New Indications Approved for AbbVie, Sanofi, and Haisco in China

[February 24, 2022/Medical News Overview] Shanghai suspends the procurement qualification of Xinfeng Pharmaceutical's Rotundine Sulfate Injection for one year; Medtronic announces Q3 financial results for fiscal year 2022; Dongyangguang Pharmaceutical submits a new drug clinical application for HEC169096 tablets... Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Policy Brief

Shanghai Suspends Procurement Qualification for Xinfeng Pharmaceutical's Rotundine Sulfate Injection for 1 Year

On the 24th, the Shanghai Medical Centralized Bidding and Procurement Administration issued a notice regarding the suspension of the procurement qualification for Rotundine Sulfate Injection produced by Guangdong Xinfeng Pharmaceutical Co., Ltd. The notice stated that, according to the relevant provisions of the "Notice on the Comprehensive Implementation of Open Negotiated Pricing for Drug Listing," the procurement qualification for Rotundine Sulfate Injection produced by Guangdong Xinfeng Pharmaceutical Co., Ltd. will be suspended for one year. (Shanghai Medical Centralized Bidding and Procurement Administration)

NMPA Releases "Guiding Opinions on the Applicability Principles of Article 117, Paragraph 2 of the 'Drug Administration Law of the People's Republic of China'"

On the 24th, the NMPA issued an announcement stating that, in order to further standardize the handling of administrative penalty cases related to Chinese herbal decoctions, unify the benchmark for administrative penalties, and lawfully carry out the investigation and punishment of Chinese herbal decoction cases while protecting the lawful rights and interests of citizens, legal persons, and other organizations, the NMPA has organized and formulated the "Guiding Opinions on the Applicability Principles of Article 117, Paragraph 2 of the 'People's Republic of China Pharmaceutical Administration Law'" based on relevant laws and regulations such as the 'Administrative Penalties Law of the People’s Republic of China', the 'Pharmaceutical Administration Law of the People’s Republic of China', and the 'Regulations for the Implementation of the Pharmaceutical Administration Law of the People’s Republic of China'. (NMPA)

Notification on Maintenance of Product Information in the Basic Database for 9 Categories of Medical Consumables Including Indwelling Intravenous Needles Released

Recently, Shenzhen Public Resources Trading Center released the "Notice on the Maintenance of Basic Database Information for 9 Categories of Medical Consumables Including Intravenous Indwelling Needles." The notice stated that, according to the arrangements for centralized bulk procurement of some medical consumables in Guangdong Province, enterprises related to the maintenance of product information in the basic database for 9 categories of medical consumables, including intravenous indwelling needles, which have already been maintained in the Shenzhen Sunshine Platform basic database, must promptly update and maintain the information if there are changes in product registration certificates, specifications, models, materials, etc. The deadline is 17:00 on March 2, 2022. (Shenzhen Public Resources Trading Center)

Industry Economy Observation

Kangtuo Medical's Total Revenue in 2021 was 212 Million Yuan, a Year-on-Year Increase of 29.54%

On the 24th, Contec Medical released its 2021 earnings report, stating that in 2021, the company achieved operating revenue of 212 million yuan, an increase of 29.54% over the same period last year; net profit attributable to the parent company's owners was 81 million yuan, an increase of 55.83% over the same period last year. The net profit attributable to the parent company’s owners after deducting non-recurring gains and losses was 60 million yuan, an increase of 46.34% over the same period last year. (Corporate Announcement)

JOINN Laboratories' Total Revenue in 2021 was 1.51 Billion Yuan, a Year-on-Year Increase of 40.99%

On the 24th, JOINN Laboratories released its 2021 earnings report, stating that the company's total revenue in 2021 was 1.51 billion yuan, a year-on-year increase of 40.99%, and the net profit attributable to shareholders of the listed company was 557 million yuan, a year-on-year increase of 76.83%. (Corporate Announcement)

Heartpulse Medical Achieves Total Revenue of 685 Million Yuan in 2021, Increasing by 45.59% Year-on-Year

