TG Therapeutics Voluntarily Withdraws BLA/sNDA for Ukoniq (umbralisib) in CLL/SLL Following Updated OS Data from UNITY-CLL Trial

[April 19, 2022/Medical News Overview] Xingqi Eye Drops: 2021 net profit increased by 121.31% year-on-year; Lifang Pharmaceutical: 2021 net profit of approximately 172 million yuan, a year-on-year increase of 27.47%; K drug combination therapy for high-risk early-stage TNBC adult patients approved for neoadjuvant treatment in Canada... Daily fresh pharmaceutical news and medical information, Speed Reading Society keeps you updated!

Policy Brief

National Healthcare Security Administration: Ensure the Smooth Transition and Use of the DRG/DIP Function Module in the Payment Management Subsystem

Recently, the National Healthcare Security Administration issued the "Notice on Doing a Good Job in the Connection of the DRG/DIP Function Module of the Payment Method Management Subsystem," announcing that to further the reform of DRG/DIP payment methods, the administration has developed a basic version of the DRG/DIP function module based on a unified national healthcare security information platform. Provinces across China should follow relevant regulations to ensure the nationwide implementation and application of the DRG/DIP function module. (National Healthcare Security Administration)

Beijing Municipal Health Commission Responds to the Suspension of Jingyitong

On the 19th, the Beijing Municipal Health Commission responded to the matter, stating that Beijing Yihe Chun Tian Technology Co., Ltd., the operator of the online system for Jingyitong, had a dispute with the funding and construction party, Beijing Bank Co., Ltd. The Beijing Municipal Health Commission and the Beijing Hospital Management Center had previously taken note of the situation and were guiding the parties involved to resolve the dispute proactively. On the evening of April 18, a notice of suspension from Beijing Yihe Chun Tian Technology Co., Ltd. circulated online. The Beijing Municipal Health Commission and the Beijing Hospital Management Center have urgently notified both parties and will further urge and guide them to resolve the dispute legally and rationally, prioritizing public interest, so that the general public can continue to access convenient online appointment services. (Beijing Municipal Health Commission)

Over 50,000 Consumables Delisted in Shaanxi

Recently, the Shaanxi Provincial Public Resources Trading Center released the "Announcement on Revoking the Online Listing Qualification of Products Without Filling in the National Uniform Medical Insurance Information Code." Among them, more than 50,000 medical consumables were delisted due to failure to fill in the national uniform medical insurance information code or having duplicate and incomplete codes. These include arm abduction fixators, ultrasonic scalpel heads for ultrasonic high-frequency surgical integrated systems, locking intramedullary nails, balloon dilation catheters, hip joint prostheses, etc. (Shaanxi Provincial Public Resources Trading Center)

Industry Observation

Foce Pharma Director Du Xiaozheng Resigns

On the 18th, Focare Pharmaceutical announced that the board of directors received a written resignation report from director Du Xiaozheng on April 15. Du Xiaozheng applied to resign from the positions of company director and member of the strategic committee due to work reasons. After resignation, he will no longer hold any position in the company or its subsidiaries, and the resignation report will take effect upon delivery to the board of directors. (Corporate Announcement)

Runda Medical Director Yan Chunhua Resigns

RunDa Medical announced today that the company's board of directors recently received a written resignation report from director Mr. Yan Chunhua: Mr. Yan Chunhua intends to resign from his positions as a director and member of the Compensation and Evaluation Committee due to work adjustment reasons. After his resignation, Mr. Yan Chunhua will no longer hold any position in the company. As of the date of this announcement, Mr. Yan Chunhua does not hold any shares of the company. (Corporate Announcement)

Shanghai Hengyi Medical Equipment Co., Ltd. Suspected of Price Gouging Has Been Investigated

Today's news: The law enforcement team of the Shanghai Market Supervision Administration investigated Shanghai Hengyi Medical Device Co., Ltd. for suspected price gouging of 11 types of epidemic prevention products sold during the pandemic based on online inspection clues. The investigation revealed that in group-buying orders from April 12 to April 16, the markup rates for seven products sold by the company—75% alcohol, 84 disinfectant, medical hand sanitizer, disinfectant effervescent tablets, medical gloves, protective face shields, and N95 masks—all exceeded the highest markup rate for the same products within the seven days prior to or on March 19, 2022. The aforementioned actions of the company are suspected of constituting price gouging, and an investigation has been initiated. The market supervision department will handle the case strictly, severely, and swiftly according to price regulation laws and regulations. (Cailian Press)

Roche Pharmaceuticals China and Teva Pharmaceuticals Reach Innovative Strategic Cooperation

On the 8th, Roche Pharmaceuticals China announced a cooperation agreement with Teva. The two parties will combine their respective advantageous resources to further expand the patient accessibility of the original drug Bendamustine Hydrochloride in China. Through this cooperation, Roche China will further enrich its product pipeline in the field of hematological tumors, expand the overall landscape of lymphoma treatment, and continue to work with all parties to promote standardized lymphoma diagnosis and treatment in China. (MedView)

