Gilead's Trop-2 ADC Trodelvy Fails Phase 3 Trial in Previously Treated Metastatic NSCLC

Source: 21st Century Economic Report

● Hunan Issues Document to Carry Out Inter-Provincial Price Linkage for Drugs Listed on the 2024 Provincial Platform

On January 22, the Hunan Provincial Medical Security Bureau and the Hunan Provincial Public Resources Trading Center jointly issued the "Notice on Carrying Out Inter-Provincial Price Linkage for Drugs Listed in 2024." Against the backdrop of the National Medical Security Administration's price governance of 'four-same drugs,' this Notice outlines the work arrangements for inter-provincial price linkage of listed drugs. The linkage period is from January 22 to 31, 2024, 17:00, and no withdrawal applications from companies will be accepted during this price linkage. The Notice indicates that the scope of this price linkage includes drugs already listed in the province’s procurement subsystem (including drugs under record-filing procurement). The drugs are categorized into three types: national procurement, alliance procurement, and non-procurement drugs, each subject to different price linkage methods.

After the recent linkage of drug prices, the Hunan Provincial Medical Insurance Bureau, in collaboration with the Hunan Provincial Public Resources Trading Center, relied on the national pharmaceutical price and bidding procurement data platform to comprehensively review the online listing prices of drugs. Classified measures were adopted: non-selected drugs from national and joint procurement with evidently high listing prices were flagged for key monitoring through the bidding and procurement management system; drugs that did not truthfully report low out-of-province prices and implemented unfairly high or discriminatory prices in Hunan were, after consultation, included in the pharmaceutical bidding and procurement credit evaluation or had their online listing qualifications in Hunan canceled depending on the situation.

Relevant pharmaceutical manufacturing enterprises must attach great importance, carefully review the listing and transaction prices of their products across China, especially comparing the differences in the smallest formulation units among different specifications and packages of the same product. Enterprises are required to truthfully report price information within the specified timeframe to avoid being included in the "dishonesty" list due to false reporting, concealment, or failure to adjust prices as required.

● TRIASTEK's 3D Printed Gastric Retention Anticoagulant Approved for Clinical Trials

On January 19, TRIASTEK announced that the China National Medical Products Administration (NMPA) had approved the Investigational New Drug (IND) application for its 3D-printed gastric retention drug product, Apixaban Gastric Retention Extended-Release Capsules (T20G). The product is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Public information indicates that T20G is a modified novel oral anticoagulant (NOAC) product.

● Hansoh Pharma's Novel Drug for Treating Diabetes and Obesity Approved for Clinical Trials

China's National Medical Products Administration Center for Drug Evaluation (CDE) announced on its official website that the Phase 1 new drug HS-10501 tablets, submitted by Hansoh Pharma, have been approved for clinical trials. The drug is intended for the treatment of adult Type 2 diabetes and adult obesity. According to Hansoh Pharma’s announcement, this is a small molecule new drug independently developed by the company.

● Simnova's Dual CAR-T Therapy Receives FDA Orphan Drug Designation

On January 23, Simnova announced that it had received formal feedback from the U.S. FDA, granting orphan drug designation to its self-developed SNC109 injection for the treatment of malignant glioma. Public information shows that the SNC109 injection is a dual CAR-T cell therapy developed by Simnova based on its BiTE CAR-T platform, carrying two CAR molecules. Previously, the product had received clinical tacit approval from China's CDE.

●Simnova Applies for Bankruptcy Liquidation

Recently, the Yuhang District People's Court of Hangzhou City, Zhejiang Province, announced: Based on the application of Simnova, it has ruled to accept the case of the company's bankruptcy liquidation.

Public information shows that Simnova officially began operations in 2018. It is committed to biopharmaceutical R&D, with registered capital of 30 million yuan. Currently, its main focus is on the development of antibody-based drugs for cancer immunotherapy, gradually establishing an antibody discovery platform and a cancer immunotherapy drug R&D platform.

In December 2019, Simnova announced that the world's first tumor-targeted IL-15 fusion protein (BJ-001), which was independently developed by the company and has global patents, had successfully completed the first dosing of the first patient on December 4, 2019, at the Next Oncology clinical center in San Antonio, Texas, USA. In March 2023, Simnova also announced a clinical trial collaboration and drug supply agreement with Merck. The collaboration will study the safety and efficacy of BJ-001 (a tumor-targeted IL-15 fusion protein designed by Simnova) in combination with Merck's PD-1 inhibitor KEYTRUDA® (pembrolizumab) in an ongoing Phase I clinical trial.

