Hotgen Biotech Supervisor Investigated for Short-Swing Trading; FDA Rejects Roxadustat NDA

【August 12, 2021 / Medical & Pharmaceutical News Digest】Hotgen Biotech Supervisor Placed Under Investigation for Suspected Short-Swing Trading, Junshi Biosciences’ Toripalimab Granted FDA Breakthrough Therapy Designation for First-Line Treatment of Nasopharyngeal Carcinoma, North China Pharmaceutical’s Class 1 New Drug Recombinant Humanized Anti-Rabies Virus Monoclonal Antibody Injection Approved……Daily Latest Pharmaceutical & Medical News: Quick Reads to Keep You Informed!

Part 1 Policy Brief

National Healthcare Security Administration Issues Guiding Opinions on the Medical Insurance Benefits List System

On the 10th, the National Healthcare Security Administration released the 《Opinions on Establishing a Management System for the Healthcare Security Benefit List》. The Opinions point out that, first, regulatory authority will continue to be centralized, while granting local governments a certain degree of flexibility under the premise of safeguarding fundamental rules. Second, coverage will be deepened and benefit levels will be elevated, which will drive the accelerated transformation of the existing medical services and pharmaceuticals and medical consumables markets. （National Healthcare Security Administration）

Part 2: Industry & Economic Observation

Jimin Medical: H1 Net Profit Reaches 105 Million RMB, Up 28-Fold Year-on-Year

On the 12th, Jimin Medical released its 2021 semi-annual report, reporting operating revenue of RMB 534 million, a year-on-year increase of 55.64%; net profit attributable to shareholders of the listed company reached RMB 105 million, up 2,823.67% year-on-year; net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses was RMB 69.4707 million, a year-on-year increase of 427.50%; and basic earnings per share stood at RMB 0.32. (Company Announcement)

Yuwell Medical Releases 2021 Interim Report: Revenue RMB 3.593 Billion, Net Profit RMB 963 Million

On the 11th, Yuwell Medical released its 2021 semi-annual report. In the first half of 2021, Yuwell Medical achieved an operating revenue of RMB 3.593 billion, up 5% year-on-year; the gross profit margin stood at 50.48%, and net profit reached RMB 963 million. (Company Announcement)

Blue Sail Medical: 7.5-billion-unit nitrile glove production line has reached full capacity; the company has recently received some transferred orders.

On the 12th, Blue Sail Medical stated on an investor interactive platform that its 7.5-billion-piece nitrile glove production line has reached full capacity, while its 10-billion-piece nitrile glove production line has been partially completed and put into operation. The company's current capacity utilization rate for nitrile gloves remains at a high level; amid fluctuations in the overseas pandemic situation, the company has recently received some shifted orders. (Cailian Press)

Steven Galson Joins Insilico Medicine as Independent Director

On the 11th, Insilico Medicine announced the appointment of Dr. Steven Galson as an Independent Director of the company. Dr. Galson previously worked at California Biotech, where he served as Senior Director of Research and Development for over a decade, leading global regulatory affairs and drug safety, and recently retired from the company. (PR Newswire)

Weiguang Biotech Director Chen Yong Resigns

On the 12th, Weiguang Biological announced that its Board of Directors recently received a resignation application from Mr. Chen Yong, a Director. Due to a change in his work assignments, he has applied to resign from his positions as Director of the Second Board of Directors and Member of the Strategy Committee. Following his resignation, he will no longer hold any position within the Company. (Corporate Announcement)

Hotgen Biotech Supervisor Under Investigation for Suspected Short-Swing Trading

On the 12th, an announcement from Hotgen Biotech stated that Company Supervisor Han Wei received a "Notice of Case Filing" from the China Securities Regulatory Commission (CSRC) on August 10 due to suspected short-swing trading. The specific amount involved in the suspected short-swing trading has not yet been determined and will be subject to the CSRC's investigation results. (Corporate Announcement)

Buchang Pharmaceuticals' Controlled Subsidiary Shanghai Hepu Completes Change Registration of Medical Device Operation License

