On the afternoon of July 19, China Resources Double-Crane Pharmaceutical Co., Ltd. signed an exclusive sales agency contract with Zhongtian (Shanghai) Biotechnology Co., Ltd. and Holistic Bio-Tech Co., Ltd., obtaining the 20-year exclusive agency rights for Xiang Lei Tang Zu Gao (Subeiyi) in mainland China. This will greatly improve the accessibility of the "Subeiyi" drug, benefiting more diabetic patients and injecting new vitality into the joint development of new drugs across the Taiwan Strait.According to the contract, China Resources Double-Crane will first pay up to approximately US$34 million (about NT$1.12 billion) as a signing fee to Zhongtian Shanghai, of which about US$6.8 million will depend on the medical insurance results.

"Subeone" obtained the first Class 1.1 new natural drug approval in China in November 2023, and it is also the first specific new drug for diabetic foot ulcers in mainland China.According to the 2021 data from the International Diabetes Federation (IDF), the number of adult diabetes patients in China has reached 141 million. Among Chinese diabetes patients aged 50 and above, the incidence rate of diabetic foot is as high as 8.1%, with a total amputation rate of 19.03%, representing a significant unmet medical need.

As the first Class 1.1 natural drug in China and the first targeted new drug for treating diabetic foot ulcers, "Subi-1" has undergone a 15-year development process. Its innovative mechanism of action lies in reshaping the wound microenvironment, balancing M1/M2 macrophages, promoting the transformation of diabetic foot ulcers into normal wounds, and accelerating the healing process. This breakthrough therapy has gained widespread international recognition, including the FDA's "Fast Track" designation in the United States, as well as pharmaceutical registration in mainland China, Taiwan, Singapore, and Malaysia. Compared with traditional treatment methods, "Subi-1" is convenient to use and offers significant economic advantages. Additionally, the drug demonstrates high safety, providing patients with a safer and more comfortable treatment experience.

On August 30, Jacobio announced the KRAS G12C inhibitor Glecirasib and the SHP2 inhibitor JAB-3312.Greater China rights licensed to Allist Pharmaceuticals, Jacobio retains global rights outside Greater China. According to the agreement,Allist Pharmaceuticals paid 150 million yuan as an upfront payment, 50 million yuan as compensation for R&D expenses, and other payments, 700 million yuan in development and sales milestone amounts, along with a double-digit percentage of sales royalties. The maximum sales royalty for JAB-3312 is 20%.

Glecirasib (JAB-21822), independently developed by Jacobio, is a KRAS G12C inhibitor primarily used for the treatment of patients with advanced solid tumors harboring the KRAS G12C mutation. The New Drug Application (NDA) for Glecirasib as a second-line treatment for non-small cell lung cancer (NSCLC) with the KRAS G12C mutation was granted priority review on May 21, 2024. In December 2022, Glecirasib was designated as a breakthrough therapy by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for second-line and above treatment of patients with advanced or metastatic NSCLC carrying the KRAS G12C mutation. In April 2024, Jacobio presented data from the Phase II pivotal clinical trial of Glecirasib at the ASCO Plenary Series, showing a confirmed objective response rate (cORR) of 47.9% (56/117) in second-line NSCLC patients, including 4 patients achieving complete response (CR) and 36 patients experiencing tumor shrinkage of over 50%. The disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and the median overall survival (mOS) was 13.6 months.

JAB-3312 is a selective allosteric inhibitor of SHP2, a key node in the RAS signaling pathway. It is the world's only SHP2 inhibitor to enter phase III trials and has received orphan drug designation from the U.S. FDA for esophageal cancer (including esophageal squamous cell carcinoma).

