Lilly's Alzheimer's Therapy Wins Unanimous PCNS Support; Phase III NSCLC Patients May See Further Survival Extension

Jun 12, 2024 21:00 CST Updated 21:00

VISHEE

Developer, Manufacturer, and Distributor of Rehabilitation Medical Devices

Source: 21st Century Economic Report

Editor | Zhang Weixian, Xu Qiulian

Welcome to follow the latest events in the pharmaceuticals and health industry with the 21st Century Economic Report's New Health team!

Policy Trends

NMPA Issues "Intelligent Monitoring of Blood Product ProductionThree-Year Action Plan (2024-2026)

On June 11, the General Office of the National Medical Products Administration issued the "Three-Year Action Plan for Smart Regulation of Blood Products Production (2024-2026)." It proposed to urge blood product manufacturers to strictly implement the requirements of laws and regulations such as the "Pharmaceutical Administration Law," the "Regulations on the Administration of Blood Products," the "Measures for the Supervision and Administration of Pharmaceutical Production," and the annex of "Good Manufacturing Practice for Pharmaceutical Products (2010 Revision)" on blood products. Efforts should be made to accelerate the informatization construction in the production and testing processes of blood products and promote the establishment of an informatized management system covering the entire process from the entry of raw plasma into the factory to production and testing. Following the principle of first implementation and phased promotion, by the end of 2026, through a three-year action plan, the informatized management of blood product manufacturing enterprises will be basically achieved, effectively improving the efficiency of blood product regulation and strongly ensuring the quality and safety of blood products.

21 Comments: The "14th Five-Year Plan" for Cybersecurity and Informatization in Drug Regulation requires the promotion of digital and intelligent transformation and upgrading of the pharmaceutical industry. In 2024, the National Medical Products Administration's drug supervision tasks are clear, with a focus on promoting blood product manufacturing enterprises to establish a digital management system covering the entire process of raw plasma warehousing, production, and testing.

Drug and Device Approval

Extracorporeal Shock Wave Therapy System Obtains Medical Device Registration Certificate

VISHEE Medical announced on the evening of June 11 that the company had recently received one "Medical Device Registration Certificate" issued by the Jiangsu Provincial Drug Administration. The product name is Extracorporeal Shock Wave Treatment System. It is suitable for the adjuvant treatment of periarthritis, calcific tendinitis of the shoulder, lateral epicondylitis of the humerus, subacromial pain syndrome, trochanteric pain syndrome of the femur, patellar tip syndrome, osteochondritis of the tibial tuberosity, medial tibial stress syndrome, Achilles tendonitis, plantar fasciitis, myofasciitis, and nonspecific low back pain.

Bayer's New Targeted Lung Cancer Treatment Receives Breakthrough Therapy Designation

Bayer announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has recently granted Breakthrough Therapy Designation to Bayer's novel targeted lung cancer treatment, BAY 2927088. The indication is for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations who have previously received one systemic therapy.

BAY 2927088 is a tyrosine kinase inhibitor under research by Bayer. It is being developed as a potential novel targeted therapy for the treatment of non-small cell lung cancer (NSCLC) patients with HER2 activating mutations. In February this year, BAY 2927088 received Breakthrough Therapy Designation from the U.S. FDA.

Latex Catheter Receives FDA Approval in the United States

Virtue Medical announced on the evening of June 11 that its wholly-owned subsidiary, Hainan Virtue Medical Technology Development Co., Ltd., had recently received notification from the U.S. Food and Drug Administration (FDA) that Hainan Virtue's product, Wellead® Latex Foley Catheter (Virtue Latex Urinary Catheter), had been approved for registration by the U.S. FDA.

COVID-19 and Influenza A/B Antigen Rapid Combined Test Kit Receives U.S. FDA Emergency Use Authorization

Oriental Biotechnology announced on the evening of June 11 that its wholly-owned subsidiary, US Hengjian Biotechnology Co., Ltd., has recently obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its rapid combined antigen test for COVID-19, Influenza A, and Influenza B (nasal swab).

Astellas' Novel Protein Degrader Approved for Clinical Trials in China

On June 11, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration announced that the investigational new drug ASP3082 Injection, submitted by Astellas, had been approved for clinical trials. It is intended to be developed for previously treated locally advanced (unresectable) or metastatic malignant solid tumors carrying the KRAS G12D mutation. Public data indicates that this is a novel KRAS G12D protein degrader with high selectivity and efficiency, currently undergoing Phase 1 clinical studies internationally.

Capital Market

Langxin Bio Completes B+ Round Financing

On June 11, gene therapy innovator Laxin Biotechnology announced the completion of its B+ round of financing, led by the Shanghai Biomedical Industry Fund with participation from other shareholders such as Lianhe Investment. This round of financing will further accelerate Laxin Biotechnology's research, development, and industrialization process in the field of innovative gene therapy drugs.

