In the first three days of this week, the XBI index of U.S. biotech stocks rose consecutively, breaking through the 100 USD/share mark, kicking off a good start for the pharmaceutical industry this week.Multinational pharmaceutical companies Johnson & Johnson and Novartis were the first to release their Q2 financial reports. The former's collaboration with Legend Biotech on Cilta-cel achieved sales of $343 million in the first half of the year, representing an 81.5% year-on-year increase; the latter's net sales in China reached $1.1 billion in the second quarter, marking a 27% year-on-year growth. Additionally, Eli Lilly's tirzepatide weight loss indication was approved in China this week, further strengthening the GLP-1 market.In terms of large domestic pharmaceutical enterprises, CR PHARMA COMM has once again made a significant expansion move. Its subsidiary, Boya Bio-pharmaceutical, plans to acquire 100% of the equity of Green Cross Hong Kong for 1.82 billion yuan in self-owned funds to expand its plasma collection layout.In the biotech field, the first major radiopharmaceutical License-out collaboration has emerged, with Fulllink Technology licensing a radiopharmaceutical product to South Korea's SK Biopharmaceuticals for over 4 billion yuan.In terms of policy,Following the release of Chongqing's anti-commercial bribery compliance guidelines in the pharmaceutical sector last week, Hebei Province also issued its anti-commercial bribery compliance guidelines this week.Pointing the Way for Pharmaceutical Companies' Compliance.China's National Medical Security Standardization Working Group Established:On July 18, the establishment conference of the National Healthcare Security Standardization Working Group was held at the National Healthcare Security Administration. The working group will coordinate the formulation of various healthcare security standards and promote the high-quality development of healthcare security. The group will establish a standardization mechanism led by the National Healthcare Security Administration and cooperatively advanced by regions across China, forming a standardization system that adapts to the reform and development of healthcare security. It will also gradually create a national healthcare security standards checklist. Meanwhile, it will improve the framework of standards, strengthen foundational research on standards, manage the formulation, revision, and review of national standards, and enhance standardization work in key areas.Hebei Releases Provincial Anti-Commercial Bribery Compliance Guidelines:Following the release of Chongqing's anti-commercial bribery compliance guidelines in the pharmaceutical sector last week, Hebei Province also issued its own anti-commercial bribery compliance guidelines this week. The involved fields include operational entities engaged in the production, research and development, sales, and related goods and associated businesses of medical products such as pharmaceuticals and medical devices. These include, but are not limited to, Marketing Authorization Holders (MAH) for pharmaceuticals/medical devices, Contract Research Organizations (CRO) for pharmaceuticals/medical devices, Contract Manufacturing Organizations (including CMO and CDMO) for pharmaceuticals/medical devices, Contract Sales Organizations (CSO) for pharmaceuticals/medical devices, and commercial distribution enterprises for pharmaceuticals/medical devices, indicating an even broader coverage.Hunan Issues Price Correction Notice for Online Listed Drugs:On July 17, the Hunan Provincial Public Resources Trading Center issued the "Notice on Price Correction for Listed Drugs (First Batch of 2024)," disclosing 234 drugs that clearly do not meet the price management requirements of Hunan Province. According to the notice, the scope of this price correction includes generic drugs with a minimum formulation unit price higher than the lowest listed price of the reference preparation with the same generic name, dosage form, and specification; non-generic drugs with a minimum formulation unit price higher than the lowest listed price of generic drugs with the same generic name, dosage form, and specification; and drugs with comparable prices per minimum formulation unit higher than other specifications from the same manufacturer or different packaging quantities of the same specification.The original winning company of cefodizime sodium in the eighth batch of national procurement has been suspended from import:On July 18, the Joint Procurement Office of the National Organization for Medicines announced that DAEWOONG BIO INC. failed to accept the overseas on-site dynamic inspection by the National Medical Products Administration (NMPA) for the selected product, Cefodizime Sodium for Injection, as required. This action violates the "Drug Administration Law of the People's Republic of China" and the "Regulations on the Management of Overseas Inspections of Drugs and Medical Devices." The NMPA determined the inspection result as "non-compliant." On July 18, 2024, the National Medical Products Administration issued an announcement suspending the importation, sale, and use of this product. The company breached the commitments made in its application materials and violated relevant clauses of the "National Centralized Drug Procurement Document (GY-YD2023-1)." The Joint Procurement Office decided to revoke DAEWOONG BIO INC.'s qualification as the selected supplier of Cefodizime Sodium for Injection. Additionally, the company has been placed on the "Violation List," and its eligibility