On August 2, Huadong Medicine and Beijing Yimiaoshenzhou Medical Techology Co., Ltd. announced that they have reached a commercialization collaboration in mainland China regarding the latter’s autologous CAR-T candidate product IM19 chimeric antigen receptor T-cell injection (hereinafter referred to as “IM19 Injection”), which targets CD19. According to the agreement terms,Beijing Yimiaoshenzhou Medical Techology Co., Ltd. will receive an upfront payment of 125 million RMB and is entitled to receive registration and sales milestone payments of up to 950 million RMB.Beijing Yimiaoshenzhou Medical Techology Co., Ltd. will continue to be responsible for the development, registration, and production of IM19 injection in mainland China.

The product for this bid — IM19 Chimeric Antigen Receptor T-Cell Injection,It is the first CAR-T cell therapy product independently developed by Beijing Yimiaoshenzhou Medical Techology Co., Ltd.It has successively obtained clinical trial approval notices for three indications from the National Medical Products Administration, namely, relapsed/refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma, all of which have entered the registration clinical research stage.

Among them, the research on the end-line treatment of diffuse large B-cell lymphoma is about to complete Phase II clinical trials (confirmatory clinical trials), with good clinical efficacy and safety data. The research on acute B lymphoblastic leukemia and mantle cell lymphoma has completed the reinfusion of all subjects in Phase I and is about to enter Phase II clinical trials. In the future, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. also plans to conduct clinical trials for second-line treatment of diffuse large B-cell lymphoma. The scope of this collaboration covers the treatment of all B-cell hematological malignancies, including relapsed or refractory diffuse large B-cell lymphoma, acute B lymphoblastic leukemia, and mantle cell lymphoma.

IM19 CAR-T Cell Injection is expected to submit its marketing application in the fourth quarter of 2024 and, once launched, is likely to rank among the first group of domestically produced CAR-T cell therapy drugs in China., effectively filling the market gap for domestically produced CAR-T products in lymphoma indications, bringing new hope to hundreds of thousands of lymphoma patients in China.

On January 8, Yuanyi Biotechnology announced an exclusive collaboration and licensing agreement with Praxis Precision Medicines (hereinafter referred to as Praxis).Yuanyi Biotechnology (Shanghai) Co., Ltd. will develop and commercialize ulixacaltamide for the treatment of essential tremor in the Greater China region.As part of the cooperation agreement,Praxis will receive an upfront payment of $15 million, including $5 million in cash and a $10 million investment in common stock.. In addition, Praxis is expected to receive$264 million in development, regulatory, and commercialization milestone payments,And tiered royalties on net sales in Greater China.

Ulixacaltamide is aA highly selective T-type calcium channel small molecule inhibitor designed to block abnormal neuronal burst firing in the cerebello-thalamo-cortical (CTC) circuit associated with tremor activity.. The product is currently in Phase 3 clinical trials in the United States for the treatment of essential tremor. In previous Phase 2 clinical trials, researchers observed additional benefits when ulixacaltamide was added to propranolol in patients with essential tremor.

On April 17, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the New Drug Application for ulixacaltamide extended-release tablets, submitted by Praxis, had received implied approval for clinical trials. The drug is intended for the treatment of Essential Tremor (ET).

On May 21, Grand Pharmaceutical Group Limited (0512.HK) andLianBioLianBio and Tarsus Pharmaceuticals, Inc. (Tarsus) have reached a strategic product introduction cooperation agreement.Upon the satisfaction of relevant conditions, Grand Pharmaceutical Group Limited will acquire the exclusive rights for the development, production, and commercialization of TP-03, a globally innovative ophthalmic formulation for the treatment of Demodex blepharitis and Demodex-induced meibomian gland dysfunction, in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) for an upfront payment of US$15 million and certain registration milestone fees.

TP-03 is a selective non-competitive antagonist of the γ-aminobutyric acid-gated chloride channel (GABA-Cl). It induces paralysis and death in mites by selectively inhibiting GABA-Cl within the Demodex mite, thereby completely curing Demodex blepharitis. Additionally, TP-03 is highly lipophilic, promoting its absorption into the oily environment of the eyelash follicles where mites reside.