Xin Guang Bio Completes Tens of Millions of Yuan in Pre-A Round Financing

It is reported that Shanghai Xinguang Biomedical Co., Ltd. has announced the completion of a multi-million Pre-A round of financing co-invested by Haimaide Venture Capital, Shanghai Tianxiang Industry, and existing shareholders. Xinguang Biomedical was founded in 2018 in the Fudan Science Park and is committed to promoting the convenience of dialysis technology, allowing more than three million uremic patients worldwide to return to a normal life.

Amber Therapeutics Completes $100 Million Series A Financing

On June 11, Amber Therapeutics announced the successful completion of a $100 million (£80 million) Series A financing round. According to the press release, this financing represents one of the largest Series A rounds ever for a European medtech company, led by New Enterprise Associates (NEA), with new investors F-Prime Capital, Lightstone Ventures, and Intuitive Ventures, as well as existing investors Oxford Science Enterprises (OSE) and 8VC participating in the investment.

Amber Therapeutics is developing Amber-UI, a groundbreaking adaptive neuromodulation therapy for treating women with mixed urinary incontinence (MUI), aiming to transform clinical outcomes and quality of life for a large number of treatment-naïve patients.

Jinghua Pharmaceutical Plans to Invest 1 Billion YuanVISHEE Builds Modern Production Base in Jiangsu

On June 11, Jinghua Pharmaceutical announced that it had recently signed the "Cooperation Framework Agreement for the Modernized Production Base Construction Project of Jinghua Pharmaceutical" with the Management Committee of Nantong North High-tech Industrial Development Zone in Jiangsu Province, planning to construct a modernized production base for traditional Chinese medicine and chemical drug preparations.

Jianzhijia Plans to Invest Up to 10 Million Yuan to Establish a Wholly-Owned Subsidiary

Jianzhijia Announces Plan to Establish a Wholly-Owned Subsidiary for Medical ServicesOn the evening of June 11, Jianzhijia announced that the company plans to invest up to 10 million yuan of its own funds to establish a wholly-owned subsidiary, Yunnan Jianzhijia Medical Services Co., Ltd. (subject to final registration). The establishment of this subsidiary aims to unify the investment and management of grassroots medical service institutions that need to be set up in various provinces in the form of a company or non-profit organization. This move is intended to address and overcome regulatory policy obstacles that exist in setting up grassroots medical institutions in certain provinces, ensuring the steady progress of the "clinic + pharmacy" collaborative model. By obtaining outpatient pooling qualifications through grassroots medical institutions, the company seeks to attract customer traffic and achieve business growth, offsetting the negative impact of reduced personal medical insurance account funding. Collaborating with pharmacies, it will break through the limitations of single-format clinics, bringing chronic disease customer flow to pharmacies and expanding specialized, chronic disease, and health product omnichannel business growth.

Industry Highlights

Lilly's Donanemab Receives Unanimous Support from PCNS

On June 10 local time, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the U.S. Food and Drug Administration (FDA) announced the results of the meeting on the Biologics License Application (BLA) for Donanemab for the treatment of early symptomatic Alzheimer's disease. The committee unanimously voted 11:0 in favor of the drug's efficacy and agreed that its benefits outweigh the risks.

21 Comments: The positive voting result of the PCNS this time undoubtedly injects a strong boost for the approval and market launch of Donanemab. This drug is expected to become the second of its kind to reach the market, following Eisai/Biogen's similar antibody Leqembi. Meanwhile, reporters from the 21st Century Economic Herald also found that the official website of the Center for Drug Evaluation under the National Medical Products Administration announced in November 2023 that Donanemab Injection had been included in the list of priority review products.

Professor Lu Shun from Shanghai Chest Hospital: Patients with Stage III Non-Small Cell Lung Cancer May Further Extend Survival

Non-Small Cell Lung Cancer (NSCLC) is the most common subtype, accounting for approximately 80%-85% of all lung cancers. Based on factors such as tumor size, extent of invasion, lymph node metastasis, and distant metastasis, non-small cell lung cancer can be divided into stages I, II, III, and IV.

"Since about 30%-40% of patients in China are initially diagnosed at stage III, the treatment of stage III lung cancer has become a clinical focus," said Professor Lu Shun, Director of the Oncology Department at Shanghai Chest Hospital affiliated with Shanghai Jiao Tong University and Director of the Shanghai Pulmonary Tumor Clinical Medical Center.

Since at stage III, cancer cells have not yet spread beyond the lung area to distant organs, radical treatment options can still be administered for stage III lung cancer. Currently, the treatment for stage III lung cancer is divided into three main categories: resectable, potentially resectable, and unresectable, with complex and diverse treatment methods. Among these, the majority are patients with unresectable stage III non-small cell lung cancer, whose disease progression is the most severe.