On the 24th, Endovastec released its earnings report, showing total operating revenue of 685 million yuan in 2021, a year-on-year increase of 45.59%; net profit attributable to shareholders of the listed company was 316 million yuan, a year-on-year increase of 47.3%. (Company Announcement)

Maiwei Bio's 2021 Net Loss Attributable to Parent Company Reached 7.72 Billion Yuan

On the 24th, Maiwei Biotech released its 2021 annual earnings快报. The company's total operating revenue for 2021 was 16.2262 million yuan, a year-on-year increase of 206.03%. The net profit attributable to the parent company's owner was -7.72 billion yuan, expanding year-on-year. The net profit attributable to the parent company’s owner after deducting non-recurring gains and losses was -7.75 billion yuan, also expanding year-on-year. The basic earnings per share were -2.58 yuan. (Corporate announcement)

Novogene Achieved a Revenue of 1.867 Billion Yuan in 2021, a Year-on-Year Increase of 25.30%

On the 24th, Novogene announced its earnings report, achieving a revenue of 1.867 billion yuan in 2021, a year-on-year increase of 25.30%; net profit reached 225 million yuan, a year-on-year increase of 515.74%. (Corporate Announcement)

Cathay Biotech's Net Profit Increased by 31.89% Year-on-Year in 2021

On the 24th, Cathay Biotech disclosed its earnings快报, achieving a revenue of 2.198 billion yuan in 2021, a year-on-year increase of 46.78%; net profit attributable to shareholders reached 604 million yuan, a year-on-year increase of 31.89%. (Corporate Announcement)

Huitai Medical's Net Profit Increased by 86.47% Year-on-Year in 2021

On the 24th, Huitai Medical disclosed its earnings快报, achieving a revenue of 829 million yuan in 2021, an increase of 72.85% over the same period last year; net profit attributable to shareholders reached 207 million yuan, an increase of 86.47% over the same period last year. (Corporate announcement)

Medtronic Announces Financial Results for the Third Quarter of Fiscal Year 2022

Recently, Medtronic announced its financial results for the third quarter of fiscal year 2022. The net sales for the quarter were $7.763 billion, compared to $7.775 billion in the same period last year; the net profit attributable to the company was $1.48 billion, compared to $1.27 billion in the same period last year, representing a year-on-year increase of 16.5%. By business segment, revenue from the cardiovascular business was $2.745 billion, a year-on-year increase of 1%; revenue from the medical surgical business was $2.29 billion, a year-on-year decrease of 1%; revenue from the neuroscience business was $2.144 billion, a year-on-year increase of 1%; and revenue from the diabetes business was $584 million, a year-on-year decrease of 7%. Revenue from the U.S. region was $3.939 billion, accounting for 50.8% of the company's revenue. (Pharmaceuticals and Healthcare News)

HaiChen Pharmaceuticals Responds to SZSE Concern Letter: Nirmatrelvir API and Formulations Not Authorized by Pfizer

On the 24th, Hachem Pharmaceutical issued an announcement in response to the Shenzhen Stock Exchange's inquiry letter. The company's research on Nirmatrelvir raw materials and preparations has not been authorized by Pfizer. Pfizer’s related raw materials and preparations are protected by patent rights. The company may face legal risks caused by patent infringement, such as the inability to continue the research and application of raw materials, inability to continue the development of preparations, inability to generate sales, and being held liable for infringement after the product is marketed. (Corporate Announcement)

Qianyuan Pharmaceutical: No Use of Voluntary Information Disclosure to Cater to Market Hype and Manipulate Stock Prices

In the morning of the 24th, Qianyuan Pharmaceutical issued an announcement in response to the Shenzhen Stock Exchange's inquiry letter. The "Entrusted Processing Cooperation Agreement" signed by its subsidiary Jiayi Pharmaceutical and Laos Alliance Pharmaceutical Group Co., Ltd., a pharmaceutical company from Laos, is a framework agreement for cooperation between the two parties. The company’s disclosure of the "Entrusted Processing Cooperation Agreement" is driven by the need to substantially advance the entrusted processing and production business, and it does not involve using voluntary information disclosure to cater to market hype or manipulate stock prices. (Corporate Announcement)

