Dapagliflozin First Generic Approved in China; Multiple Pharma Companies Release Q3 Financial Results

【October 29, 2021 / Medical & Pharmaceutical News Roundup】Shanghai Pharmaceuticals licenses overseas rights to SPH6162 to HUYABIO for up to USD 292.5 million; MSD reports Q3 sales of USD 13.154 billion, up 20% year-on-year; AbbVie's innovative infusion therapy meets Phase 3 clinical endpoints.……Daily Latest Pharma & Medical News, Quick Read—Stay Informed With Us!

Part 1 Policy Brief

NMPA Revises Labeling for Zoledronic Acid Injection

On the 28th, based on the assessment results of adverse drug reactions and to further ensure public medication safety, the NMPA has decided to uniformly revise the package insert for zoledronic acid injection. Where the revisions involve drug labels, they shall be revised accordingly; other contents of the package insert and labels shall remain consistent with the originally approved content. For drugs manufactured on or after the filing date, the original package insert shall no longer be used. The Marketing Authorization Holder shall replace the package inserts and labels of drugs already distributed within 9 months following the filing. (NMPA)

NMPA Issues "Rules for the Classification of In Vitro Diagnostic Reagents"

On the 29th, in accordance with the work deployment for revising the supporting rules and normative documents of the 《Regulations on the Supervision and Administration of Medical Devices》, the NMPA separated the content concerning the classification of in vitro diagnostic (IVD) reagents from Order No. 5 to formulate an independent 《Rules for the Classification of In Vitro Diagnostic Reagents》, which shall take effect from the date of promulgation to standardize the classification management of IVD reagents. (NMPA)

Registration Certificates for 2 Medical Device Products Cancelled

On the 29th, NMPA announced that, pursuant to applications submitted by the enterprises and in accordance with the requirements of the "Procedures for Voluntary Cancellation of Medical Device Registration Certificates," the Medical Device Registration Certificates for the following two products are hereby cancelled: the Peripheral Vascular Balloon Dilatation Catheter manufactured by Shanghai Kinetic Medical Technology Co., Ltd., and the Balloon Dilatation Catheter manufactured by Tokai Medical Products Inc. (NMPA)

Part 2: Industry Insights

Up to $292.5 Million! Shanghai Pharma Licenses Overseas Rights of SPH6162 to HUYABIO

On the 29th, Shanghai Pharma announced that it recently entered into an exclusive license agreement with HUYABIO INTERNATIONAL LLC. For a transaction value of up to USD 292.5 million, Shanghai Pharma will exclusively license to HUYABIO, for consideration, the rights to manufacture, use, sell, import, develop, and commercialize SPH6162, which possesses proprietary intellectual property rights, outside the China region. All relevant rights and interests pertaining to SPH6162 within China will remain with Shanghai Pharma. (Company Announcement)

Anglikang and Hanwei Medical Sign Strategic Cooperation Agreement in Medical Devices and Medical Aesthetics

On the 28th, Anglikang announced that it has signed a strategic cooperation agreement with Hanwei Medical to jointly develop the medical device and medical aesthetics sectors. The company intends to invest no more than RMB 20 million from its own funds to acquire an equity stake of no less than 25% in Hanwei Medical. (Company Announcement)

ZJ Biotech: Q3 Net Profit of 216 Million RMB, Down 19% Year-on-Year

On the 28th, Zhijiang Bio announced that its operating revenue for the third quarter reached RMB 574 million, down 4.34% year-on-year; net profit attributable to shareholders of the listed company was RMB 216 million, a year-on-year decrease of 19.33%. (Corporate Announcement)

Cathay Biotech: Q3 Net Profit RMB 164 Million, Up 42% YoY

On the 28th, Cathay Biotech announced that its operating revenue for the third quarter reached RMB 618 million, representing a year-on-year increase of 72.37%; net profit attributable to shareholders of the listed company amounted to RMB 164 million, up 42.41% year-on-year. (Company Announcement)

Jiuzhou Pharmaceutical: Third Quarter Net Profit RMB 198 Million, Up 80.39% Year-on-Year

