The National Healthcare Security Administration will comprehensively promote strict supervision of drug traceability codes

On January 2nd, the National Healthcare Security Administration issued a document clarifying the comprehensive promotion of "code based" strict supervision from January 1st, 2025. It will fully leverage the value of drug traceability code data, build various big data models, expand regulatory application scenarios, and carry out precise crackdowns on illegal and irregular use of medical insurance funds such as swapping and reselling medical insurance drugs, empty brushing and brushing medical insurance cards, and forging prescriptions, and increase the intensity of disposal. The drug traceability code is the only "electronic ID card" for drugs. In April 2024, the National Healthcare Security Administration launched a pilot project for the collection and application of drug traceability codes nationwide. In early November 2024, a public inquiry was conducted on 46 designated pharmaceutical institutions regarding the repeated reimbursement of a certain drug traceability code, taking the first step in using traceability codes to carry out medical insurance fund supervision.

21 Comment: Drug traceability codes are a key task currently being promoted by the National Medical Insurance Administration, which can effectively prevent counterfeit drugs and drugs from flowing back, and strengthen the supervision of medical insurance funds. Currently, the National Healthcare Security Administration is working hard to promote the full scene collection and application of drug traceability codes in hospitals and pharmacies through protocol management of designated medical institutions. It is expected that the full scene application of drug traceability codes will be achieved by the end of June 2025, and the public's medication safety will be effectively guaranteed.

Medical device approval

The National Medical Products Administration approves the launch of China's first stem cell therapy drug

On January 2nd, the National Medical Products Administration conditionally approved the launch of China's first stem cell therapy drug, Amimatosa Injection, through the priority review and approval process. It is used to treat acute graft-versus-host disease (aGVHD) with hormone therapy failure mainly affecting the digestive tract in patients over 14 years old. It is reported that graft-versus-host disease is one of the main complications after allogeneic hematopoietic stem cell transplantation, which may cause death in severe cases. This drug is marketed as a prescription drug and will be used in hospitals with a doctor's prescription to treat corresponding diseases, providing patients with new treatment options.

Twice yearly administration of HIV long-acting therapy in Saranca ® Approved in China

On January 2nd, the National Medical Products Administration officially approved Gilead Sciences' Saranca ® Lenacapavir (Lenacapavir Sodium Injection and Tablets) is used in combination with other antiretroviral drugs to treat adult patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection who cannot achieve virological suppression with current regimens.

Theresa ® Approved for the treatment of stage III unresectable non-small cell lung cancer with EGFR mutation in China

On January 2nd, AstraZeneca announced that the China National Medical Products Administration officially approved Terdesia on December 25th, 2024 ® (English product name: TAGRISSO ®， The generic name: Axitinib Mesylate Tablets, abbreviated as "Axitinib", is used for the treatment of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) adult patients who have not experienced disease progression during or after platinum based radiochemotherapy, and who have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation. The approval based on the priority review by the China National Medical Products Administration's Center for Drug Evaluation (CDE) is based on the LAURA Phase III clinical trial results announced at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which have been simultaneously published in the New England Journal of Medicine.

New Novartis subsidiary SYS6010 has been included in the list of breakthrough treatment varieties

On January 2nd, New Novartis announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has included the drug SYS6010 (anti human EGFR humanized monoclonal antibody JS-1 conjugate injection) in the breakthrough treatment list by the Drug Evaluation Center of the National Medical Products Administration. The proposed indication is monotherapy for EGFR mutation positive advanced non-small cell lung cancer (NSCLC) that has failed treatment with EGFR-TKI and platinum based chemotherapy.

capital market

Puqi Pharmaceutical has completed a Series B financing of over 300 million yuan

On January 2nd, Puqi Pharmaceutical announced the completion of over 300 million yuan in Series B financing. According to the press release, this round of financing funds will be used for the phase 3 clinical research and NDA declaration of the existing core product, Promexinib (PG-011, pumecitinib) gel, in the treatment of mild to moderate atopic dermatitis in adults and adolescents, to expand the application of PG-011 in other indications and to follow up the clinical promotion of other innovative pipelines. In addition, the company plans to prepare for IPO application on the Beijing Stock Exchange, and the work is progressing in an orderly manner.

