Suzhou-based CStone Pharmaceuticals Submits New Indication Application for PD-L1 Inhibitor Sugemalimab; FDA Mandates Black Box Warning for JAK Inhibitors

【September 2, 2021 / Pharmaceutical News Overview】Innovent Biologics and GenFleet Therapeutics Reach $312 Million Collaboration Agreement on KRAS Inhibitor; Pfizer, Eli Lilly, and AbbVie JAK Inhibitors Receive FDA Warning Over Cardiovascular Safety and Cancer Risks; CStone Pharmaceuticals Submits Marketing Authorization Application for Anti-PD-L1 Monoclonal Antibody in New Indication……Daily Latest Pharma & Medical News: Quick Digests for Your Attention!

Part 1 Policy Brief

NMPA Revises Package Insert for Creatine Phosphate Sodium for Injection

On the 1st, based on the evaluation results of adverse drug reactions, and to further ensure public medication safety, the NMPA has decided to uniformly revise and update the package insert for Creatine Phosphate Sodium for Injection. (NMPA)

NMPA: Huachen Medical Equipment Circumcision Stapler Is Being Recalled

On the 1st, the NMPA issued an announcement regarding the voluntary recall by Huachen Medical Equipment of certain non-compliant products, including circumcision staplers. (NMPA)

Implementation Rules for the Designated Management of Retail Pharmacies for Healthcare Security in Hunan Province Take Effect

Recently, the Hunan Provincial Healthcare Security Administration issued the 《Detailed Rules for the Management of Designated Retail Pharmacies for Medical Security in Hunan Province (Trial)》, which will officially take effect on September 1. According to the Rules, to meet the application criteria for designated medical security status, a retail pharmacy must have been in official operation at its registered address for at least three months and must employ at least one pharmacist holding a Licensed Pharmacist Qualification Certificate or a Professional Technical Qualification Certificate in Pharmacy, Clinical Pharmacy, or Traditional Chinese Pharmacy. (Hunan Provincial Healthcare Security Administration)

Part 2: Industry & Economics Review

Innovent Biologics and Genfleet Therapeutics Enter into $312 Million Collaboration Agreement for KRAS Inhibitor

On the 2nd, Innovent Biologics announced a licensing agreement with Genfleet Therapeutics, granting Innovent exclusive rights to develop and commercialize the latter’s KRAS G12C inhibitor GFH925 in China, along with an option for global development and commercialization rights. Innovent will pay Genfleet a $22 million upfront payment and cumulative global development support payments of up to $50 million. If Innovent exercises the option for global rights, Genfleet will receive milestone payments totaling up to $240 million for global development, regulatory approval, and sales, as well as tiered royalties based on the annual sales of GFH925 in both the Chinese and global markets. (Corporate Announcement)

Weikang Pharmaceutical Acquires 70% Stake in Oujiang Capsule

On the 2nd, Weikang Pharmaceutical announced that it signed the 《Equity Transfer Agreement》 with shareholders Wang Shiguo and Wang Linsu on August 26, 2021. Utilizing its own funds of RMB 36.75 million, the company acquired the 54.0741% equity interest in Oujiang Capsule held by Wang Shiguo and the 15.9259% equity interest held by Wang Linsu, resulting in a total acquisition of 70% equity in Oujiang Capsule. （Corporate Announcement）

HebeCell Closes $53 Million Series A Financing

On the 1st, HebeCell announced the completion of a $53 million Series A financing round. The proceeds will be used to advance the R&D of its proprietary "off-the-shelf" pluripotent stem cell-derived CAR-NK cell therapy, submit IND applications, and promote clinical application and commercialization. (WuXi AppTec)

PegBio's STAR Market IPO Application Accepted; Plans to Raise RMB 2.538 Billion

On August 31, according to a disclosure by the Shanghai Stock Exchange, the Listing Committee has accepted the listing application of PegBio. PegBio plans to raise RMB 2.538 billion through this IPO, with the proceeds to be used for the R&D of innovative drugs and the construction of its production base and R&D center. (Company Announcement)

Simcere and AlphaMa Enter into Collaboration on Novel Anti-Tumor Drug ALM005

On August 30, Simcere and AlphaMa jointly announced that they have signed an exclusive licensing agreement for the novel anti-tumor drug ALM005, under which Simcere will obtain the global development and commercialization rights for ALM005 across all indications. (PharmaCube)