On the 28th, Jiuzhou Pharmaceutical announced that its operating revenue for the third quarter reached RMB 1.136 billion, representing a year-on-year increase of 53.97%; net profit attributable to shareholders of the listed company amounted to RMB 198 million, up 80.39% year-on-year; net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses stood at RMB 191 million, a year-on-year increase of 111.40%; and basic earnings per share was RMB 0.24. (Company Announcement)

WuXi AppTec: Q3 Net Profit RMB 887 Million, Up 36.23% Year-on-Year

On the 29th, WuXi AppTec announced that its third-quarter net profit reached 887 million yuan, a year-on-year increase of 36.23%. The net profit for the first three quarters totaled 3.562 billion yuan, up 50.41% year on year. (Company Announcement)

MSD Q3 Sales: $13.154 Billion, Up 20% Year-Over-Year

On the 28th, MSD reported Q3 sales of $13.154 billion, up 20% year-over-year; GAAP net income was $4.567 billion, up 55% year-over-year. (Company Announcement)

Changchun High-Tech: Q3 Net Profit RMB 1.224 Billion, Up 28.78% Year-on-Year

On the 29th, Changchun High-Tech announced that its net profit for the third quarter reached RMB 1.224 billion, representing a year-on-year increase of 28.78%. Net profit for the first three quarters stood at RMB 3.147 billion, up 39.25% year on year. (Corporate Announcement)

Yifeng Pharmacy: Q3 Net Profit RMB 191 Million, Up 11.7% Year-on-Year

On the 29th, Yifeng Pharmacy announced that in the third quarter, the company recorded operating revenue of RMB 3.592 billion, a year-on-year increase of 14.24%; net profit attributable to the parent company was RMB 191 million, up 11.70% year-on-year; net profit attributable to the parent company after deducting non-recurring gains and losses was RMB 188 million, up 13.65% year-on-year; and basic earnings per share was RMB 0.27. (Company Announcement)

Hisun Pharmaceutical: Q3 Net Profit RMB 499 Million, Up 115% Year-on-Year

On the 29th, Hisun Pharmaceutical announced that its operating revenue for the first three quarters of 2021 reached RMB 9.107 billion, up 11.69% year-on-year; net profit stood at RMB 499 million, up 45.83% year-on-year. Net profit for the third quarter was RMB 219 million, up 115.37% year-on-year. (Company Announcement)

Jumpcan Pharmaceutical: Q3 Net Profit RMB 418 Million, Up 52.16% Year-on-Year

On the 29th, Jichuan Pharmaceutical announced that revenue for the first three quarters reached RMB 5.409 billion, up 25.39% year-on-year; net profit was RMB 1.272 billion, up 32.56% year-on-year; net profit in the third quarter reached RMB 418 million, up 52.16% year-on-year. (Company Announcement)

Part 3: Pharmaceutical and Medical News

Effective Relief Lasting Up to 6 Months! Microbiome Therapy Shows Promise in Reducing Recurrent Clostridioides difficile Infections

Recently, Ferring Pharmaceuticals and its subsidiary Rebiotix presented key retrospective analysis results for RBX2660 at the 2021 American College of Gastroenterology (ACG) Annual Scientific Meeting. The findings pertained to the use of RBX2660 for recurrent *Clostridioides difficile* infection (rCDI) and inflammatory bowel disease (IBD). Among 94 patients with recurrent CDI and common comorbidities treated with RBX2660, 82.8% showed no recurrence of CDI at 8 weeks post-administration, with no difference observed between patients receiving a single dose and those receiving two doses. In the cohort that achieved clinical remission after the first dose, 88.7% sustained clinical remission for up to 6 months. (BioShell)

Overcoming Limitations of Oral Parkinson's Disease Therapies, AbbVie's Innovative Infusion Therapy Meets Phase 3 Clinical Endpoints

