YaoGeJu

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

Period
2024/10/16 to 2024/10/22, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement143
Generic88
New drug68
Import22
Unspecified13
Import re-registration5

By drug type

Drug typeFilings
Chemical drug197
TCM70
Therapeutic biologic55
Biologic10
Prophylactic biologic7

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection3213
2匹伐他汀钙口崩片 · No verified English name310
3Bromhexine Hydrochloride Injection228
4Metoclopramide Hydrochloride Injection226
5Tacrolimus Sustained-release Capsules216
6Lamotrigine Extended Release Tablets210
7氯雷他定糖浆 · No verified English name217
8Loxoprofen Sodium Patches2130
9Mesalazine Gastro-Resistant Prolonged-Release Granules213
10醋酸去氨加压素片 · No verified English name216

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)FilingsDrugsGeneric
1Novo Nordisk A/S1120
2Eli Lilly and Company720
3Shenyang Dong Xin Pharma Co., Ltd. romanized660
4Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized660
5Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660
6AstraZeneca AB530
7Name not romanized430
8Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized420
9Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized410
10Jin Yao Da Ren Tang Jing Wan Hong (Tianjin) Pharma Co., Ltd. romanized330

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

AcceptedDrugApplicants
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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