Sinovac Biotech's Net Profit in 2021 was 96.4639 Million Yuan, a Year-on-Year Decrease of 30.67%

On the 19th, Sinovac Pharmaceutical released its 2021 annual report. During the reporting period, the company achieved operating revenue of 1,285,171,728.90 yuan, a year-on-year increase of 5.32%; net profit attributable to shareholders of the listed company was 96,463,914.26 yuan, a year-on-year decrease of 30.67%. (Corporate Announcement)

Xingqi Eye Drops: 2021 Net Profit Increased by 121.31% Year-on-Year

Today, Xingqi Eye Medicine disclosed its 2021 annual report. During the reporting period, the company achieved operating revenue of 1.028 billion yuan, an increase of 49.26% over the same period last year; net profit attributable to shareholders of listed companies was 195 million yuan, an increase of 121.31% over the same period last year; basic earnings per share were 2.39 yuan. The company plans to distribute a cash dividend of 4.00 yuan (including tax) for every 10 shares to all shareholders. (Corporate Announcement)

Will Pharmaceutical: Net profit of 101 million in 2021, up 0.92% year-on-year

On the 18th, Will Pharma released its 2021 annual report. During the reporting period, the company achieved operating revenue of 1,042,305,915.97 yuan, a year-on-year increase of 41.61%; net profit attributable to shareholders of listed companies was 101,370,204.55 yuan, a year-on-year increase of 0.92%. (Corporate Announcement)

Cube Pharmaceutical: Net Profit of Approximately 1.72 Billion Yuan in 2021, a Year-on-Year Increase of 27.47%

On the evening of August 18, Lifang Pharmaceutical released its annual earnings report, stating that in 2021, the company's revenue was approximately 2.273 billion yuan, an increase of 20.01% year-on-year; net profit attributable to shareholders of the listed company was about 172 million yuan, an increase of 27.47% year-on-year; basic earnings per share were 1.86 yuan, a year-on-year decrease of 4.12%. (Corporate Announcement)

Saintsure Biotech's Net Profit in 2021 was 2.243 Billion Yuan, a Year-on-Year Decrease of 14.29%

On the 19th, SaintSure Biotech released its 2021 annual report. During the reporting period, the company achieved operating revenue of 4,514,539,266.46 yuan, a year-on-year decrease of 5.22%; net profit attributable to shareholders of listed companies was 2,242,696,395.58 yuan, a year-on-year decrease of 14.29%. (Corporate Announcement)

Tonghua Dongbao: 2021 Net Profit of 1.308 Billion Yuan, Up 40.69% Year-on-Year

On the evening of August 18, Tonghua Dongbao disclosed its annual report. The company achieved operating revenue of 3.268 billion yuan in 2021, representing a year-on-year increase of 12.99%; net profit attributable to shareholders of 1.308 billion yuan, up 40.69% year-on-year; basic earnings per share of 0.64 yuan; proposed cash dividend of 3.00 yuan (including tax) for every 10 shares. Regarding the reasons for the changes in performance, Tonghua Dongbao stated that the steady growth in human insulin sales and the rapid increase in glargine insulin were the main drivers of performance during the reporting period. (Corporate Announcement)

Salubris: Q1 Net Profit of 237 Million Yuan, Up 53.09% Year-on-Year

On the 18th, Salubris announced its Q1 2022 report, with operating revenue reaching 935 million yuan, a year-on-year increase of 22.11%; net profit attributable to shareholders was 237 million yuan, increasing by 53.09% year-on-year; basic earnings per share were 0.22 yuan. (Corporate Announcement)

Kelon Pharmaceutical: Q1 Net Profit Increased by 66.09% Year-on-Year

On the 18th, Kelun Pharmaceuticals disclosed the Q1 2022 earnings report. The company achieved a total operating revenue of 4.482 billion yuan, representing a year-on-year increase of 7.97%; the net profit attributable to shareholders reached 291 million yuan, marking a year-on-year increase of 66.09%. (Corporate Announcement)

Chison Medical: Q1 Net Profit of 24.852 Million Yuan, Up 9.05% Year-on-Year

On the 18th, Xiangsheng Medical released its Q1 2022 report, achieving revenue of 100 million yuan, a year-on-year increase of 23.04%; net profit attributable to shareholders was 24.852 million yuan, a year-on-year increase of 9.05%; basic earnings per share were 0.31 yuan. (Corporate Announcement)

Staidson: Loss of 24.4095 Million in Q1 2022, Increased Year-on-Year Loss

On the 19th, Staidson released its Q1 2022 report, stating that during the reporting period, the company achieved operating revenue of 123,340,760.08 yuan, a year-on-year increase of 6.83%; the net profit attributable to shareholders of the listed company was -24,409,475.07 yuan, representing an increase in loss compared to the same period last year. (Corporate Announcement)

