Kindstar Global Announces Proposed Acquisition of AnchorDx to Expand into Solid Tumor Early Detection

Sep 23, 2024 16:43 CST Updated 16:43

Ocumension

Ophthalmic Treatment Drug Developer

Johnson & Johnson

Medical Device R&D and Manufacturer

Source: 21st Century Economic Report

Editor: Ji Yuanyuan, Xu Qiulian

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

Policy Trends

Beijing Municipal Medical Products Administration and other 6 departments issued the "Implementation Plan for the Construction of Beijing's Leading Zone for Rare Disease Drug Security (Trial)"

On September 20, the notification regarding the issuance of the "Beijing Implementation Plan for the Construction of a Rare Disease Drug Security Pilot Zone (Trial)" by six departments, including the Beijing Municipal Drug Administration, was released. It pointed out that to fully implement the tasks outlined in the "State Council's Approval of the Work Plan for Supporting Beijing in Deepening the Construction of a Comprehensive Demonstration Zone for Expanding the Opening-Up of National Service Industries" (Guo Han [2023] No. 130), particularly the task of "supporting the establishment of a rare disease drug security pilot zone in Beijing Tianzhu Comprehensive Bonded Area, exploring the import of rare disease drugs not yet registered and marketed in China, with usage guided by specific medical institutions," support will be provided to establish a rare disease drug security pilot zone in Beijing Tianzhu Comprehensive Bonded Area to further meet the clinical medication needs for rare diseases. This plan has been formulated accordingly.

21 Comments: This program aims to explore the establishment of a temporary import facilitation channel for urgently needed medicines for rare diseases in clinical settings, better serving the medication needs of patients with rare diseases. Specifically, the program intends to explore a Beijing model for the guarantee of rare disease medicines, featuring a "whitelist" system in pilot zones, multi-party collaboration, high efficiency and convenience, closed-loop management, and full traceability throughout the process.

Drug and Device Approval

AbbVie's Venetoclax Tablets New Indication Submitted for Marketing Approval in China

On September 20, the CDE website just announced that the new indication application for AbbVie's Venclexta (venetoclax) tablets has been accepted, though the specific indication has not yet been disclosed. Public information indicates that venetoclax, a BCL-2 inhibitor jointly developed by AbbVie and Roche, was previously approved in China for treating adult patients with acute myeloid leukemia (AML). According to the CDE website, this is the third marketing application for venetoclax in China.

Ocumension Submits New Drug Application for Post-Cataract Surgery Inflammation

On September 20, the CDE website showed that the marketing application of Ocumension's dexamethasone implant (OT-502) has been accepted for the treatment of post-cataract surgery inflammation. OT-502 is a novel, biodegradable, single-injection sustained-release anti-inflammatory drug, which can immediately release the active ingredient dexamethasone to exert an anti-inflammatory effect after injection, with a sustained release period of 21-22 days. It is biodegradable and does not require removal.

Johnson & Johnson's EGFR/c-Met Bispecific Antibody Combination with Chemotherapy Receives FDA Approval

On September 20, Johnson & Johnson announced that the FDA had approved its EGFR/c-Met bispecific antibody Rybrevant (amivantamab-vmjw) in combination with standard chemotherapy (carboplatin + pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations and whose disease has progressed during or after treatment with EGFR tyrosine kinase inhibitors (TKIs).

Semaglutide Heart Failure Indication Receives Positive Recommendation from European Regulatory Agency

On September 20, Novo Nordisk announced that 2.4mg Wegovy (semaglutide) received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the treatment of obesity-related heart failure with preserved ejection fraction (HFpEF). This drug is the first GLP-1 medication to be recommended for approval for the treatment of heart failure.

Dongcheng Pharmaceutical's Controlling Subsidiary Lan Nac Cheng Obtains Clinical Trial Approval for 18F-LNC1007 Injection

On September 20, Dongcheng Pharmaceutical announced that its holding subsidiary, Lanafu Cheng, received the clinical trial approval notice for 18F-LNC1007 Injection issued by the National Medical Products Administration. This drug is a novel dual-target radioactive in vivo diagnostic agent intended for diagnosing FAP and αvβ3-positive adult solid tumors.