TP-03 has completed two pivotal clinical studies in the United States, enrolling more than 800 patients with Demodex blepharitis. According to the clinical results, both studies met the primary endpoint and all secondary endpoints with statistical significance, and no serious treatment-related adverse events occurred.The product was approved for marketing by the U.S. Food and Drug Administration (FDA) in July 2023. It is currently the first and only FDA-approved drug for Demodex blepharitis.In addition, the Phase II clinical study of TP-03 conducted in the United States for the treatment of meibomian gland dysfunction caused by Demodex mites has also shown positive topline results.

In terms of registration in China, TP-03 has completed Phase III clinical research. According to the study results, compared with the control group, TP-03 demonstrated a statistically significant eradication rate (p<0.001) for Demodex infections in patients with Demodex blepharitis. The cure rate for sleeve-like secretions on the eyelids also showed a positive but not statistically significant trend (p=0.15). In addition, TP-03 was well tolerated and its safety profile was similar to the results observed in other large-scale clinical trials, with no treatment-related discontinuations. Upon completion of this transaction, Grand Pharmaceutical Group Limited will vigorously advance the registration process of TP-03 in China to benefit a wide range of patients with Demodex blepharitis as soon as possible.

On April 25, Hansoh Pharma announced that it had entered into a licensing agreement with Quanxin Biotech. Hansoh Pharma will obtain an exclusive license from Quanxin Biotech to...Develop and commercialize QX004N monoclonal antibody in China (including Hong Kong, Macao, and Taiwan regions).

According to the agreement, Hansoh Pharma will be responsible for the research and development, production, and commercialization of all developable dosage forms and indications of QX004N in China.Payment of RMB 75 million as the upfront payment and up to RMB 1.032 billion in potential milestone payments related to R&D, regulatory, and sales-based commercialization., as well as tiered royalties based on future product sales.

QX004N Injection is a recombinant humanized IgG1 monoclonal antibody that specifically binds to human IL-23. It belongs to Class 1 innovative therapeutic biologics and is currently undergoing Phase II clinical trials for psoriasis and Phase Ia clinical trials for Crohn's disease. QX004N exerts its therapeutic effects by specifically binding to the p19 subunit of human IL-23, blocking the interaction between extracellular IL-23 and the IL-23 receptor on the cell surface, and inhibiting the release of pro-inflammatory cytokines and chemokines mediated by IL-23.

On August 2, Mabwell announced that its Taikang Biologics and Runjie Pharmaceuticals have reached an agreement on the research varieties.RP901 Project License Agreement SignedAccording to the agreement, Runjia Medicine grants Taikang Bio the rights to research, develop (including research or development through contract research organizations), register, commercialize, and sell the RP901 project and its companion diagnostics (developed solely for the purpose of using the licensed product) within the Greater China region (including mainland China, Hong Kong, Macao, and Taiwan).

RP901 is aPotential First-in-class Small Molecule Drug in the Field of Osteoarthritis (OA) TreatmentIt is intended to be developed as a Class 1 new drug for the oral treatment of osteoarthritis. After being orally administered into the human body, it can accumulate in the joint cavity, improving cartilage damage in osteoarthritis patients by enhancing cartilage synthesis metabolism and reducing cartilage degradation metabolism, thereby exerting a therapeutic effect on osteoarthritis. Preclinical efficacy studies have shown that it has a clear bone-protective and osteoarthritis-improving effect; preclinical pharmacokinetic studies have shown that RP901 has high oral bioavailability in rats and monkeys, and studies using isotope labeling have indicated good distribution of RP901 in osteoarthritis-targeted organs. Preclinical safety and Phase I clinical trial results have shown that RP901 has good safety. A Phase II clinical study of RP901 tablets for the treatment of knee osteoarthritis is currently being conducted in China.Mabwell has already launched two drugs in the orthopedics field, namely Maiwei Jian® (bone tumor field) and Maiwei Shu® (osteoporosis field). This collaboration will further expand Mabwell's product portfolio in the bone health sector.

