib and Apatinib, have received approval from the National Medical Products Administration (NMPA) for new indications. This marketing application was previously granted priority review by the Center for Drug Evaluation (CDE) of NMPA. The approved indication is: Fluazoparib capsules as monotherapy or in combination with Methyl Apatinib for the treatment of HER2-negative breast cancer patients with germline BRCA mutations (gBRCAm). Fluazoparib, an orally administered PARP inhibitor developed by Hengrui Medicine, was approved for marketing in December 2020 and has been approved for three indications in the treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Apatinib, a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR) developed by Hengrui Medicine, was approved for marketing in October 2014 and has been approved for three indications in the treatment of gastric cancer and liver cancer.

6. Luye Pharma's New Drug for Small Cell Lung Cancer Approved for Marketing in China

Recently, the marketing application for Lurbinectedin Injection, a new drug classified under Category 5.1 co-filed by PharmaMar and Luye Pharma, has been approved by the National Medical Products Administration (NMPA). The indication approved this time is: for the treatment of adult patients with metastatic small cell lung cancer (SCLC) whose tumors have progressed during or after platinum-based chemotherapy. Lurbinectedin is a selective oncogene transcription inhibitor, initially developed by PharmaMar, and Luye Pharma has obtained exclusive rights to develop and commercialize the drug in China.

7. Fosun Pharma's Hongqi Pharmaceutical Drug-Resistant Tuberculosis Medication Pureni Approved for Marketing

Recently, Prontomanid Tablets developed by Shenyang Hongqi Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Fosun Pharma, have been approved for marketing by the National Medical Products Administration (NMPA). Prontomanid is a new molecular entity drug developed by the Global Alliance for TB Drug Development. It was approved by the U.S. FDA in 2019 for use in combination with Bedaquiline and Linezolid to treat specific patients with highly drug-resistant tuberculosis. With the approval of Prontomanid, China's drug-resistant tuberculosis treatment is about to enter a new era of six-month short-course therapy. Prontomanid is an entirely new nitroimidazole compound used against mycobacteria, with a unique multi-action mechanism that exhibits both bactericidal and sterilizing activity. In aerobic conditions, it kills replicating Mycobacterium tuberculosis by inhibiting mycolic acid biosynthesis and impeding cell wall synthesis. In anaerobic environments, it releases nitric oxide, exerting respiratory toxicity on non-replicating bacteria, thereby achieving bactericidal effects. Its specific mechanism involves targeting the pentose phosphate pathway, causing an accumulation of phosphorylated pentoses, leading to toxic levels of methylglyoxal, which halts cell growth.

1. Over 3.3 Billion Yuan: Gilead Purchases Another ADC Project

On December 3, Gilead and Tubulis announced that they had entered into an exclusive option and license agreement to discover and develop an ADC drug targeting solid tumor antigens. Under the agreement, Gilead will gain access to Tubulis' proprietary technology platforms, Tubutecan and Alco5. The two companies will collaborate to select the optimal technical solution, with Tubulis leading the discovery and development of the candidate drug. The goal is to design an ADC candidate drug based on a topoisomerase I inhibitor, which will feature superior biophysical properties and stability to address current therapeutic challenges such as insufficient durability and off-target toxicity. According to the terms of the agreement, Tubulis will receive a $20 million upfront payment and, if Gilead exercises its option, an additional $30 million option exercise fee. Furthermore, Tubulis is eligible to receive up to $415 million in development and commercialization milestone payments, as well as tiered royalties ranging from mid-single-digit to low-double-digit percentages on sales of the collaboration products once marketed. The potential total value of this collaboration deal is up to $465 million (approximately RMB 3.38 billion).

2. Weight Loss Over 45 Pounds: Eli Lilly Announces Positive Data from Latest Phase 3b Trial of Key Therapy

On December 4, Eli Lilly announced the topline results of the SURMOUNT-5 Phase 3b open-label randomized clinical trial. The results showed that, compared with the weight-loss version of semaglutide, Wegovy, the weight-loss version of tirzepatide, Zepbound, achieved a 47% relative weight loss effect. On average, tirzepatide led to a 20.2% weight loss in participants, while the semaglutide group saw a 13.7% reduction. Patients in the tirzepatide treatment group lost 55.6 catties, while those in the semaglutide treatment group lost 30 catties, meaning Zepbound resulted in over 15 catties more weight loss than Wegovy.