Capital Market

RNA Startup CAMP4 Therapeutics Files for IPO

On September 20, CAMP4 Therapeutics submitted an application for its initial public offering (IPO) to the U.S. Securities and Exchange Commission (SEC), aiming to raise $75 million (approximately 500 million yuan). The proceeds from this offering will primarily be used for the clinical development of some of its candidate products. According to reports, CAMP4 Therapeutics is dedicated to developing RNA-based regulatory therapies with the goal of upregulating gene expression and restoring healthy protein levels to treat a variety of genetic diseases.

Guizhou Sanli Plans to Acquire 40% Equity of Its Controlling Subsidiary Sankang Partnership for 40 Million Yuan

On September 20, Guizhou Sanli announced that the company plans to acquire 40% of the equity of its controlling subsidiary Sankang Partnership for 40 million yuan in cash. After the transaction is completed, the company will directly and indirectly hold 100% of Sankang Partnership's equity.

ACRO Biosystems Plans to Repurchase 20 Million to 40 Million Yuan Worth of Shares for Cancellation

On September 20, ACROBiosystems announced that the company plans to use its own funds to repurchase some shares through centralized bidding for cancellation and corresponding reduction of registered capital. The total amount of repurchase funds is no less than 20 million yuan and no more than 40 million yuan, with a repurchase price not exceeding 50 yuan per share.

Industry Highlights

Kangsheng Global Plans to Acquire Benchmark Medical

On September 20, "The First Special Inspection Stock in ICL" KSYH announced that it is negotiating to acquire 100% equity of Guangzhou Kangcheng Weiyebiotech Co., Ltd. and AnchorDx Inc., respectively. It is reported that KSYH's acquisition directly points to Baseline Healthcare. On September 21, KSYH stated in a press release that it would acquire 100% equity of Guangzhou Baseline Healthcare Co., Ltd. (hereinafter referred to as "Baseline Healthcare").

Huadong Medicine and Huisun Biologics Reach Exclusive Strategic Cooperation on Commercial Rights for the New Class 1 Drug Proline/Gliflozin Tablets

On September 20, Huadong Medicine announced that its wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd., had reached an exclusive strategic cooperation with Huisheng Biopharmaceutical Co., Ltd., a non-wholly owned subsidiary of Sihe Pharmaceutical Holdings Group Ltd., for the commercial rights in mainland China of its marketed innovative product Huiyoujing (Proline-Gliflozin Tablets). Huiyoujing is an SGLT-2 inhibitor approved for marketing in China by Huisheng Biopharmaceutical for the treatment of type 2 diabetes.

Zhongguancun's Wholly-Owned Subsidiary Plans to Acquire 51% Equity of Gome Internet Hospital for 0 Yuan

On September 20, Zhongguancun announced that its wholly-owned subsidiary Huazutang Elderly Care plans to acquire 51% of the equity in Chengdu Wenjiang Guomei Internet Hospital Co., Ltd., held by its controlling shareholder Guomei Holdings, for 0 yuan. After the completion of this transaction, Huazutang Elderly Care will hold 51% of Guomei Internet Hospital's equity, and Guomei Holdings will hold 49% of the equity. Guomei InternetThe hospital will become a holding subsidiary of Huasutang Elderly Care.

Tebio Biotech and Tengji Pharmaceuticals Sign "Technology Licensing and Development Cooperation Agreement"

On September 20, Tepy Biotech announced that the company had signed a "Technology License and Development Cooperation Agreement" with Tengji Pharmaceuticals, obtaining the exclusive license for NM6606 and related intellectual property rights in China, for the treatment of liver fat metabolism and liver fibrosis-related diseases. According to the agreement, the company will pay an upfront payment of 10 million yuan after the agreement takes effect, development and sales milestone payments of up to 135 million yuan, and royalties based on a certain percentage of annual net sales.