On the 28th, AbbVie announced that ABBV-951, an investigational therapy for Parkinson’s disease, met its primary endpoint in a pivotal Phase 3 clinical trial. Trial results showed that at Week 12, the ABBV-951 group experienced a 2.72-hour increase in “Good On” time, compared to a 0.97-hour increase in the oral medication group. Improvements in patients’ “Good On” time were observed in the ABBV-951 group as early as Week 1 and were sustained throughout the 12-week treatment period. Additionally, the trial demonstrated an improvement from baseline in the average troublesome “Off” time; after 12 weeks of treatment, “Off” time was reduced by 2.75 hours in the ABBV-951 group and by 0.96 hours in the oral medication group. (WuXi AppTec)

First Patient Dosed in Registration Clinical Trial of Alphamab Oncology’s KN046 for the Treatment of Non-Small Cell Lung Cancer

On the 29th, Alphamab Oncology announced that the first patient has been dosed in a registration clinical study of KN046, a PD-L1/CTLA-4 bispecific antibody, conducted in China. ENREACH-LUNG-02 is a multicenter, randomized, open-label, active-controlled Phase II/III clinical study. The Phase III portion will be conducted at approximately 50 centers and plans to enroll approximately 486 patients. With overall survival (OS) and progression-free survival (PFS) as co-primary endpoints, the study will compare the efficacy of KN046 in combination with lenvatinib versus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression after prior anti-PD-(L)1 therapy. (PR Newswire)

Locus Medical's RM-1929 Demonstrates Positive Efficacy in Treating Head and Neck Squamous Cell Carcinoma

Recently, Rakuten Medical announced that data from a Phase 1/2a open-label, multicenter study evaluating photoimmunotherapy RM-1929 in patients with locoregionally recurrent head and neck squamous cell carcinoma have been published in *Head and Neck*. For patients enrolled in Part 2 of the study, the median overall survival was 9.30 months. Thirteen patients achieved confirmed and unconfirmed objective responses, with four achieving complete responses and nine showing partial responses. Disease control was observed in 24 patients. (Bioon)

Alnylam Announces New 18-Month Data for Investigational RNAi Therapy Vutrisiran in the Treatment of hATTR-PN

Recently, the company announced positive 18-month results from the Phase 3 HELIOS-A study of vutrisiran. Vutrisiran is an investigational RNA interference (RNAi) therapy administered via subcutaneous injection once every three months for the treatment of adults with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN). Previously, the study met its primary endpoint and all secondary endpoints at the 9-month timepoint. The latest results released demonstrate that the study met all secondary endpoints assessed at the 18-month timepoint: compared with external placebo data from the Phase 3 APOLLO study of the RNAi drug Onpattro, vutrisiran treatment resulted in statistically significant improvements in neuropathy impairment, quality of life, gait speed, nutritional status, and overall disability. Regarding the final secondary endpoint, as expected, the vutrisiran treatment group demonstrated non-inferiority to the Onpattro treatment group in the study with respect to the reduction in serum transthyretin (TTR) levels. (Bioon)

BGI's Wholly-Owned Subsidiary Secures Indian Import License for Non-Invasive Prenatal Testing Product

On the 29th, BGI Genomics announced that non-invasive prenatal testing (NIPT) related products manufactured by its wholly-owned subsidiary, Wuhan BGI Biotechnology, recently obtained an import license issued by India's Central Drugs Standard Control Organisation (CDSCO). Clinically, these products are primarily used for the screening of congenital genetic diseases such as Down syndrome. (Company Announcement)

Huasen Pharmaceutical's Chayu Capsules Receives Notice of Approval for Supplemental Drug Application

On the 29th, Huasen Pharmaceutical announced that it recently received the “Approval Notice for Supplementary Application for Drug Registration” regarding Chayu Capsules, approved and issued by the NMPA. This marks the completion of the Marketing Authorization Holder (MAH) change for the product, with the company officially becoming its MAH. The company will promptly commence marketing activities. Chayu Capsules are indicated for asthmatic bronchitis, chronic bronchitis, and bronchial asthma. (Corporate Announcement)

Two of Medprin's Products Receive "Acceptance Notice" for Medical Device Registration Application