On August 14, Huadong Medicine's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., and IMBiologics (a South Korean biotechnology company focused on developing innovative products for autoimmune diseases and cancer),Announcement of an exclusive strategic cooperation agreement for the development, registration, production, and commercialization of IMB-101 and IMB-102 (hereinafter referred to as the "licensed products") in 37 Asian countries including China (excluding Japan, South Korea, and North Korea) (hereinafter referred to as the "licensed territory").

According to the terms of the agreement, IMBiologicsWill receive an upfront payment of 6 million US dollars, a technology transfer milestone payment of 2 million US dollars, and development, registration, and sales milestone payments of up to 307.5 million US dollars., as well as tiered royalties of up to double-digit percentages on net sales.

Huadong Medicine will be responsible for the development, registration, production, and commercialization of the licensed products in the licensed region. IMBiologics will continue to be responsible for the development and commercialization of IMB-101 and IMB-102 in other regions. This transaction will take effect from the date of signing the agreement.

IMB-101 is a bispecific antibody targeting OX40L and TNFα, involved in regulating inflammatory cytokines, promoting T cell and plasma cell differentiation, as well as autoantibody production, maintaining immune homeostasis balance. In 2023, IMBiologics submitted the IND application for IMB-101 to the U.S. Food and Drug Administration (FDA) and received approval. The drug is currently undergoing Phase I clinical trials in the United States for the proposed treatment of rheumatoid arthritis.

IMB-102 is a monoclonal antibody targeting OX40L, currently in the preclinical research stage, with potential indications including moderate to severe atopic dermatitis and other autoimmune diseases.

February 14,Brii BiosciencesAnnouncement withVBI Vaccines, Inc. ("VBI", NASDAQ: VBIV) to secure and control the future clinical and commercial supply of BRII-179. BRII-179 is a late-stage clinical product in Brii Biosciences' functional cure portfolio for hepatitis B (HBV).

According to the agreement,Brii Biosciences will initially issue a promissory note of $2.5 million to VBI, which will eliminate royalties and milestone payments related to PreHevbri. Upon meeting specific conditions, the note will increase to $10 million to acquire all intellectual property rights of VBI in BRII-179, and all payments related to BRII-179 will also be eliminated.In addition, after meeting specific conditions, Brii Biosciences will collaborate with VBI to transfer the production technology of BRII-179 to a manufacturing base designated by Brii Biosciences.

BRII-179 (VBI-2601) is a novel HBV immunotherapy candidate based on recombinant protein, expressing Pre-S1, Pre-S2, and S HBV surface antigens, designed to induce enhanced and broad B-cell and T-cell immune responses. As part of a potential functional cure for chronic HBV infection, Brii Biosciences is conducting two Phase 2 studies: one combining BRII-179 with BRII-835 (VIR-2218), and the other combining BRII-179 with PEG-IFNα.

Brii Biosciences introduced BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018, obtaining commercialization rights in China, including mainland China, Hong Kong, Macao, and Taiwan. The company also expanded the exclusive license for BRII-179 to the global market starting from July 2023. In November 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted BRII-179 Breakthrough Therapy Designation.

February 28,JIUDIAN PHARMACEUTICAL Successfully Signs Patent and Technology Transfer Agreement for Antibacterial and Anti-inflammatory Peptides with Zonsen PepLibCompared with small molecule drugs, polypeptide drugs have the advantages of high selectivity, high activity and high safety. They have been widely used in the fields of cardiovascular diseases, central nervous system diseases, respiration, anti-tumor and immunomodulation, and anti-infection, etc. They can complement large molecule antibody drugs and small molecule drugs well and have broad market space.

The polypeptide molecules in this project possess dual functions of antibacterial and anti-inflammatory properties.JIUDIAN PHARMACEUTICAL will obtain the exclusive global rights for further development, production, and commercialization of the aforementioned peptide candidate drug under this project. It will also hold the global exclusive rights for the patent in the broader health fields, including medical aesthetics.