Pharmaceutical News and Medical Information

K Drug Combination Therapy Approved in Canada for Neoadjuvant Treatment of High-Risk Early-Stage TNBC in Adult Patients

Recently, Merck announced that Health Canada has approved the anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemotherapy for adjuvant treatment of adult patients with high-risk early-stage triple-negative breast cancer. Additionally, Keytruda can also be used as a monotherapy for adjuvant treatment after surgery. (Sina Medicine News)

Stemirna Therapeutics' CAR-T Product Granted FDA Fast Track Designation

On the 19th, Sidansai Biotechnology announced that the U.S. FDA had granted GCC19CART Fast Track designation. GCC19CART is an autologous CAR-T therapeutic product targeting GCC, developed by Sidansai Biotechnology for the treatment of recurrent, refractory, metastatic colorectal cancer as a solid tumor therapy. (MedView)

Haisco: Fat Emulsion Amino Acids (17) Glucose (11%) Injection Passes Generic Drug Consistency Evaluation

On the 19th, Haisco announced that its subsidiary Liaoning Haisco's drug Fat Emulsion Amino Acids (17) Glucose (11%) Injection has passed the quality and efficacy consistency evaluation for generic drugs. This product is used for adult patients who cannot or have insufficient function or are contraindicated for oral/enteral nutrition intake. (Corporate Announcement)

Kingstron Bio Cardiac Surgery Biological Patch Approved for Marketing in China

On the 18th, Kingstron Bio announced that its self-developed cardiac surgery biological patch, Elite Air, received certification from the China National Medical Products Administration, approving it for market sale to repair ventricular septal defects in cardiac surgeries. (MedView)

SAL007 Clinical Trial Application for HFpEF Drug by Sinopharm Care Accepted

On the 19th, Salubris announced that the clinical trial application for the drug Recombinant Human Neuregulin 1-Anti-HER3 Antibody Fusion Protein Injection (Project Code in China: SAL007) has been accepted. The application submitted by the company this time is for the Phase I clinical trial of SAL007 for the HFpEF (Heart Failure with Preserved Ejection Fraction) indication in chronic heart failure. (Corporate Announcement)

Junshi Biosciences' COVID-19 Oral Drug VV116 Can Be Used to Treat RSV Infection

Recently, Junshi Biosciences announced that the preclinical in vivo efficacy research results of VV116 tablets, an oral nucleoside antiviral drug against SARS-CoV-2 developed in collaboration with Wangshan Wangshui, were published online in *Signal Transduction and Targeted Therapy*, a journal under *Nature*. The study found that VV116 demonstrated excellent antiviral effects on multiple RSV-sensitive cell lines. (Corporate Announcement)

Amgen Biosimilar ABP 654 Phase III Clinical Trial Successful

Recently, Amgen announced preliminary results from a Phase 3 clinical study. This was a multicenter, randomized, double-blind, comparative clinical trial conducted in adult patients with moderate to severe plaque psoriasis, evaluating the efficacy and safety of biosimilar ABP 654 compared to Stelara. The results showed that the study met its primary efficacy endpoint: there was no clinically meaningful difference between ABP 654 and Stelara. This preliminary assessment analyzed the percentage improvement in the Psoriasis Area and Severity Index (PASI) from baseline to Week 12 of treatment. The data indicated that the mean difference in PASI improvement percentage between ABP 654 and Stelara was 0.14, within the pre-specified margin. (Sina Medicine News)

The World's First PI3Kδ/CK1ε Inhibitor Withdraws Its Marketing Application

On the 15th, TG Therapeutics announced the voluntary withdrawal of the Biologics License Application/Supplemental New Drug Application for the U2 combination of Ukoniq (umbralisib) and ublituximab for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. This decision to withdraw was based on the recently updated overall survival data from the Phase III UNITY-CLL trial. (PharmaCube)

Haisco BTK Protein Degrader Approved for Clinical Trials in the United States

On the 18th, Haisco announced that the US IND application for its BTK protein degrader HSK29116 has been approved by the FDA. This clinical trial will evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of the drug in subjects with relapsed or refractory B-cell malignancies. HSK29116 is currently undergoing dose escalation trials in China and Australia. In a press release, Haisco stated that HSK29116 is the first BTK-PROTAC drug in China and the second globally to enter clinical research. (MedView)

BeiGene TYK2 Inhibitor Clinical Trial Initiated in China

Recently, according to the Insight database, BeiGene has initiated the clinical trial of TYK2 inhibitor BGB-23339 in China for the first time. On November 22 last year, the Phase 1 clinical trial of BGB-23339 abroad had already completed the first patient dosing. (Insight Database)

Bioturbo's COVID-19 Antigen Self-Test Kit Obtains Medical Device Registration Certificates in Brazil and Myanmar

On the 19th, Bioturbo Biologics announced that its COVID-19 antigen self-test kit has obtained medical device registration certificates or production and sales licenses in Brazil and Myanmar. (Corporate Announcement)