On the 29th, Medprin Medical announced that its two products, the Patient-Specific PEEK Craniomaxillofacial Repair System and the Absorbable Medical Adhesive, recently received the "Notice of Acceptance" for medical device registration applications issued by the NMPA. The Patient-Specific PEEK Craniomaxillofacial Repair System, used in conjunction with a craniomaxillofacial internal fixation system, is indicated for the repair of craniomaxillofacial bone defects; the Absorbable Medical Adhesive is used for the adjunctive sealing of the dura (spinal) mater during neurosurgical procedures to prevent cerebrospinal fluid leakage. (Company Announcement)

Sinopharm Modern Obtains Overseas Marketing Authorization for Ceftriaxone Sodium for Injection

On the 29th, Sinopharm Modern announced that its indirectly controlled subsidiary, DALI Pharma, has received a marketing authorization for Ceftriaxone Sodium for Injection, approved and issued by the Malta Medicines Authority. The product is indicated for the treatment of bacterial meningitis, community- and hospital-acquired pneumonia, abdominal infections, complicated urinary tract infections, bone and joint infections, skin and soft tissue infections, syphilis, and bacterial endocarditis caused by susceptible bacteria, among others. (Company Announcement)

HEC Pharm’s Insulin Glargine Approved for Marketing

On the 28th, the official website of the National Medical Products Administration (NMPA) announced that HEC Pharm's Insulin Glargine Injection has been approved for marketing. Insulin glargine injection is a novel insulin analogue characterized by its long-acting profile, peakless plasma concentration, and stable blood glucose-lowering effects. (NMPA)

Dapagliflozin by Fuyuan Pharmaceutical and Lukang Pharmaceutical Simultaneously Approved for Marketing

On the 28th, the latest approval documents from the NMPA indicated that dapagliflozin from Lukang Pharma and Fuyuan Pharma were simultaneously approved for marketing. Dapagliflozin is an SGLT2 inhibitor antidiabetic drug. SGLT2 inhibitors inhibit the reabsorption of glucose in the renal tubules into the bloodstream, causing it to be excreted in the urine, thereby lowering blood glucose concentration. (NMPA)

Lianhuan Pharmaceutical's Ebastine Tablets Pass Generic Drug Consistency Evaluation

On the 29th, Lianhuan Pharmaceutical issued an announcement stating that it recently received the "Notice of Approval for Supplementary Drug Application" for Ebastine Tablets, approved and issued by the NMPA, confirming that the company's Ebastine Tablets have passed the generic drug consistency evaluation. Ebastine is a long-acting, highly selective histamine H1 receptor antagonist indicated for allergic rhinitis with or without allergic conjunctivitis. (Company Announcement)

Clinical Trial Application for Junshi Biosciences' JS026 Injection Accepted for Prevention and Treatment of COVID-19

On the 29th, Junshi Biosciences announced that it recently received the “Notice of Acceptance” approved and issued by the NMPA, confirming that the clinical trial application for JS026 Injection has been accepted. The drug is primarily intended for the prevention and treatment of novel coronavirus pneumonia (COVID-19). (Company Announcement)

TROP2-Targeting ADC Teams Up Again with Blockbuster PD-1 Inhibitor to Establish New First-Line Therapy for Triple-Negative Breast Cancer

On the 29th, Gilead Sciences announced a clinical trial collaboration with MSD to evaluate the efficacy of combining the TROP2-targeted antibody-drug conjugate Trodelvy with the blockbuster PD-1 inhibitor Keytruda as a first-line treatment for locally advanced or metastatic triple-negative breast cancer. (WuXi AppTec)

Hengrui Medicine Subsidiary's SHR-A1921 for Injection Approved for Clinical Trials

On the 29th, Hengrui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received the 《Notice of Approval for Clinical Trial of Drugs》 approved and issued by the NMPA regarding SHR-A1921 for injection, and will commence clinical trials in the near future. （Company Announcement）

Accelerating Gene Therapy Development: FDA/NIH Lead Establishment of R&D Alliance

Recently, the FDA announced a partnership among the FDA, NIH, 10 biopharmaceutical companies, and 5 non-profit organizations to jointly accelerate the development of gene therapies for the treatment of rare diseases. (WuXi AppTec)