On the 12th, Buchang Pharmaceuticals announced that its controlled subsidiary, Shanghai Hepu, recently obtained a renewed "Medical Device Operation License" issued by the Shanghai Jinshan District Administration for Market Regulation. (Company Announcement)

Part 3: Medical & Pharmaceutical News

Junshi Biosciences’ Toripalimab Receives FDA Breakthrough Therapy Designation for First-Line Treatment of Nasopharyngeal Carcinoma

On the 12th, Junshi Biosciences announced that its product toripalimab in combination with gemcitabine/cisplatin has recently been granted Breakthrough Therapy Designation by the U.S. FDA as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma. (Company Announcement)

North China Pharmaceutical's Class 1 New Drug Recombinant Humanized Anti-Rabies Virus Monoclonal Antibody Injection Approved

On the 12th, the NMPA released information regarding the availability of drug approval notices for collection. The announcement stated that the Class 1 new drug, Recombinant Human Anti-Rabies Virus Monoclonal Antibody Injection, developed by North China Pharmaceutical, has been approved. Its mechanism of action and indication are for use in combination with human rabies vaccine to bridge the antibody gap during the active immunization process, directly neutralize the rabies virus in vivo, and provide passive immunity. It is indicated for passive immunization in patients who have been bitten or scratched by rabid or other rabies virus-susceptible animals. (NMPA)

Hengrui Pharma: Long-Acting Antifungal Drug HRS9432 for Injection Approved for Clinical Trials

On the 12th, Hengrui Medicine announced that its subsidiary, Fujian Shengdi Medicine, recently received the 《Notice of Approval for Drug Clinical Trials》 approved and issued by the NMPA for HRS9432 for Injection, and will commence clinical trials in the near future. HRS9432 for Injection is intended for the prevention and treatment of candidemia and/or invasive candidiasis. (Corporate Announcement)

Innovent PCSK9 Monoclonal Antibody Phase III Trial for Heterozygous Familial Hypercholesterolemia in China Successful

On the 12th, Innovent Biologics announced that its Phase III clinical trial of the PCSK9 monoclonal antibody IBI-306 for the treatment of heterozygous familial hypercholesterolemia in China met its primary endpoint. (PharmaCube)

I-Mab Biopharma Announces Interim Results from Phase 2/3 Clinical Trial for Severe COVID-19 Treatment

On the 11th, I-Mab announced that the Phase 2/3 study of plonmarlimab for the treatment of cytokine release syndrome associated with severe COVID-19 has yielded positive interim results. Plonmarlimab is an anti-GM-CSF neutralizing antibody that potently neutralizes GM-CSF, blocking the excessive activation of the immune system upstream in the inflammatory cytokine network pathway, thereby mitigating severe complications in COVID-19 patients such as pulmonary and other organ damage. (BioExplorer)

FDA Approves Keytruda/Lenvima Combination Therapy for First-Line Treatment of Advanced Renal Cell Carcinoma

On the 12th, Merck & Co. and Eisai announced that the FDA has approved the combination of the anti-PD-1 therapy Keytruda and the oral multi-receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma. (Jike Yaowen)

FDA Refuses to Approve Roxadustat for Marketing

On the 11th, FibroGen announced receipt of a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia associated with chronic kidney disease. The letter stated that the FDA will not approve the NDA for roxadustat at this time and has requested FibroGen to conduct additional clinical studies on roxadustat prior to resubmitting a marketing application. (PharmCube)

Baili Pharmaceutical Submits Application for Its First Novel ADC Drug

On the 10th, the NMPA accepted the clinical trial application for BL-B01D1 from Biokin Pharma. According to information on Biokin’s official website, based on its R&D code, BL-B01D1 is likely an antibody-drug conjugate (ADC), though its specific target(s) remain undisclosed. (NMPA)

Aosaikang's New PPI Drug Set for Approval

Recently, the marketing application for dexlansoprazole for injection, a Class 2.2 new drug from Aosaikang Pharmaceutical, has entered the "under review" status. Dexlansoprazole is a proton pump inhibitor and the R-enantiomer of lansoprazole. (NMPA)