Plexium Secures $102 Million to Develop Novel Monovalent Protein Degraders

On the 23rd, Plexium announced the completion of a $102 million financing to develop a new generation of targeted protein degradation therapies. The funds obtained from this financing will enable Plexium to accelerate the advancement of its R&D projects into clinical trials, including a molecular glue that selectively degrades the IKZF2 transcription factor, as well as selective protein degraders targeting CDK2, SMARCA2, and other undisclosed high-value targets. In addition, the funds will also be used to advance Plexium's TPD technology platform. (WuXi AppTec)

Eyebiotech Completes $65 Million Series A Financing to Develop Next-Generation Ophthalmic Therapies

On the 23rd, Eyebiotech announced the completion of a $65 million Series A financing round to protect, restore, and improve vision for patients with ophthalmic diseases. (WuXi AppTec)

Pharmaceutical News and Medical Information

Sanofi/GSK COVID-19 Recombinant Protein Vaccine Phase 3 Clinical Results Announced, Plan to Seek Regulatory Authorization

On the 24th, Sanofi and GlaxoSmithKline announced that they plan to simultaneously submit the Phase 3 efficacy trial data of their jointly developed recombinant protein COVID-19 vaccine and clinical data as a booster shot to seek regulatory approval. Meanwhile, Phase 3 clinical trial data showed that in seronegative populations, two doses of the Sanofi-GSK vaccine were 57.9% effective in preventing symptomatic COVID-19. The vaccine provided 100% protection against severe disease and hospitalization. Early data indicated that the efficacy against symptomatic COVID-19 caused by the Delta variant was 77%. (WuXi AppTec)

Kodiak's Ultra-Long-Acting Anti-VEGF Therapy Fails in Phase IIb/III Clinical Trials

On the 23rd, Kodiak announced that the Phase IIb/III trial of KSI-301 for the treatment of previously untreated neovascular (wet) age-related macular degeneration patients failed to meet the primary efficacy endpoint. The results showed that the visual improvement in the KSI-301 group was inferior to that of aflibercept administered every 8 weeks. A pre-specified secondary analysis evaluating durability in the first year showed that 59% of patients in the KSI-301 group achieved a 5-month dosing interval, with visual improvement and anatomical enhancement comparable to the aflibercept group. (MedCube)

Simcere Pharmaceutical's Trilaciclib Successfully Completes Phase III Clinical Trial in China for Extensive-Stage Small Cell Lung Cancer

On the 23rd, Simcere Pharmaceutical announced that the Chinese Phase III clinical trial for Trilaciclib in treating extensive-stage small cell lung cancer (SCLC) has reached its primary endpoint, demonstrating that Trilaciclib significantly reduces the duration of severe neutropenia in the first cycle among Chinese SCLC patients. This is the world's first and only drug with comprehensive bone marrow protective effects and represents a novel therapy that can reduce chemotherapy-induced myelosuppression. Specific data will be disclosed at subsequent academic conferences. (Medcube)

Ipsen's Montmorillonite Suspension Approved for Marketing in China to Treat Gastrointestinal Diseases

On the 24th, the official website of NMPA announced that the marketing application for Ipsen's New Drug Class 5.1, Montmorillonite Suspension, has been approved. Montmorillonite is an excellent gastrointestinal mucosal protective agent, often used to treat gastrointestinal diseases, such as acute and chronic diarrhea in adults and children. (NMPA)

U.S. FDA Approves Takeda's Takhzyro Single-Dose Prefilled Syringe for Marketing

Recently, Takeda Pharmaceutical announced that the FDA has approved the Takhzyro single-dose prefilled syringe for marketing, to be used in patients aged 12 years and older with hereditary angioedema. (Bioon)

Langnuo Pharmaceutical's Risperidone Oral Solution Type 4 Generic Drug Application Enters "Under Review" Stage

