Haier Biotech Plans Share-Swap Acquisition of Shanghai RAAS; Innovent and Hansoh Forge MNC Partnerships; Another Domestic Innovative Drug Approved in the U.S.

This week, centralized procurement and cooperation remain the two major topics in the pharmaceutical industry. Following the release of the tentative winning results of the tenth batch of drug centralized procurement last week, the fifth batch of cochlear implants and peripheral vascular stents centralized procurement successfully opened for bidding this week. Unlike drug procurement, multiple foreign enterprises won bids in this round of medical device procurement.

In terms of new drug collaborations, Innovent Bio first reached a commercialization partnership with Eli Lilly for a BTK inhibitor, followed by Hansoh Pharma granting the global rights of a GLP-1 new drug to Merck. License-in has also become an important pathway for local pharmaceutical companies to bolster their pipelines, as Fosun Henlius introduced a glyco-editing therapy this week for nearly 100 million USD.

In addition, the approval of重磅 new drugs has also sparked heated discussions this week. Betta Pharmaceuticals' first domestically produced ALK inhibitor, Ensartinib, was approved by the FDA for marketing, adding a strong player to the list of Chinese drugs going overseas; Eli Lilly's significant new Alzheimer's drug was also approved for marketing in China this week.

What other major events happened this week?

The Fifth Batch of Artificial Cochlear and Peripheral Vascular Stent Centralized Procurement Successfully Opened for Bidding:On December 19, the fifth centralized bulk procurement of high-value medical consumables organized by the Chinese government was officially launched in Tianjin. The demand for cochlear implant-related consumables in this procurement amounted to 11,000 sets, with five companies winning bids and prices dropping from an average of over 200,000 yuan to around 50,000 yuan. The demand for peripheral vascular stent-related consumables reached 258,000 units, with 18 companies selected, and prices falling to two or three thousand yuan.

China's National Healthcare Security Administration Requests Investigation into Issues Such as Fictitious Invoices and "Dual Pricing" for Medicines:On December 20, the National Healthcare Security Administration issued a letter regarding attention to the issue of certain pharmaceutical companies issuing fake invoices to create "two-tier pricing." The letter requests a thorough investigation into whether products such as Ginkgo Biloba Extract Injection, Cefazolin Sodium Injection, and Hydrolyzed Protein Oral Solution have similar issues, urging a quick assessment of the actual listed prices. In some regions, it has been exposed that certain drugs have two price systems: the "base price" and the "invoice price." Pharmaceutical companies first sell the drugs to distributors at the "invoice price," who then sell them to medical institutions. After the transaction is completed, the pharmaceutical company returns the difference between the "invoice price" and the "base price" to the distributor. The significant price difference is "laundered" and "cashed out" through fake invoicing, causing some drug prices to be artificially inflated from the outset. In the letter, the National Healthcare Security Administration firmly opposed inflated drug prices that burden patients, firmly opposed fake invoicing that forms illegal profit chains, and firmly opposed violations such as "dual pricing" and "bribery sales."

Public Notice of Hunan's National Negotiation Dual-Channel Single-Payment Directory:On December 20, the Hunan Provincial Medical Security Bureau issued the "Public Notice on the 2025 Hunan Province 'Dual-Channel' Single-Payment Managed Drug List," with a public comment period from December 20, 2024, to December 27, 2024. The dual-channel single-payment drug list under public notice includes 268 varieties: 263 Western medicines and 5 traditional Chinese medicines, of which 56 are newly added (including 2 new traditional Chinese medicines). These include varieties newly negotiated into the medical insurance directory for the first time in 2024, as well as those included in previous years.

Guangdong Leads 16 Provinces in Announcing Traditional Chinese Medicine Centralized Procurement:On December 20, the Guangdong Provincial Drug Exchange Center issued a notice titled "Centralized Bulk Procurement Document for Traditional Chinese Medicine including Jinlian Flower Capsules in the Guangdong Alliance." The procurement participants are from the alliance regions, including all public medical institutions in Guangdong, Liaoning, Jilin, Heilongjiang, Anhui, Jiangxi, and other provinces. Social healthcare institutions and designated pharmacies covered by medical insurance can voluntarily participate. The procurement cycle will, in principle, last until December 31, 2026, with the possibility of a 12-month extension.