Fovo Pharmaceutical Completes Nearly RMB 100 Million Series A Financing

On the 2nd, Forward Pharma announced that the company recently completed a Series A financing round of nearly RMB 100 million, led by the CSPC Xiantong New Drug Fund, with existing shareholders and affiliated parties participating in the follow-on investment. The funds from this round will be primarily used for: the China-U.S. Phase I clinical trial of FWD1509, the company's fourth-generation targeted therapy for non-small cell lung cancer (NSCLC), which has already been initiated, among other purposes. (Company Announcement)

Dr. Liu Mengyuan Joins Curegene as Group President

On the 2nd, Kerui Gene announced that Dr. Liu Mengyuan has officially joined the company as a co-founder and board member, serving as Group President. (PR Newswire)

Part 3: Pharmaceutical & Medical News

Pfizer, Eli Lilly, and AbbVie JAK Inhibitors Face FDA Warning Over Cardiac Safety and Carcinogenic Risks

On the 1st, the FDA required Pfizer's Xeljanz, AbbVie's Rinvoq, and Eli Lilly's Olumiant to include clear labeling warning that patients receiving treatment face cardiovascular and cancer risks. All three drugs belong to the JAK inhibitor class. (Sina Medical News)

Takeda's First-in-Class NAE Inhibitor Pevonedistat Fails in Phase III Clinical Trial

On the 2nd, Takeda announced that the Phase 3 PANTHER study (Pevonedistat-3001, NCT03268954) did not meet the prespecified statistical significance for its primary endpoint of event-free survival (EFS). The trial was conducted in patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia with low blast counts, evaluating whether first-line treatment with pevonedistat in combination with azacitidine could improve EFS compared with azacitidine monotherapy. (Sina Medical News)

Astellas Halts Clinical Trial for Gene Therapy AT132

Recently, Astellas announced that it has suspended the clinical trial of gene therapy AT132 for patients with X-linked myotubular myopathy following a serious adverse event in one trial participant. (Sina Medical News)

Foreign Particles in Japanese Moderna Vaccines Identified as Stainless Steel Fragments

On the 2nd, Kyodo News reported that regarding the issue of foreign matter found in vials of the US-made Moderna COVID-19 vaccine and the subsequent suspension of its use, Japan's Ministry of Health, Labour and Welfare announced that, following an investigation by Takeda Pharmaceutical Company Limited, the foreign matter was identified as stainless steel, reportedly fragments from production equipment. (Kyodo News)

Positive Results from Phase II Trial of Topical Glucocorticoid Therapy

On August 31, AxeroVision announced that AXR-270, an innovative once-daily glucocorticoid cream, achieved positive results in a Phase 2 clinical trial for patients with dry eye disease associated with meibomian gland dysfunction. Preclinical studies demonstrated that, compared with topical eye drop administration, AXR-270 cream provides prolonged drug exposure, supporting a once-daily dosing regimen. (WuXi AppTec)

BeiGene's Brukinsa Receives FDA Approval for the Treatment of Adult Waldenström's Macroglobulinemia

On the 2nd, BeiGene announced that Brukinsa received FDA approval for the treatment of adult patients with Waldenström's macroglobulinemia. (Sina Medical News)

Zai Lab’s Qinlock® Approved in Taiwan for the Treatment of Advanced Gastrointestinal Stromal Tumors

On the 2nd, Zai Lab announced that Taiwan's drug regulatory authority has approved the New Drug Application for Qinlock® for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received three or more prior kinase inhibitor therapies, including imatinib. (PR Newswire)

Junshi Biosciences' toripalimab has completed the rolling submission of its Biologics License Application (BLA) to the FDA.

On the 2nd, Junshi Biosciences announced that its subsidiary, TopAlliance Biosciences, has completed the rolling submission to the U.S. FDA of a Biologics License Application (BLA) for toripalimab in combination with gemcitabine/cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and as a monotherapy for second-line or later treatment of recurrent or metastatic nasopharyngeal carcinoma following platinum-based therapy. (Company Announcement)

CStone Pharmaceuticals Submits NDA for New Indication of Anti-PD-L1 Monoclonal Antibody

On the 2nd, Cstone Pharmaceuticals announced that the NMPA has accepted the New Drug Application (NDA) for sugemalimab, an anti-PD-L1 monoclonal antibody, as consolidation therapy for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential chemoradiotherapy. This marks the eighth NDA or supplemental application for expanded indications submitted by Cstone Pharmaceuticals. (Yiyao Guanlan)

Joincare’s Tobramycin Inhalation Solution Marketing Authorization Application Accepted by CDE

On the 1st, Joincare’s marketing application for Tobramycin Inhalation Solution, submitted as a Class 2.4 new drug, was officially accepted by the CDE. Tobramycin is an aminoglycoside antibiotic that exerts its antibacterial effect by binding to the bacterial 30S ribosomal subunit and inhibiting bacterial protein synthesis. It is indicated for infections caused by Staphylococcus and Gram-negative bacilli. (CDE)