to participate in the national centralized drug procurement activities has been suspended from July 18, 2024, to January 17, 2026.Eli Lilly's Tirzepatide Weight Loss Indication Approved in China:On July 19, Eli Lilly's Mounjaro (tirzepatide injection) received approval from the National Medical Products Administration (NMPA) for long-term weight management. It is indicated for adults with a body mass index (BMI) meeting the following criteria, in addition to diet control and increased physical activity: ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) with at least one weight-related comorbidity. Mounjaro is the first and currently the only approved glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist, as well as the first innovative drug in Eli Lilly’s obesity treatment portfolio to be approved in China.Novartis Q2 Earnings Exceed Expectations:On July 18, Novartis released its Q2 financial report, showing global net sales of $12.5 billion, a year-on-year increase of 11%. Net sales in China for the second quarter reached $1.1 billion, a year-on-year increase of 27%. Among these, Entresto's global sales in Q2 were $1.898 billion, growing by 28% year-on-year, while Cosentyx's global sales were $1.526 billion, marking a year-on-year increase of 22%.Johnson & Johnson's Revenue in the First Half of the Year: $43.83 BillionOn July 17, Johnson & Johnson was the first to release its financial report, with global H1 revenue of $43.83 billion, a year-on-year increase of 3.3%. Of this, pharmaceutical business revenue was $28.052 billion. The H1 sales of Cilta-cel, co-developed by Johnson & Johnson and Legend Biotech, reached $343 million, marking an 81.5% year-on-year increase.Gilead Chief Science Officer to Step Down:On July 17, Gilead announced that its current Chief Medical Officer, Merdad Parsey, will leave the company in early 2025. During this period, Merdad Parsey will continue to serve until the end of Q1 2025.Bayer's First Personnel Appointment After Organizational Restructuring:On July 16, Zhou Xiaolan, Global Executive Vice President of Bayer Group's Pharmaceuticals Division and President of Bayer Group Greater China, announced the first personnel appointment under the new operating model to employees. Yang Hao, the current General Manager of Bayer Pharmaceuticals South China, will assume the role of General Manager of Core Product Business under the new structure, effective August 1. The workplace will be in Shanghai, reporting directly to Zhou Xiaolan, President of Bayer Group Greater China.Hengrui Receives FDA Warning Letter:Recently, Hengrui Medicine received a warning letter from the U.S. Food and Drug Administration (FDA) regarding compliance with Good Manufacturing Practice (GMP) for pharmaceuticals. The FDA identified issues in eight areas at a factory located on Huanghe Road in Lianyungang, Jiangsu, including operational procedures, record management, and sanitation. Hengrui Medicine responded by stating that the company will actively engage internal and external experts as well as third-party consulting firms to implement relevant recommendations and maintain close communication with the FDA.Grand Pharmaceutical Completes Acquisition of 100% Equity in Tianjin Tanabe and Beigene:On July 17, Grand Pharmaceutical announced the completion of the registration for the 100% equity change of Tianjin Tanabe Seiyaku Co., Ltd., Nanchang BeiGene Pharmaceutical Co., Ltd., and Jiangxi Bai'an Billion Pharmaceutical Technology Co., Ltd. These two acquisitions will further deepen its industrial layout in the cardiovascular emergency care and respiratory and critical care sectors.Dongyang Light Medicine Sitagliptin Patent Infringement Dispute Case Wins:Recently, the final verdict was handed down in two cases of patent infringement disputes filed by MSD China against Guangdong East Sunshine Pharmaceutical Co., Ltd. The Supreme People's Court issued civil judgments (2022) ZGFG ZMZE No. 1062 and No. 1194, dismissing MSD China's appeal and upholding the first-instance court's decision to reject all of MSD China's claims. East Sunshine Pharma once again emerged victorious.Hengrui Gene Therapy Submits IND Application:On July 17, the clinical trial application for RGL-193 Injection from Ruihongdi Medicine, a subsidiary of Hengrui Medicine, was accepted by the NMPA. According to public information from Ruihongdi Medicine, RGL-193 is a dual-gene AAV therapeutic drug that is injected into patients' brains using stereotactic technology. It enhances the conversion efficiency of levodopa, reduces the dosage and dose-related adverse reactions, while repairing damaged dopaminergic neurons.First Nuclear Medicine License-out Collaboration Born:On July 17, Fluorine Link Technology Co., Ltd. announced that it had signed an out-licensing agreement with SK Biopharmaceuticals. Under the agreement, Fluorine Link grants SK exclusive global rights to conduct clinical research, development, manufacturing, and commercialization of the radiopharmaceutical FL-091 for cancers positive for neurotensin receptor 1 (NTSR1), with a total transaction value of $571.5 million (over 4 billion yuan).Tasly Biologics' Synthetic Chemical API "Ursodeoxycholic Acid" Approved for Marketing:Recently, Chuan Ning Bio announced that it had received the "Approval Notice for Chemical Raw Material Drug Marketing Application" issued by the National Medical Products Administration for the company's raw material drug ursodeoxycholic acid. The preparation of ursodeoxycholic acid is ursodeoxycholic acid tablets (capsules), a choleretic