Hebei Officially Announces the Continuation of Procurement for 43 National Centralized Procurement Varieties:On December 18, the Hebei Provincial Medical Products and Devices Centralized Procurement Center issued the "Notice on Publishing the Centralized Procurement Documents for the Renewal of Expired National and Alliance (Provincial) Centralized Procurement of Drugs in Hebei Province," planning to carry out centralized procurement for 43 types of drugs from the expired national procurement and 66 types of drugs from the expired alliance (provincial) procurement. The notice states that drugs already listed on the Hebei Province Pharmaceutical and Medical Consumables Bidding and Procurement Management System and meeting the criteria must participate in the bidding; otherwise, their listing qualifications will be revoked. Drugs meeting the application criteria but not yet listed on the Hebei Province Pharmaceutical and Medical Consumables Bidding and Procurement Management System can also participate in the bidding.

SINOVAC Biotech and Kelun Pharmaceuticals Reach Strategic Cooperation for Drug Export:On December 19, Kexing Bio and Sichuan Kelun Pharmaceutical Co., Ltd. signed a cooperation agreement. Both parties reached an overseas strategic cooperation on Kelun Pharmaceutical's high-end generic drugs and innovative drugs. According to the cooperation agreement, Kelun Pharmaceutical provides a list of approved and under-research products available for cooperation, covering multiple therapeutic areas. Kexing Bio will screen the products that can be cooperated and then sign separate project cooperation agreements for specific products. Both parties will leverage their respective advantages in R&D, production, and commercialization to jointly promote the registration, listing, and sales of these products in the global market.

Merck Terminates Development of Anti-TIGIT Antibody and Anti-LAG-3 Antibody:On December 16, Merck announced the termination of the development of the anti-TIGIT antibody Vibostolimab and the anti-LAG-3 antibody Favezelimab. The main reason is that both Phase III clinical trials of Vibostolimab have failed.

Novo Nordisk's GLP-1 New Drug Fails to Meet Clinical Expectations, Stock Plummets 21%:On December 20, Novo Nordisk announced the primary results of the global Phase III clinical trial REDEFINE 1 for the GLP-1 new drug CagriSema. People who received CagriSema treatment lost 22.7% of their body weight after 68 weeks, which was less than the 25% weight loss effect previously predicted by Novo Nordisk. On the same day, Novo Nordisk's stock price plummeted 21% before the market opened.

Lilly's GLP-1 Approved for Obstructive Sleep Apnea Indication:On December 20, Eli Lilly announced that the FDA had approved its GLP-1R/GIPR dual agonist tirzepatide (Zepbound) as the first and only treatment for adults with moderate to severe obstructive sleep apnea (OSA) combined with obesity.

BMS Terminates Licensing Collaboration with ABL Bio Regarding RayzeBio Pipeline:On December 19, Bristol-Myers Squibb announced that it had reached an agreement with ABL Bio, under which Bristol-Myers Squibb regained exclusive rights to develop and commercialize ABZ-706 in Greater China (including the markets of mainland China, Hong Kong, Macao, and Taiwan). This pipeline product targets GPC3 for the treatment of hepatocellular carcinoma. The agreement also terminated a previous broad licensing deal with ABL Bio, which had granted ABL Bio the rights to develop and commercialize up to four pipeline products from RayzeBio, including ABZ-706, in these markets.

Lilly's Heavyweight Alzheimer's Drug Approved for Marketing in China:On December 18, Eli Lilly announced that the new drug donanemab injection has been approved by the China National Medical Products Administration for marketing, intended for the treatment of early Alzheimer's disease. The treatment should begin when patients are in the mild cognitive impairment stage or mild dementia stage of the disease. Donanemab is a medication administered via intravenous infusion, injected once every four weeks. This product was first approved by the U.S. FDA in July 2024 for the treatment of adult patients with Alzheimer’s disease who exhibit early symptoms.