Industry Events

Eli Lilly officially announces the launch of Tilpotide in China

On January 2nd, it was learned from Eli Lilly China that the glucose dependent insulinotropic polypeptide (GIP)/glucagon like peptide-1 (GLP-1) receptor agonist tilboptin (trade name: Mufengda) ®） It is officially listed in China and covers two indications, including type 2 diabetes and weight loss. Mufengda currently has 4 specifications available in China, including 2.5 mg: 0.5ml, 5 mg: 0.5ml, 7.5 mg: 0.5ml, and 10 mg: 0.5ml. Mufengda is the world's first and currently the only weekly GIP/GLP-1 receptor agonist approved for type 2 diabetes and long-term weight management. The weight reducing version of Tilpotide generated a revenue of $3.018 billion in the first three quarters of 2024, ranking first in the global GLP-1 race with Novo Nordisk GLP-1 drug semaglutide.

21 reviews: GLP-1 drugs are seen as the next internet celebrity product, and Musk has repeatedly promoted this type of drug. Now that the commercialization process of Tilpotide in China has officially begun, the battle between the "weight loss leader" Smeaglutide and the "rising star" Tilpotide will become even more intense. The two will compete in various aspects such as clinical trials, production capacity, indications, and channels.

Global innovative temperature sensitive embolic agent GPN00289 welcomes the first patient to enroll

On January 2nd, Yuanda Pharmaceutical (0512. HK) announced that its globally innovative temperature sensitive embolic agent product GPN00289, used for the treatment of vascular rich benign and malignant tumors, has completed its first patient enrollment in a registered clinical study for arterial chemoembolization of primary liver cancer in China. It is reported that GPN00289 has obtained the qualification certification for innovative medical devices from the National Medical Products Administration. This research and development progress is another significant development by Yuanda Pharmaceutical in the field of nuclear drug anti-tumor diagnosis and treatment in the direction of tumor intervention.

Hepalin obtains commercial license for gabapentin capsules in the United States

On January 2nd, Happyl announced that the company signed a distribution agreement with Yongtai Pharmaceutical on December 31st, 2024, granting Happyl a license to commercialize Gabapentin capsules throughout the United States. Heprui will purchase the subject drug from Yongtai Pharmaceutical at the agreed price and be responsible for the commercialization of the subject drug in the US market. Gabapentin is a commonly used antiepileptic drug, widely used to treat neuropathic pain and other painful disorders. This cooperation is a reflection and exploration of Heppure's commitment to international operations and its strategy to assist Chinese pharmaceutical companies in expanding their drug market to Europe and America. The company will be responsible for the commercialization of the target drug within the cooperation area and bear the related costs. There is uncertainty about whether the commercialization promotion can achieve the expected benefits.

Xinda Biotech authorizes an ADC drug to Roche

On January 2nd, Xinda Biotechnology (01801. HK) announced that it will grant Roche the exclusive global rights to a new drug IBI3009. According to the agreement, Sinovac Biotech grants Roche IBI3009 exclusive rights for global development, production, and commercialization. Both parties will jointly be responsible for the early development of the ADC (antibody conjugated drug) candidate drug, and subsequent clinical development will be handled by Roche. Xinda Biotech will receive a down payment of $80 million, potential milestone payments for development and commercialization up to $1 billion, and a gradient sales commission based on global annual net sales in the future. IBI3009 is a new generation ADC drug targeting DLL3, and this collaboration aims to provide a novel treatment option for patients with advanced small cell lung cancer (SCLC).

Public opinion warning

Online rumors suggest that medical personnel are suspected of involvement in baby buying and selling, and a joint investigation team has been established in Datong, Shanxi

On January 2nd, media reported that a joint investigation team was established in Datong City to investigate the alleged involvement of personnel from the First People's Hospital of Datong City in the sale of infants, as reported on the internet. Any illegal or disciplinary violations discovered will be dealt with seriously in accordance with the law and discipline.

The drug listing application of a subsidiary of Sinopharm Modern Holdings is not approved

On January 2nd, Sinopharm Modern announced that its subsidiary, Sinopharm Zhijun, received a "Notice of Non Approval of Drug Listing Application" issued by the National Medical Products Administration. Its application for the listing of phosphomycin tromethamine granules did not meet the relevant requirements for drug registration and was not approved. This drug is mainly used to treat urinary tract infections caused by sensitive bacteria. The cumulative R&D investment of Guoyao Zhijun is approximately 11.5408 million yuan, and the rejection of this approval will not have a significant impact on the company's current performance. Subsequently, a comprehensive evaluation will be conducted on the necessary elements for reapplying for listing, and research and registration work will be initiated in a timely manner.