YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 339 drug applications between 16 October 2024 and 22 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 72 drug names.
2024/10/16 – 2024/10/22
- New acceptances this week
- 339
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 4
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
339filings, 88 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 88 |
| New drug | 68 |
| Import | 22 |
| Unspecified | 13 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 70 |
| Therapeutic biologic | 55 |
| Biologic | 10 |
| Prophylactic biologic | 7 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 3 | 2 | 13 |
| 2 | 匹伐他汀钙口崩片 · No verified English name | 3 | 1 | 0 |
| 3 | Bromhexine Hydrochloride Injection | 2 | 2 | 8 |
| 4 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 5 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 6 | Lamotrigine Extended Release Tablets | 2 | 1 | 0 |
| 7 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Mesalazine Gastro-Resistant Prolonged-Release Granules | 2 | 1 | 3 |
| 10 | 醋酸去氨加压素片 · No verified English name | 2 | 1 | 6 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 2 | 0 |
| 2 | Eli Lilly and Company | 7 | 2 | 0 |
| 3 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Name not romanized | 4 | 3 | 0 |
| 8 | Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jin Yao Da Ren Tang Jing Wan Hong (Tianjin) Pharma Co., Ltd. romanized | 3 | 3 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
127 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/22Import · Class 1 | RO7790121注射液 · No verified English nameJXSL2400198 | F. Hoffmann-La Roche Ltd. |
| 2024/10/22Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2403556 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2403554 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Indobufen TabletsCYHS2403553 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Bilastine Oral SolutionCYHS2403551 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Amisulpride InjectionCYHS2403550 | Hubei Duo Rui Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Bumetanide InjectionCYHS2403549 | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Bumetanide InjectionCYHS2403548 | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | 二甲双胍格列吡嗪片 · No verified English nameCYHS2403546 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Lidocaine and Tetracaine CreamCYHS2403544 | Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized; Shandong Liang Fu Pharmaceutical Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Lamotrigine Extended Release TabletsCYHL2400207 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Lamotrigine Extended Release TabletsCYHL2400206 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2024/10/22Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHL2400205 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | IMS001注射液 · No verified English nameCXSL2400716 | Zhuhai Heng Qin Ai Mu Si Tan Bio Technology Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | SCG142自体T细胞注射液 · No verified English nameCXSL2400715 | Xing Yuan De Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Xing Han De (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | CL01阴道胶囊 · No verified English nameCXHL2401123 | Hong Hua (Beijing) Technology Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | CL01阴道胶囊 · No verified English nameCXHL2401122 | Hong Hua (Beijing) Technology Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | CL01阴道胶囊 · No verified English nameCXHL2401121 | Hong Hua (Beijing) Technology Co., Ltd. romanized |
| 2024/10/22New drug · Class 2.2 | KLA480注射液 · No verified English nameCXHL2401120 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | 安脑三醇注射液 · No verified English nameCXHL2401119 | Guangzhou Shi Sai Pu Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/22New drug · Class 1 | 氟[18F]吡酰胺注射液 · No verified English nameCXHL2401118 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2024/10/21New drug · Class 1 | 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2400714 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2024/10/21New drug · Class 1 | SYH2059片 · No verified English nameCXHL2401117 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/21New drug · Class 1 | SYH2059片 · No verified English nameCXHL2401116 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/20Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2403542 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2400713 | Name not romanized; Name not romanized |
| 2024/10/19New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2401115 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2401114 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | ART101注射液 · No verified English nameCXHL2401113 | Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | AK-1286片 · No verified English nameCXHL2401112 | Shanghai Ying Li Pharma Co., Ltd. romanized |
97 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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