Hansoh Pharma Grants Global Rights of GLP-1 New Drug to Merck:On December 18, Hansoh Pharma announced that it had entered into a global exclusive license agreement with Merck for the development, manufacturing, and commercialization of HS-10535, a preclinical oral small molecule GLP-1 receptor agonist. The licensor will receive an upfront payment of $112 million and is eligible to receive up to $1.9 billion in milestone payments based on the product’s development, regulatory approval, and commercialization progress, as well as royalties based on product sales.

Astellas Collaborates on Gene Therapy for Neurological Disorders:On December 19, Astellas announced a collaboration with Sangamo Therapeutics. Astellas will utilize Sangamo's innovative proprietary neurotrophic adeno-associated virus (AAV) capsid, STAC-BBB, which has demonstrated strong blood-brain barrier crossing ability and neuronal cell transduction efficacy in non-human primates. The agreement grants Astellas global exclusive rights to one target, while also allowing it to expand the rights to up to four additional targets by paying additional licensing fees, for the treatment of certain neurological disorders via intravenous gene therapy.

Novartis Brolucizumab Submission for Indication Approval in China:On December 21, the CDE website announced that Novartis' new indication application for the marketing of Brolucizumab Injection has been accepted, with the specific indication yet to be disclosed. Public data shows that Brolucizumab is a next-generation treatment for fundus diseases targeting VEGF inhibition.

BMS Introduces Innovative Drug for Alzheimer's Disease:On December 19, BioArctic announced that it had entered into a global exclusive license agreement with Bristol Myers Squibb for the Pyroglutamate Modified Amyloid Beta (PyroGlu-Aβ) antibody program, including antibodies BAN1503 and BAN2803. The BAN2803 antibody also incorporates BioArctic's BrainTransporterTM technology. BioArctic will receive a $100 million upfront payment and up to $1.25 billion in milestone payments. BioArctic is also entitled to receive tiered royalties from global product sales.

Betta Pharmaceuticals' First China-Produced ALK Inhibitor Ensartinib Approved by FDA for Marketing:On December 18, the FDA approved Betta Pharmaceuticals' ALK inhibitor Ensacove (ensartinib) for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer.

Innovent Bio/Betta Pharmaceuticals ROS1 Inhibitor Approved for Marketing:On December 20, the latest announcement on the NMPA website showed that the listing application for adipic acid taletrectinib capsules (taletrectinib), submitted by Baoyuan Pharmaceuticals (now a subsidiary of Nuvation Bio), has been approved. Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI). Baoyuan Pharmaceuticals and Innovent Bio are jointly responsible for the development and commercialization of this product in Greater China. According to the announcement, the drug was approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed ROS1-TKI treatment.

Jixing and Sanofi Reach Agreement on Aficamten in the Greater China Market:On December 20, Sanofi and Jixing Pharmaceuticals jointly announced the signing of a formal agreement, under which Sanofi will acquire Jixing's exclusive rights to develop and commercialize aficamten in Greater China. The transaction is expected to be completed within 2024, and the transaction amount has not been disclosed. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA) have both accepted the new drug application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy.

Innovent Bio and Eli Lilly Reach Commercialization Collaboration on BTK Inhibitor:On December 16, Innovent Bio and Eli Lilly jointly announced that they had reached the following cooperation agreement regarding the rights to Eli Lilly's non-covalent (reversible) BTK inhibitor, Jayphalis (pirtobrutinib 100 mg and 50 mg tablets), in the Chinese market: Innovent Bio will be responsible for the import, sales, promotion, and distribution of Jayphalis; Eli Lilly will be responsible for the research and development of Jayphalis and post-marketing medical affairs-related work.

Henlius Introduces Glyco-editing Therapy:On December 19, Henlius announced that it had signed a collaboration and licensing agreement with Palleon Pharmaceuticals to develop and commercialize a combination therapy of Palleon's potential FIC human sialidase fusion protein E-602 and Henlius' self-developed Hanlikang (rituximab) for the treatment of autoimmune diseases, including lupus nephritis (LN). Under the terms of the agreement, Henlius has obtained the exclusive license for E-602 in China. Palleon is eligible to receive up to $95.3 million in development and commercialization milestone payments, as well as sales royalties after E-602 achieves commercialization in China.