69 Medical Consumables in Liaoning Province Voluntarily Reduce Prices

On the 11th, the Liaoning Provincial Drug and Medical Consumables Centralized Procurement Network issued the 《Notice on the Implementation of PTA Balloon Catheters, etc.》. The 《Notice》 states that the Liaoning Provincial Public Resources Trading Center has received applications for the voluntary price reduction of 69 consumable products in Liaoning Province, submitted by Stryker Medical, Yuefengda Medical, and Fresenius Medical Products. It has approved the adjustment of the platform-listed procurement prices for the aforementioned products. All medical and health institutions across the province shall implement the new listed procurement prices effective from 00:00 on August 14. （Liaoning Provincial Drug and Medical Consumables Centralized Procurement Network）

Unicondylar Knee Prosthesis Approved for Market Launch

On the 10th, following review, the NMPA approved the registration of the innovative product "unicompartmental knee prosthesis" manufactured by Beijing Chunli Zhengda Medical Device Co., Ltd. The product is indicated for unicompartmental knee replacement, effectively treating unicompartmental knee disease and successfully restoring lower limb alignment. (NMPA)

Linka Therapeutics' Triple Kinase Inhibitor LNK01002 Completes First Patient Dosing in Phase I Clinical Trial

On the 12th, Linko Pharmaceuticals announced that the first patient has been dosed in China in the Phase I clinical study of its triple-kinase inhibitor, LNK01002. LNK01002 is an innovative triple-kinase inhibitor independently developed by Linko Pharmaceuticals that can effectively target three driver kinase targets simultaneously, with the potential to treat patient populations refractory or resistant to conventional therapies. (PR Newswire)

First Patient Dosed in Phase II Clinical Trial of Alphamab Oncology's KN026 for HER2-Positive Breast Cancer

On the 12th, Alphamab Oncology announced that the Phase II clinical trial of its independently developed HER2 bispecific antibody KN026 for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer recently completed the first patient dosing. (PR Newswire)

INDICAID™ Tuoxi™ Receives U.S. FDA Emergency Use Authorization

On the 11th, Profound Medical announced that its INDICAID™ SARS-CoV-2 Rapid Antigen Test Kit received Emergency Use Authorization (EUA) from the U.S. FDA on July 29, 2021, becoming the first rapid antigen test product in Greater China to receive such authorization. (PR Newswire)

Contec Medical Exercise Stress ECG Monitor Receives Medical Device Registration Certificate

On the 11th, Contec Medical announced that the company has recently obtained the Medical Device Registration Certificate for an exercise stress ECG monitoring device, intended for the real-time monitoring of patients' electrocardiogram (ECG) changes during exercise. (Company Announcement)

Innovative Oral Therapy for Hemoglobinopathies Achieves Clinical Proof of Concept

Fulcrum Therapeutics announced today that its investigational therapy FTX-6058 has achieved positive interim results from a Phase 1 single and multiple ascending dose clinical trial in healthy adult volunteers. FTX-6058 is a potent and selective small-molecule EED inhibitor that targets a novel epigenetic target to increase fetal hemoglobin expression, with the potential to treat various hemoglobinopathies. (WuXi AppTec)

Reduces Liver Injury-Related Markers: Positive Early Clinical Results for Innovative NASH Therapy

On the 10th, CohBar announced that its mitochondria-derived peptide drug CB4211 met its primary endpoint in a Phase 1a/1b clinical trial conducted in patients with nonalcoholic steatohepatitis and obesity. (WuXi AppTec)

WHO Launches Global Clinical Trial Testing Repurposed Drugs Such as Artesunate and Gleevec for COVID-19

On the 11th, the WHO announced that its global clinical trial, Solidarity, will advance to its next phase—the Solidarity PLUS trial. This trial will evaluate the efficacy of three approved drugs—artesunate, imatinib, and infliximab—in hospitalized COVID-19 patients. Previous studies have shown that they hold the potential to reduce the risk of death among hospitalized COVID-19 patients. (WuXi AppTec)