Ascletis FXR Agonist Completes China Bridging Trial for Hepatitis B Indication, Initiates Phase II Clinical Trial

On the 25th, Ascletis Pharma announced that ASC42, a farnesoid X receptor (FXR) agonist, has completed the China bridging study for the chronic hepatitis B indication and initiated a Phase II clinical trial. (PR Newswire)

# FDA Approves Twice-Yearly Schizophrenia Treatment

On the 1st, Janssen, a Johnson & Johnson company, announced that the FDA has approved its long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate for once-every-six-months administration) for marketing, for the treatment of schizophrenia in adults. (Company announcement)

Jincheng Pharma Subsidiary Receives Acceptance Notice for Consistency Evaluation of Cefazolin Sodium for Injection

On the 2nd, Jincheng Pharmaceutical announced that on September 1, 2021, the company received a notice from its holding subsidiary, Jincheng Jinsu, stating that Jincheng Jinsu had received an Acceptance Notice from the NMPA for the Consistency Evaluation of Cefazolin Sodium for Injection. (Corporate Announcement)

Xinhua Medical Subsidiary Receives Class II Medical Device Registration Certificate for Arthroscopic Surgical Instruments

On the 2nd, Xinhua Medical announced that its controlled subsidiary, Xinhua Surgical Instrument, recently obtained the "Medical Device Registration Certificate of the People's Republic of China" issued by the Shandong Provincial Medical Products Administration. The product is intended for use in conjunction with an arthroscope for examination during arthroscopic surgery or for intraoperative manipulation. (Company Announcement)

Yiling Pharmaceutical's Wholly-Owned Sub-Subsidiary's Letrozole Tablets Obtain Drug Registration Certificate

On the 2nd, Yiling Pharmaceutical announced that the Company has received a notice from the NMPA. The marketing authorization application for Letrozole Tablets, submitted to the CDE by Beijing Yiling Biotechnology Co., Ltd. (a wholly-owned subsidiary of Yiling Wanzhou International Pharmaceutical Co., Ltd., which is a wholly-owned subsidiary of the Company), has been approved by the NMPA, and the Drug Registration Certificate has been obtained. (Company Announcement)

Cisen Pharmaceutical Receives Drug Registration Approvals for Aspirin Enteric-Coated Tablets and Metformin Hydrochloride Extended-Release Tablets

On the 2nd, Cisen Pharmaceutical announced that the company has received the 《Notice of Approval for Supplementary Drug Application》 for Aspirin Enteric-coated Tablets and the 《Drug Registration Certificate》 for Metformin Hydrochloride Extended-Release Tablets, both approved and issued by the NMPA. The indications for Aspirin Enteric-coated Tablets are as follows: reducing the risk of onset in patients with suspected acute myocardial infarction, preventing recurrence of myocardial infarction, secondary prevention of stroke, and reducing the risk of transient ischemic attack (TIA) and subsequent stroke, etc. (Company Announcement)

Abogen/Walvax mRNA Vaccine Approved for Overseas Phase III Clinical Trial

On the 1st, Walvax Biotechnology issued an announcement stating that the Phase III clinical trial of the novel coronavirus mRNA vaccine ARCoVax, co-developed with Abogen Biosciences, has recently received approval from the regulatory authorities in Mexico and Indonesia, respectively. (Company Announcement)

Harbour BioMed’s Batoclimab Approved for Phase II Clinical Trial in CIDP

Recently, Harbour BioMed announced that the Center for Drug Evaluation (CDE) has approved its investigational product, batoclimab, for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to directly enter Phase II clinical trials. (CDE)

Merck's Molnupiravir Enters Phase 3 Clinical Trial for COVID-19 Post-Exposure Prophylaxis

Recently, Merck and Ridgeback Biotherapeutics jointly announced the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir for post-exposure prophylaxis of COVID-19 infection. This global study will enroll individuals aged ≥18 years who reside in the same household as a person with a laboratory-confirmed, symptomatic SARS-CoV-2 infection. (Bioon)

Chia Tai Tianqing to Secure First Generic of Blockbuster Drug

Recently, the Class 4 generic application for everolimus tablets submitted by Chia Tai Tianqing Pharmaceutical has entered the administrative approval stage. Currently, no generic version of this product has been approved in China. Everolimus is an mTOR inhibitor developed by Novartis, featuring triple anti-tumor effects: inhibiting tumor cell growth and proliferation, suppressing tumor nutrient metabolism, and exerting anti-angiogenic activity. (NMPA)