drug. Indications: For patients with normal gallbladder contractile function, used in the non-surgical treatment of X-ray penetrable cholesterol gallstones; cholestatic liver disease (e.g., primary biliary cirrhosis); bile reflux gastritis; steatorrhea (post-ileal resection).BeiGene Appoints New Chief Financial Officer:BeiGene announced on July 18 that Aijun (Julia) Wang, a senior executive of the company, has recently submitted a resignation application to seek external development opportunities. She will officially step down as the Chief Financial Officer of the company on July 19, 2024. The company's board of directors has agreed to appoint Aaron Rosenberg as the Chief Financial Officer of the company and designate Rosenberg as a senior executive, effective from July 22, 2024.Vertex Collaborates with Orum to Develop 3 DACs:On July 16, Orum Therapeutics announced a global, multi-target research and development and licensing agreement with Vertex to develop up to three antibody conjugated protein degrader (DAC) drugs. Under the agreement, Orum will receive a $15 million upfront payment and is eligible for up to $310 million in option fees and milestone payments per drug.Harbour BioMed Announces Positive Profit Forecast for the First Half of 2024:On July 19, Harbour BioMed expected a profit of approximately US$1 million to US$1.5 million for the first half of the year, compared with a profit of approximately US$2.9 million in the same period last year. The main reason for the expected decrease in profit during the reporting period is the change in revenue structure. Specifically, compared with the first half of 2023, the proportion of service business revenue in total revenue increased during the reporting period. However, the profit margin of this type of business revenue is relatively lower compared with the higher proportion of licensing business revenue during the same period. Therefore, the overall profit during the reporting period decreased.CEO of CBC Group, Fu Wei, Appointed as Chairman of the Board of I-Mab:On July 15, I-Mab announced that the company's board of directors had appointed Mr. Wei Fu as chairman of the board. It is reported that Wei Fu has been a member of the company’s board of directors since June 2018. He is the Chief Executive Officer of CBC Group (Kangqiao Capital), a healthcare asset management company, and also the founding shareholder and largest shareholder of I-Mab.Pylon Bio Grants 50% Rights to CDK7 Inhibitor Cancer Drug:On July 19,湃隆生物 announced that it had reached an agreement with Exscientia to sell 50% of its rights in the highly selective oral CDK7 inhibitor GTAEXS617 to Exscientia. According to the agreement,湃隆生物 will receive a transaction consideration worth $30 million, including $10 million in cash, $10 million in Exscientia stock, and high single-digit royalties from the project's external licensing, with a potential value exceeding $100 million. Additionally, Exscientia will assume all ongoing research and development costs for GTAEXS617.NK Cell Therapy Biotech Makes Another IPO Push:On July 15, Artiva Biotherapeutics updated its IPO plan, announcing that it would sell 8.7 million shares at a price of $14-$16 per share, with an expected net proceeds of $116.8 million. Additionally, if the underwriters exercise their 30-day option to purchase 1.3 million shares at $15 per share, the net proceeds will increase to $135 million.AusperBio Completes $37 Million Series A Financing:On July 15, AusperBio announced the completion of a $37 million Series A financing round. This round was led by InnoPinnacle Fund with additional participation from Vivo Capital, H&Q China, Qiming Venture Partners, and OrbiMed. The proceeds will primarily be used to advance the Phase II clinical trial of AusperBio's potential cornerstone hepatitis B cure, AHB-137, explore combination therapy regimens, and support a series of development activities including CMC production. Additionally, the funds will also be utilized to expand the proprietary Med-Oligo™ technology platform and its product pipeline.Suzhou High-Tech Subsidiary Plans to Invest in Establishing a Biopharmaceutical Fund：On July 18, Suzhou High-Tech announced that its subsidiary, Suzhou High-Tech Investment Management Co., Ltd., and Suzhou Medical Device Industry Development Group Co., Ltd., plan to jointly participate as limited partners with the controlling shareholder, SND Group, in establishing the Jiangsu Biomedical (Suzhou) Industry Special Fund. Among them, the investment management company will contribute no more than 584 million yuan, the medical device industry company will contribute no more than 117 million yuan, and SND Group will contribute no more than 584 million yuan. This transaction constitutes a related-party transaction, which still needs to be submitted to the shareholders' meeting for review and requires approval from the state-owned assets supervision and administration department.CR PHARMA COMM Plans to Acquire 100% Equity of Green Cross Hong Kong:On July 17, CR PHARMA COMM, China Resources Boya Bio-pharmaceutical, and GC Group held a signing ceremony for the strategic cooperation agreement and equity transfer agreement in Shanghai. China Resources Boya Bio-pharmaceutical plans to acquire 100% of the equity in Green Cross (Hong Kong) Holdings Limited, held by GC Group, for RMB 1.82 billion in self-owned funds, thereby indirectly acquiring its blood products main body in China, Green Cross (China) Biological Products Co., Ltd.First Trial | Huang Jia
Second Review | Li Fangchen
Third Review | Li Jingzhi