1. Yafei Biotech Announces Completion of Over 400 Million Yuan in Series B2 Financing

This round of financing was led by SDIC Venture Capital, with participation from well-known investment institutions such as Huachuang Capital, Hongcheng Investment, Guozheng Investment, Guosheng Capital, Hongfu Assets, Anxin Guosheng Micro-Core Fund, Guoyuan Innovation Investment, and Hongyao Sci-Tech Innovation. Yafei Biologics, established in May 2012, is a clinical-stage biopharmaceutical company focused on the development of innovative anti-cancer drugs. It owns a 100% self-developed product pipeline, with each drug having global patents, and has built intelligent drug platforms for small-molecule and large-molecule tumor microenvironment-specific activation. The small-molecule platform mainly enhances efficacy and reduces toxicity through innovative treatment methods that involve targeted delivery in the tumor microenvironment, localized activation, and release of active substances. The large-molecule platform transforms current immune checkpoint inhibitors and immune-related cytokines into second-generation tumor microenvironment-activated new drugs. The first conjugated small-molecule drug produced by Yafei Biologics has entered the Pivotal registration clinical stage.

2. Cadwell Completes Nearly 200 Million Yuan in Series B Financing

Led by Abies Creek Capital with an investment of 50 million yuan, other institutions such as Wuhan GaoKe, Hongtai Industrial Finance, Hubei Science Investment, and Jiuzhou Tong ChuChang Investment followed suit. The funds from this round will be used for the clinical development and market expansion of the company's products in the field of gynecological tumor diagnosis and treatment. Kaidewei was founded by Professor Ma Ding, an academician of the Chinese Academy of Engineering and a professor at Tongji Hospital of Huazhong University of Science and Technology. It has deeply laid out the entire process of screening, diagnosis, prevention, and treatment of gynecological tumors. Two of its original in-vitro diagnostic kits have been approved to enter the National Medical Products Administration’s innovative medical device review fast track for two consecutive years. Meanwhile, Kaidewei has also developed cutting-edge international innovative therapies such as oncolytic viruses and HPV therapeutic vaccines. Currently, its new recombinant oncolytic adenovirus product has been approved to enter Phase I clinical trials.

3. Qiheshengke Completes Over 200 Million Yuan in Series A Financing

This round of financing was led by Beijing Medical and Health Industry Investment Fund, with Chang Development Group and Mingzhe Assets participating as follow-up investors, and existing shareholder Chen De Capital continuing to support. Qihe Biotech is a biotechnology company that focuses on developing new gene-editing technologies to create superior biological traits and products. It has already established an independent and self-controlled gene-editing technology system, achieving significant progress in multiple areas such as the discovery and optimization of new gene-editing tools, the development of safe and efficient delivery systems, and the creation of breakthrough germplasm resources.

1. Yinnuo Medicine Submits Listing Application to HKEX Main Board; Core Product Poised to Enter Commercialization Phase

Yinuo Pharmaceuticals was established in 2014 and has been committed to researching and developing innovative therapies for the treatment of diabetes and other metabolic diseases. It is the first company in Asia and the third globally to advance an original, human-derived, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist into the registration approval stage. Its core product, Yisupagrupeptide α (brand name: Yinoqing), is about to enter the commercialization phase. This product is a human-derived, long-acting GLP-1 receptor agonist used to treat T2D and other metabolic diseases. Clinical studies of Yisupagrupeptide α have demonstrated its rapid onset, strong and sustained efficacy, longer half-life, and good safety profile. Financially, Yinuo Pharmaceuticals' R&D expenditures were approximately RMB 267 million, RMB 492 million, and RMB 51.905 million for the years 2022 to the first half of 2024, respectively. During the same periods, the company's annual losses were approximately RMB 301 million, RMB 733 million, and RMB 75.275 million, respectively.

2. Bokang Vision Cloud Submits IPO Application to HKEX for the Third Time

Recently, BioKang Vision Cloud submitted an application for listing on the Hong Kong Stock Exchange, with UBS Group, CCB International, and Huatai International acting as joint sponsors. This marks the third submission by BioKang Vision Cloud to the Hong Kong Stock Exchange in half a year. BioKang Vision Cloud is a clinical-stage ophthalmic biotechnology company dedicated to developing various therapies. Its pipeline includes two core products (CBT-001 and CBT-009), both of which were self-developed. Among them, the core product CBT-001 is applicable for treating pterygium (a benign proliferative ocular surface disease). Phase 3 multi-regional clinical trials for CBT-001 were initiated in June 2022 in the United States and in September 2023 in China. Currently, CBT-001 is the world’s first drug for this indication to enter Phase 3 clinical trials, and globally, there are no approved drug therapies available yet. The core product CBT-009 is used to treat juvenile myopia (myopia in children and adolescents aged 5 to 19 years). It completed Phase 1/2 clinical trials in January 2023 and submitted an Investigational New Drug application to the U.S. Food and Drug Administration in July 2024.

Text | MedValley

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