Recently, the Class 4 generic drug application for Risperidone Oral Solution by Shandong Langnuo Pharmaceutical has entered the "under review" stage and is expected to be approved soon for the treatment of acute and chronic schizophrenia, among others. (MENET)

Hailing Pharmaceutical Tranexamic Acid Injection Passes Consistency Evaluation

On the 24th, the NMPA official website updated the approved drug information. The tranexamic acid injection produced by Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical passed the consistency evaluation. It is mainly used for treating various types of bleeding caused by acute or chronic, localized or systemic primary fibrinolysis hyperactivity. (NMPA)

AbbVie's JAK Inhibitor Approved in China for the Treatment of Atopic Dermatitis

On the 24th, the official website of NMPA announced that AbbVie's JAK inhibitor Upadacitinib Sustained-Release has been officially approved in China. According to the priority review announcement by CDE, the indication for which Upadacitinib Sustained-Release Tablets has been approved in China this time is: for adult and adolescent patients aged 12 years and above with moderate to severe atopic dermatitis suitable for systemic treatment. (NMPA)

For the induction and maintenance of general anesthesia! Haisco Pharmaceutical's Ciprofol Injection Approved for the 4th Indication

On the 24th, Haisco announced that its innovative drug Cyclopropofol Injection has been approved by the NMPA for a new indication, used for induction and maintenance of general anesthesia. Public information shows that this is the fourth indication approved for the product in China. (Medicine News)

Sanofi's Anti-Inflammatory Drug Dupixent Approved for New Indication in China

On the 24th, the official website of NMPA announced that Sanofi's new anti-inflammatory drug Dupilumab Injection (Dupixent) has officially received approval for a new indication. According to the priority review disclosure by CDE, the newly approved indication for Dupilumab in China is: for the treatment of moderate to severe atopic dermatitis in children aged 6 years and above but under 12 years, and in adults whose condition is not well controlled by topical prescription drugs or for whom the use of topical prescription drugs is not recommended. (NMPA)

Modern Pharmaceutical's Wholly-Owned Subsidiary API Granted Indian Import License

On the 24th, Modern Pharmaceutical announced that its wholly-owned subsidiary, Sinopharm Weikeda, recently received an import license from the Central Drugs Standard Control Organization of India's Ministry of Health and Family Welfare for active pharmaceutical ingredients. The drugs include Cefotaxime Sodium, Cefuroxime Sodium, and Ceftizoxime Sodium, all of which belong to the β-lactam class of antibiotics. They have the advantages of a broad antibacterial spectrum, strong antibacterial effects, resistance to penicillinase, and fewer allergic reactions compared to penicillins. These are highly effective, low-toxicity, and widely used important antibiotics in clinical settings. (Corporate Announcement)

Dongyangguang Pharmaceutical Submits New Drug Clinical Application for HEC169096 Tablets

On the 23rd, according to the CDE official website, Dongyangguang Pharmaceutical submitted a clinical trial application for the new drug HEC169096 tablets. This is the first clinical application for this product, and the specific target and indications have not been disclosed yet. (CDE)

Treatment of Heart Failure! Salubris Pharma Launches Phase 3 Clinical Trial for ARNI Drug

On the 23rd, the China Drug Clinical Trial Registration and Information Disclosure Platform showed that Salubris Pharmaceuticals has launched a Phase 3 clinical study of S086 tablets for treating patients with heart failure with reduced ejection fraction, planning to enroll 714 patients in China. Public information indicates that S086 tablets are a dual angiotensin II receptor-neprilysin inhibitor independently developed by Salubris, currently under development for two indications: hypertension and chronic heart failure. (China Drug Clinical Trial Registration and Information Disclosure Platform)

For Urticaria! Novartis' New Generation IgE Antibody Therapy Approved for Clinical Trials in China

CDE Official Website Latest Announcement: Novartis' QGE031 Injection Has Obtained Clinical Trial Implied Permission, Targeting the Indication of Chronic Inducible Urticaria. Public Information Shows That QGE031 Is a New Generation of IgE Antibody Therapy, Currently in Phase 3 Clinical Trials Worldwide. (WuXi AppTec)