Tianyao Pharma Fined RMB 44.02 Million for Antitrust Violation; Hengrui's PD-1 Inhibitor Camrelizumab Approved for Nasopharyngeal Carcinoma

[April 29, 2021 / Pharmaceutical News Overview]NMPA Approves and Issues the First Batch of National Standards for Traditional Chinese Medicine Formula Granules; Tianjin Pharmaceutical Shares Fined and Confiscated RMB 44.02 Million for Violating Anti-Monopoly Law; Roche’s PD-L1 Inhibitor Approved in China for Its Third Indication: First-Line Treatment of NSCLC; FDA Advisory Panel Votes 7-2 to Retain Tecentriq’s Indication for Triple-Negative Breast Cancer...Daily Fresh Pharmaceutical and Medical News: Quick Reads on What Matters to You!

Part 1 Policy Brief

NMPA Approves and Promulgates the First Batch of National Standards for Traditional Chinese Medicine Formula Granules

On the 29th, the National Medical Products Administration (NMPA) website announced that, building on previous efforts, the NMPA had organized the Chinese Pharmacopoeia Commission to carry out the development of national standards for traditional Chinese medicine (TCM) formula granules, in accordance with the "Technical Requirements for Quality Control and Standard Development of TCM Formula Granules" and relevant procedures for the establishment of national drug standards. (National Medical Products Administration)

Part 2 Industrial and Economic Observations

Tianjin Pharmaceutical Co., Ltd. Fined and Confiscated RMB 44.02 Million for Violating the Anti-Monopoly Law

On the evening of the 27th, Tianyao Pharmaceutical Co., Ltd. issued an announcement regarding its receipt of an administrative penalty decision. The announcement stated that Tianyao Pharmaceutical had divided the sales market for fluocinolone acetonide active pharmaceutical ingredients (API) through agreements, and had altered and fixed the prices of fluocinolone acetonide API, thereby excluding and restricting competition in the sales sector of this API, in violation of the Anti-Monopoly Law of the People's Republic of China. Consequently, the Tianjin Municipal Administration for Market Regulation decided to confiscate illegal gains amounting to over RMB 8.89 million from Tianyao Pharmaceutical and impose a fine of RMB 35.12 million, equivalent to 4% of its sales revenue in 2019. The total amount confiscated and fined was RMB 44.02 million. (Sina Pharmaceutical News)

Pfizer Acquires Amplyx to Expand Anti-Infective Drug Pipeline

Pfizer Announces Acquisition of Amplyx PharmaceuticalsPfizer has announced the acquisition of Amplyx Pharmaceuticals. Through this transaction, Pfizer will acquire Amplyx’s lead compound, fosmanogepix (APX001), as well as ownership of its early-stage pipeline, which includes potential antiviral (MAU868) and antifungal (APX2039) therapies. (Immediate Pharma News)

Novartis Reports Q1 2021 Net Sales of $12.411 Billion

On the 27th, Novartis announced its financial results for the first quarter of 2021, with net sales reaching $12.411 billion (+1%), basically flat compared to the same period last year. Sales in the Chinese market reached $744 million, an increase of 11%. Novartis' current business is divided into two main lines: innovative drugs and generic drugs. In the first quarter, net sales of innovative drugs were $10.1 billion (+4%), while the generics business, mainly handled by Sandoz, reported net sales of $2.3 billion (-9%). (Pharmaceutical Cube)

Amgen Announces First-Quarter 2021 Results: Strong Growth in Biosimilars

On the 27th, Amgen announced its financial results for the first quarter of 2021, with net sales of $5.9 billion (-4%), representing a slight decline compared to the same period last year, primarily due to the impact of COVID-19. Despite a 5% year-over-year decrease in product sales volume, several products still achieved double-digit growth, including Repatha (evolocumab), Prolia (denosumab), and the biosimilars MVASI (bevacizumab) and KANJINTI (trastuzumab). (Pharmaceutical Cube)

Sanofi Q1 2021: Dupilumab €1.047 billion, up 35%

Sanofi Announces Q1 Results: Net Sales Reach €8.591 Billion, Down 4.3% Year-on-Year; Dupixent Sales Surge 34.9% to €1.047 BillionSanofi announced its first-quarter results, with net sales totaling €8.591 billion, a year-on-year decrease of 4.3%. Among these, pharmaceuticals revenue amounted to €6.563 billion (-3%), vaccines revenue reached €915 million (+0.7%), and consumer healthcare revenue stood at €1.113 billion (-14.4%). Sanofi’s blockbuster drug for atopic dermatitis and asthma, Dupixent (dupilumab), saw a 34.9% growth, reaching €1.047 billion, aligning with Sanofi’s expectation of peak annual sales exceeding €10 billion. (PharmaCube)

Part 3 Pharmaceutical News

Luoxin Pharmaceutical Launches Phase III Clinical Trial in China for New Constipation Drug

