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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 268 drug applications between 31 May 2025 and 6 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 51 drug names.

2025/05/31 – 2025/06/06

Period
2025/05/31 to 2025/06/06, 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
268
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
49

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

268filings, 78 of them generic

By application type

Application typeFilings
Supplement124
Generic78
New drug49
Import7
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug162
TCM57
Therapeutic biologic43
Biologic3
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection6653
2Safinamide Methansulfonate Tablets4220
3Dapagliflozin Tablets4284
4Sodium Nitroprusside Injection3215
5Minoxidil Liniment3252
6Paliperidone Palmitate Injection318
7Sevelamer Carbonate Powder for oral suspension223
8Tadalafil Tablets2123
9利伐沙班颗粒 · No verified English name212
10Zoledronic Acid Injection212

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized1060
2Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized540
3Jiangxi Ke Rui Pharma Co., Ltd. romanized430
4Janssen-Cilag International NV420
5Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized410
6Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized330
7Rui Yang Pharmaceutical Co., Ltd. romanized331
8Bai Ao Tai Biopharmaceutical Co., Ltd. romanized330
9Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized330
10Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized323

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

86 this week

AcceptedDrugApplicants
2025/06/06Import · Class 1 Clesrovimab注射液 · No verified English nameJXSS2500071 Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd.
2025/06/06Import · Class 1 JSB462片 · No verified English nameJXHL2500128 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/06Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500127 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/06Import · Class 2.2; 2.4 TAR-210 · No verified English nameJXHL2500125 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/06/06Generic · Class 3 Vitamin K1 InjectionCYHS2502012 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2025/06/06Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502011 Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2025/06/06Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2502009 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized
2025/06/06Generic · Class 3 Acetylcysteine TabletsCYHS2502008 Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized
2025/06/06Generic · Class 3 Zoledronic Acid InjectionCYHS2502005 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/06/06Generic · Class 3 Minoxidil LinimentCYHS2502003 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/06/06Generic · Class 3 Minoxidil LinimentCYHS2502002 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/06/06Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501999 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2025/06/06Generic · Class 3 维生素D口服溶液 · No verified English nameCYHL2500105 Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized
2025/06/06New drug · Class 2.3 黄厚止泻滴丸 · No verified English nameCXZL2500035 Anhui Lei Yun Shang Pharma Co., Ltd. romanized
2025/06/06New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSS2500060 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2025/06/06New drug · Class 1 TI-0093注射液 · No verified English nameCXSL2500461 Yuan Yin (Beijing) Bio Technology Co., Ltd. romanized
2025/06/06New drug · Class 1 LYN101注射液 · No verified English nameCXSL2500456 Shanghai Cai Zhi Yao Cheng Bio Technology Co., Ltd. romanized
2025/06/06New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2500455 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/06/06New drug · Class 3.3 度普利尤单抗注射液 · No verified English nameCXSL2500453 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/06/06New drug · Class 3.3 度普利尤单抗注射液 · No verified English nameCXSL2500452 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/06/06New drug · Class 1 UC101 CAR-T细胞注射液 · No verified English nameCXSL2500451 Chengdu You Sai Nuo Bio Technology Co., Ltd. romanized
2025/06/06New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500450 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/06/06New drug · Class 1 WJ22096片 · No verified English nameCXHL2500543 Nanjing Jing Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/06/06New drug · Class 1 WJ22096片 · No verified English nameCXHL2500542 Nanjing Jing Ao Biopharmaceuticals Technology Co., Ltd. romanized
2025/06/06New drug · Class 1 HRS-4508片 · No verified English nameCXHL2500541 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/06New drug · Class 1 HRS-4508片 · No verified English nameCXHL2500540 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/06New drug · Class 2.2 SN007干混悬剂 · No verified English nameCXHL2500539 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2025/06/06New drug · Class 1 QL-H118片 · No verified English nameCXHL2500538 Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized
2025/06/06New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500537 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/06/05Generic · Class 3 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501998 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

56 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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