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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 388 drug applications between 6 November 2025 and 12 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 49 drug names.

2025/11/06 – 2025/11/12

Period
2025/11/06 to 2025/11/12, 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
388
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
83

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

388filings, 70 of them generic

By application type

Application typeFilings
Supplement200
Generic70
New drug66
Import22
Import re-registration20
Unspecified10

By drug type

Drug typeFilings
Chemical drug221
TCM99
Therapeutic biologic58
Prophylactic biologic6
Biologic4

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefditoren Pivoxil Granules4218
2Finerenone Tablets3269
3奥氮平萨米多芬片 · No verified English name310
4氟比洛芬凝胶贴膏 · No verified English name2216
5Acetylcysteine Oral Solution2111
6利伐沙班干混悬剂 · No verified English name212
7Carboplatin Injection2110
8Vonoprazan Fumarate Tablets2160
9Lamotrigine Dispersible Tablets212
10氯化钾氯化钠注射液 · No verified English name214

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Shu Zhong Pharma Co., Ltd. romanized770
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized660
3Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized660
4AstraZeneca AB650
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
6Boehringer Ingelheim International GmbH620
7Bracco Imaging S.P.A.610
8Bayer AG540
9Takeda Development Center Americas Inc.520
10Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized520

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

114 this week

AcceptedDrugApplicants
2025/11/12Generic · Class 3 Idarubicin Hydrochloride InjectionCYHS2503934 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Acetylcysteine Oral SolutionCYHS2503933 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Acetylcysteine Oral SolutionCYHS2503932 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2503931 Suzhou Te Rui Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503930 Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503929 Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503928 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/11/12Generic · Class 3 Fosphenytoin Sodium InjectionCYHS2503927 Chengdu Brilliant Pharmaceutical Co., Ltd.
2025/11/12Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2503926 Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized; Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2503923 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500202 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500201 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/12Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2500200 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/12New drug · Class 1.1 运脾化痰通窍颗粒 · No verified English nameCXZL2500111 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/11/12New drug · Class 2.2 黄龙咳喘颗粒 · No verified English nameCXZL2500110 Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized
2025/11/12New drug · Class 1 注射用HDM2005 · No verified English nameCXSL2500964 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/11/12New drug · Class 1 QLS7305注射液 · No verified English nameCXHL2501250 Qilu Pharmaceutical Co., Ltd.
2025/11/12New drug · Class 1 QLS7305注射液 · No verified English nameCXHL2501249 Qilu Pharmaceutical Co., Ltd.
2025/11/12New drug · Class 2.4 玛仕度肽注射液 · No verified English nameCXHL2501245 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/12New drug · Class 2.4 玛仕度肽注射液 · No verified English nameCXHL2501244 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/12New drug · Class 2.4 玛仕度肽注射液 · No verified English nameCXHL2501243 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/12New drug · Class 2.4 玛仕度肽注射液 · No verified English nameCXHL2501242 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/12New drug · Class 2.3 LH-2417片 · No verified English nameCXHL2501241 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2025/11/12New drug · Class 2.3 LH-2417片 · No verified English nameCXHL2501240 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2025/11/12New drug · Class 2.3 LH-2417片 · No verified English nameCXHL2501239 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2025/11/12New drug · Class 2.3 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHL2501238 Jiangsu Ai Di Pharma Group Co., Ltd. romanized
2025/11/12New drug · Class 1 ZL-65片 · No verified English nameCXHL2501237 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/12New drug · Class 1 ZL-65片 · No verified English nameCXHL2501236 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/12New drug · Class 1 ZL-65片 · No verified English nameCXHL2501234 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/12New drug · Class 2.2; 2.4 CZ012凝胶 · No verified English nameCXHL2501233 Zhejiang Cui Ze Biopharmaceuticals Co., Ltd. romanized

84 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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