Latest News from the China Drug Clinical Trial Registration and Information Publicity Platform: Luoxin Pharmaceutical Has Initiated a Phase III Trial to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation. Publicly available information indicates that plecanatide (brand name Trulance) is the first novel drug that mimics the function of endogenous uroguanylin protein. (Medical Horizon)

Innovent Ophthalmic Drug IBI302 Completes First Patient Dosing in Phase II Clinical Trial

Innovent Biologics Announces First Patient Dosed in Phase II Clinical Study of Its Global First-in-Class Ophthalmic Dual VEGF/Complement Inhibitor (Development Code: IBI302)Innovent Biologics announced that the first patient has been dosed in the Phase II clinical study of its global first-in-class ophthalmic dual-target drug against VEGF and complement (development code: IBI302). This randomized, double-blind, multicenter, active-controlled Phase II clinical study is conducted in subjects with active subfoveal or juxtafoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD). The primary objective of the study is to evaluate the efficacy and safety of IBI302, the dual-target therapy, in treating nAMD. (PR Newswire)

FDA Panel Votes 7-2 to Retain Tecentriq’s Indication for Triple-Negative Breast Cancer

Recently, the FDA held a three-day meeting on the accelerated approval of PD-1/L1 immuno-oncology drugs. On the first day, the advisory committee discussed Tecentriq (atezolizumab) from Roche, one of the largest players in this field. Atezolizumab is a PD-L1 inhibitor, and Roche has been hoping to use it to make up for market share lost in biosimilar competition. In the end, the experts voted 7:2 to retain the drug’s approval while further studies are conducted. (PharmaCube)

Improved New Drug "Budesonide Extended-Release Capsules" Receives FDA Priority Review

Calliditas Announces FDA Acceptance of New Drug Application (NDA) for Nefecon (Budesonide Delayed-Release Capsules) for the Treatment of IgA Nephropathy; Priority Review Granted with PDUFA Date Set for September 15, 2021. Nefecon is Poised to Become the First FDA-Approved Therapy for IgAN. (PharmaCube)

Novo Nordisk’s Once-Weekly New Diabetes Drug Officially Approved in China

On the 29th, Novo Nordisk announced that the National Medical Products Administration (NMPA) had approved the marketing application in China for Ozempic® (semaglutide injection), developed and manufactured by Novo Nordisk. Ozempic® (semaglutide injection) is a novel long-acting glucagon-like peptide-1 (GLP-1) analogue from Novo Nordisk, which has already been approved for marketing in 52 countries and regions, including the United States, Europe, Canada, and Japan. (Sina Pharmaceutical News)

Roche’s “Baloxavir Marboxil Tablets” Approved for Market Launch in China

According to the official website of the National Medical Products Administration (NMPA), Roche’s baloxavir marboxil tablets (brand name: Xofluza), submitted for approval in China, have been approved by the NMPA for marketing in the country. The indicated use is for the treatment of influenza in patients aged 12 years and older, including those at high risk of developing influenza-related complications. (PharmaCube)

Roche’s PD-L1 inhibitor gains approval for its third indication in China! First-line treatment for NSCLC

According to the official website of the National Medical Products Administration (NMPA), Roche’s PD-L1 inhibitor atezolizumab (Tecentriq) has received NMPA approval for a new indication (acceptance number: JXSS2000033). It is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), and whose tumors have been assessed as having ≥50% PD-L1 staining-positive tumor cells (TC ≥50%) or PD-L1-positive immune cells (IC) covering ≥10% of the tumor area (IC ≥10%). This marks the third indication approved for atezolizumab in China. (PharmCube)

China Approves First Global New Indication for CD38 Monoclonal Antibody

Recently, the official website of the National Medical Products Administration (NMPA) announced that the new indication application for daratumumab injection (Darzalex) submitted by Xian Janssen in China (Acceptance No.: JXSS2000019/20) has been approved by the NMPA. The approved indication is for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone. This marks the second indication approved for this product in China. (PharmaCube)

Hengrui’s PD-1 Inhibitor Approved for Nasopharyngeal Carcinoma Indication

According to the official website of the National Medical Products Administration (NMPA), the marketing application for the new indication of Hengrui's camrelizumab for injection (registration category: 2.2; acceptance number: CXSS2000045) has been approved by the NMPA. (National Medical Products Administration)

Ascletis Posaconazole Injection Passes Consistency Evaluation

According to data from the NMPA website, AskPharma’s application for market approval of its Class 3 generic posaconazole injection has entered the “under review” status, positioning it to potentially become the first generic version and the first product to pass consistency evaluation in China. Posaconazole is a second-generation triazole antifungal agent. Merck & Co.’s posaconazole achieved global sales of USD 662 million in 2019. In January this year, the first domestically produced generic posaconazole enteric-coated tablets were approved; however, no generic injectable formulations have yet received market approval. (Menet)