Mesoblast's Global First Mesenchymal Stromal Cell Therapy Approved by FDA:On December 19, the U.S. FDA announced the approval of Mesoblast's Ryoncil (remestemcel) for marketing, indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged two months and older. This marks the first FDA-approved mesenchymal stromal cell (MSC) therapy.

EpimAb Biotherapeutics Establishes Research Collaboration to Develop Novel T-cell Engager Molecules:On December 16, EpimAb Biotherapeutics and Candid Therapeutics jointly announced a strategic research collaboration to discover and develop novel T-cell engaging molecule candidates for autoimmune indications. Under the terms of the agreement, if multiple drug candidates successfully advance to commercialization, EpimAb Biotherapeutics is eligible to receive an upfront payment and development and sales milestone payments totaling over $1 billion, along with royalties based on net sales. Candid Therapeutics holds global exclusive rights to develop and commercialize the collaboration programs.

Kunming Pharmaceutical Group Completes Acquisition of 51% Equity in CR Saintfire:On the evening of December 20, KPC Group announced that the company had completed the relevant industrial and commercial registration procedures for acquiring 51% of Kunming CR Sanjiu Holy Fire Pharmaceutical Co., Ltd. held by CR Sanjiu Medical and Pharmaceutical Co., Ltd. The completion of the acquisition of CR Holy Fire marks that KPC Group officially becomes the controlling shareholder of CR Holy Fire, which will become a member enterprise under KPC Group. The competition issue regarding Xuesaitong Soft Capsules between KPC Group and its controlling shareholder CR Sanjiu has been properly resolved in this transaction.

Mabwell Bioscience Plans to Go Public in Hong Kong:On the evening of December 15, Mabwell Biotherapeutics announced that the company plans to issue shares overseas (H shares) and list on the Main Board of the Hong Kong Stock Exchange. The company will complete this H-share issuance and listing at an appropriate time and issuance window within the validity period of the shareholders' meeting resolution. The company stated that, as of now, it is actively discussing the relevant work for this H-share issuance and listing with related intermediaries. Apart from the relevant proposals approved by this board meeting, other specific details regarding this H-share issuance and listing have not yet been determined.

PharmaCore Completes IPO Filing for Hong Kong Listing:On December 20, the China Securities Regulatory Commission confirmed the filing for PharmTek's IPO in Hong Kong. It is reported that PharmTek plans to issue no more than 146 million overseas-listed ordinary shares and list on the Hong Kong Stock Exchange. Thirty-four shareholders intend to convert their combined 286,385,673 unlisted domestic shares into overseas-listed shares, which will then be listed and traded on the Hong Kong Stock Exchange.

Yuneng Pharmaceutical Plans IPO on the Beijing Stock Exchange:On December 19, Jiangxi Yuneng Pharmaceutical Co., Ltd. completed IPO tutoring and acceptance, disclosing the completion report of tutoring work at the Jiangxi Securities Regulatory Bureau, with plans for a Beijing Stock Exchange IPO. The tutoring institution is Caitong Securities.

Haier Bio plans to merge with Shanghai RAAS by share exchange:On the evening of December 22, Haier Bio announced that the company and Shanghai RAAS are planning a merger by which Haier Bio will absorb Shanghai RAAS through the issuance of A-shares to all shareholders of Shanghai RAAS. Additionally, Haier Bio will issue A-shares to raise supporting funds. As this transaction is still in the planning stage and certain matters remain uncertain, to ensure fair information disclosure, protect investors' interests, and avoid abnormal fluctuations in the company’s stock price, according to the relevant regulations of the Shanghai Stock Exchange, the company has applied for a trading suspension. The company's securities are expected to be suspended from trading starting December 23, with an anticipated suspension period not exceeding 10 trading days.

First Trial | Huang Jia

Second Trial | Li Fangchen

Third Review | Li Jingzhi

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