"Unfortunately, although a large number of studies have established concurrent chemoradiotherapy as the standard treatment for stage III unresectable NSCLC, this approach has not been able to further improve patient survival rates. For example, induction chemotherapy before CRT does not prolong survival, increasing the radiation dose significantly shortens patient survival, different chemotherapy drugs show no significant difference in survival benefits, and consolidation chemotherapy does not significantly extend median OS or PFS," commented Professor Lu Shun. "Although the treatment strategy of 'chemoradiotherapy plus immunotherapy consolidation' can significantly improve progression-free survival (PFS) in patients with stage III unresectable NSCLC, the overall 5-year survival rate remains below 20%. Additionally, in the United States and Europe, about 10% to 15% of non-small cell lung cancer (NSCLC) patients have EGFR mutations, while in Asia, the figure is 30% to 40%. The regimen of 'concurrent chemoradiotherapy plus immunotherapy consolidation' shows even less efficacy in patients with driver gene EGFR mutations, who are also more prone to brain metastases. Existing treatments cannot effectively control brain metastases. There remains a significant unmet treatment need for patients with EGFR-mutated, stage III unresectable NSCLC."

Professor Lu Shun said that with the successive launches of first, second, and third-generation EGFR-TKIs, targeted therapy for EGFR-mutated non-small cell lung cancer has remained a key focus of research in China, bringing new breakthroughs and advancements in the treatment of Stage III inoperable NSCLC with EGFR mutations.

First-in-Class Small Molecule for Liver Disease Receives FDA Approval

Ipsen announced today that the U.S. FDA has granted accelerated approval to Iqirvo (elafibranor) 80 mg tablets for use in combination with ursodeoxycholic acid (UDCA) to treat adults with primary biliary cholangitis (PBC) who have an inadequate response to UDCA, or as a monotherapy for patients who are intolerant to UDCA.

According to the press release, Iqirvo is the first new drug approved for the treatment of the rare liver disease primary biliary cholangitis in nearly a decade. Ipsen has submitted regulatory applications to the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), with final regulatory decisions expected from both in the second half of 2024.

Public Opinion Early Warning

ChemDiagnostic Discloses Litigation Progress Announcement

On the evening of June 11, Chemclin Diagnostics released an announcement regarding the progress of related litigation, showing that the case is in the first-instance judgment phase. An appeal against the first-instance judgment has been received from the defendant, and the second instance has not yet commenced. The listed company’s position in the case is as the appellee and the plaintiff in the first instance. The amount involved totals 35,000,000 yuan and all litigation costs of this case.

Regarding whether this lawsuit will have a negative impact on the profits and losses of the listed company, Chemclin Diagnostics stated that in this legal case, Chemclin Diagnostics Technology Co., Ltd. has filed for compensation regarding the trademark infringement dispute as a legitimate measure to safeguard its own legal rights and interests, which will not affect the company’s normal production and operation. Since the appeal has not yet been heard in court, the final judgment is still uncertain, and the ultimate actual impact will depend on the subsequent progress of the litigation. The company will continue to monitor the developments of the aforementioned matters and fulfill its information disclosure obligations in a timely manner in accordance with relevant regulations.

Part of the shares of the actual controller of SIHUAN BIOLOGICAL have been judicially re-frozen

On the evening of June 11, Sihuan Biotech announced that according to the "Administrative Penalty Decision" ([2020] No. 17) delivered by the China Securities Regulatory Commission to Jiangsu Sihuan Biotech Co., Ltd., Lu Keping has control over the accounts of Lu Yu, Yu Qinfen, Sun Xian, Yu Xufa, Zhou Jun, Zhang Huifeng, Xu Ruikang, Zhao Long, Xu Zhi, Chen Jianguo, Wang Hongming, Sun Yifan, and Jiangsu Deyuan Textile Apparel Co., Ltd. Moreover, he has a concerted action relationship with Zhao Hong, Hua Ying, Ni Lifeng, and He Bin, forming a group of persons acting in concert. He became the actual controller of the company no later than May 23, 2014.

Today, the company learned through the system of China Securities Depository and Clearing Co., Ltd. that part of the company's shares held by Lu Keping, the actual controller of the company, have been judicially re-frozen.

*ST Jingfeng Releases Announcement on Abnormal Stock Trading Fluctuations

On the evening of June 11, Hunan Jingfeng Pharmaceutical Co., Ltd. announced that the trading price of the company's stock (Stock Abbreviation: *ST Jingfeng, Stock Code: 000908) had cumulative closing price declines deviating by 12.99% over three consecutive trading days on June 6, 7, and 11, 2024, which falls under the abnormal stock trading fluctuation circumstances stipulated by the "Shenzhen Stock Exchange Trading Rules."

ST Changkang Releases Announcement on Abnormal Stock Trading Fluctuations

On the evening of June 11, Changjiang Runfa Health Industry Co., Ltd. announced that the trading price of the company's stock (Securities Name: ST Changkang; Securities Code: 002435) had fallen for three consecutive trading days (June 6, 2024, June 7, 2024, and June 11, 2024), with the cumulative deviation of closing prices exceeding 12%. According to the relevant provisions of the "Shenzhen Stock Exchange Trading Rules," this constitutes an abnormal fluctuation in stock trading.