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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 419 drug applications between 17 October 2025 and 23 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 53 drug names.

2025/10/17 – 2025/10/23

Period
2025/10/17 to 2025/10/23, 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
419
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
101

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

419filings, 70 of them generic

By application type

Application typeFilings
Supplement251
New drug72
Generic70
Import11
Unspecified10
Import re-registration5

By drug type

Drug typeFilings
Chemical drug271
TCM80
Therapeutic biologic59
Biologic6
Prophylactic biologic3

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules4451
2Dapagliflozin Tablets3284
3Clindamycin Injection214
4呋喃妥因胶囊 · No verified English name214
5Digoxin Injection213
6Imipenem and Cilastatin Sodium for Injection216
7注射用托伐普坦磷酸钠 · No verified English name2115
8Safinamide Methansulfonate Tablets2120
9Promethazine Hydrochloride Injection2111
10盐酸昂丹司琼口服溶液 · 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

233 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized41330
2Boehringer Ingelheim International GmbH1230
3Jiangsu Si Jia Wei Kang Pharmaceuticals Technology Co., Ltd. romanized910
4Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
5Sanofi-Aventis Recherche & Développement730
6Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized660
7Topfond Pharmaceutical Co., Ltd.550
8Tong Hua Si Wei Pharma Co., Ltd. romanized550
9Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized540
10Sichuan Kelun Pharmaceutical Co., Ltd.532

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

112 this week

AcceptedDrugApplicants
2025/10/23Import · Class 1 BI764198 片 · No verified English nameJXHL2500328 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/10/23Import · Class 1 Balinatunfib · No verified English nameJXHL2500322 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/10/23Import · Class 1 Balinatunfib · No verified English nameJXHL2500321 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/10/23Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2503777 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 Oxytocin InjectionCYHS2503776 Wuhan Ren Fu Pharma Co., Ltd. romanized
2025/10/23Generic · Class 3 Oxytocin InjectionCYHS2503775 Wuhan Ren Fu Pharma Co., Ltd. romanized
2025/10/23Generic · Class 3 Clindamycin InjectionCYHS2503768 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 Clindamycin InjectionCYHS2503767 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/10/23Generic · Class 3 利非司特滴眼液 · No verified English nameCYHL2500190 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2025/10/23New drug · Class 1 注射用QLS2313 · No verified English nameCXSL2500921 Qilu Pharmaceutical Co., Ltd.
2025/10/23New drug · Class 1.2 RSV mRNA疫苗(JCXH-108注射液) · No verified English nameCXSL2500920 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2025/10/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500919 Jiangsu Sai Yi Bio Technology Co., Ltd. romanized
2025/10/23New drug · Class 2.2 复方α-酮酸颗粒 · No verified English nameCXHS2500128 Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized
2025/10/23New drug · Class 1 HS-10365胶囊 · No verified English nameCXHS2500127 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2025/10/23New drug · Class 1 注射用RAB001 · No verified English nameCXHL2501164 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized
2025/10/23New drug · Class 1 IGS01片 · No verified English nameCXHL2501163 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/23New drug · Class 1 IGS01片 · No verified English nameCXHL2501162 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/23New drug · Class 1 IGS01片 · No verified English nameCXHL2501161 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/23New drug · Class 1 IGS01片 · No verified English nameCXHL2501160 Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/10/23New drug · Class 2.4 羟钴胺注射液 · No verified English nameCXHL2501159 Hua Run Shuang He Pharma Co., Ltd. romanized
2025/10/23New drug · Class 2.4; 2.2 羟钴胺注射液 · No verified English nameCXHL2501158 Hua Run Shuang He Pharma Co., Ltd. romanized
2025/10/23New drug · Class 2.4; 2.2 羟钴胺注射液 · No verified English nameCXHL2501157 Hua Run Shuang He Pharma Co., Ltd. romanized
2025/10/22Import · Class 3.1 艾普奈珠单抗注射用浓溶液 · No verified English nameJXSS2500134 Lundbeck Seattle BioPharmaceuticals Inc.; Vetter Pharma-Fertigung GmbH & Co.KG; Lundbeck (Beijing) Pharmaceuticals Consulting Co. Ltd.
2025/10/22Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2503760 Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized
2025/10/22Generic · Class 3 Furosemide Oral SolutionCYHS2503758 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2025/10/22Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2503757 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/10/22Generic · Class 3 Acetylcysteine TabletsCYHS2503754 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2025/10/22New drug · Class 3.1 半夏白术天麻颗粒 · No verified English nameCXZS2500047 Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2025/10/22New drug · Class 3.1 真武汤颗粒 · No verified English nameCXZS2500046 Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized
2025/10/22New drug · Class 1.1 舒肝安胃颗粒 · No verified English nameCXZL2500102 Beijing Wei Wei Kang Technology Co., Ltd. romanized

82 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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