●Wantai Bio预计2023年净利润下降74.66%-71.49%

On January 23, Wantai Bio announced that its estimated net profit for 2023 would be RMB 1.2 billion to RMB 1.35 billion, a year-on-year decrease of 74.66%-71.49%. The company stated that one of the core reasons is that its bivalent cervical cancer vaccine sales did not meet expectations due to the expanded age range of the nine-valent cervical cancer vaccine and market competition, resulting in a year-on-year decline of approximately RMB 4.2 billion.

● Recbio's Nine-Valent HPV Vaccine Expands to the Middle East and North Africa

On January 23, Recbio announced that the company had recently signed a framework agreement with Saudi Arabian pharmaceutical company SPIMACO regarding the recombinant nine-valent HPV vaccine REC603, and reached a licensing and strategic cooperation.

According to the agreement, Recbio has granted SPIMACO exclusive rights for the development, registration, and commercialization of the recombinant nine-valent HPV vaccine REC603 in 15 Middle Eastern and North African countries, including Saudi Arabia.

It is reported that this strategic cooperation covers a total population of approximately 380 million people in the Middle East and North Africa. Cervical cancer is the eighth most common tumor in Saudi Arabia and the eighth most prevalent chronic cancer among women aged 15-44. SPIMACO, one of the largest publicly listed pharmaceutical companies in Saudi Arabia, is deeply involved in government tenders and private pay markets across the Middle East and North Africa, with products widely distributed throughout the region.

ReCO Biotech's Recombinant Nine-valent HPV Vaccine REC603 is suitable for individuals aged 9 to 45, demonstrating good safety and immunogenicity in previous studies, and is currently in Phase III clinical trials in China. REC603 utilizes the Hansenula yeast expression system, enabling high-yield and stable expression of HPV virus-like particles, making the company’s candidate vaccine more suitable for commercial production. The company’s HPV vaccine industrial base has been constructed in accordance with the World Health Organization Prequalification (WHO PQ) requirements, with a maximum annual production capacity of 20 million doses of the recombinant nine-valent HPV vaccine.

●Sanofi Proposes $2.2 Billion Acquisition of Inhibrx's Core Asset INBRX-101

On January 23, Inhibrx and Sanofi announced that the two companies had entered into a definitive agreement under which Aventis, a subsidiary of Sanofi located in Pennsylvania, will acquire all assets and liabilities related to INBRX-101. INBRX-101 is a recombinant alpha-1 antitrypsin (“AAT”) augmentation therapy currently in registrational trials for the treatment of patients with alpha-1 antiprotease deficiency (“AATD”). Prior to the closing of the merger, all non-INBRX-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx’s non-INBRX-101 discovery pipeline, and its corporate infrastructure, will be spun off into a new publicly traded company, Inhibrix Biosciences (“new Inhibrx”).

According to the terms of the agreement, Sanofi will acquire all outstanding shares of Inhibrx through a merger. In return, each Inhibrx shareholder will receive: (i) $30.00 in cash per share, (ii) one contingent value right per share, representing the right to receive a $5.00 cash contingent payment upon achieving regulatory milestones, and for every four shares of Inhibrx common stock held, a share in New Inhibrx. Additionally, as part of the transaction, Sanofi will assume and repay Inhibrx's outstanding third-party debt, fund New Inhibrx with $200 million in cash, and retain an 8% equity stake. The boards of both Inhibrx and Sanofi have unanimously approved the transaction.

Taken together, the upfront cash portion, potential contingent value payments (if realized), and the assumption of Inhibrx's debt imply a total transaction value of approximately $2.2 billion. Additionally, Inhibrx’s shareholders will own 92% of the new Inhibrix, capitalized with $200 million in cash.

● Gilead's Trop2 ADC Drug Fails in Phase 3 NSCLC Clinical Trial

On January 22, Gilead Sciences announced that its Phase 3 EVOKE-01 study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).

Affected by this news, its stock price fell more than 10%. In a statement, Gilead stated that the survival period of patients receiving Trodelvy treatment showed no statistically significant difference compared to those receiving only chemotherapy, failing to meet the criteria for trial success. These data will be released at an upcoming medical conference.

Gilead stated that it plans to discuss the results with regulatory authorities and present the complete data at an upcoming medical conference.

Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC). It has demonstrated significant survival benefits in two different types of metastatic breast cancer and improved clinical outcomes for certain patients with second-line metastatic urothelial cancer. Trodelvy has not been approved by any regulatory authority for the treatment of metastatic NSCLC. The safety and efficacy for this indication have not been established.