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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 26 May 2025 and 1 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 66 drug names.

2025/05/26 – 2025/06/01

Period
2025/05/26 to 2025/06/01, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
42

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

341filings, 89 of them generic

By application type

Application typeFilings
Supplement171
Generic89
New drug51
Import13
Unspecified8
Import re-registration8
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug209
TCM72
Therapeutic biologic47
Prophylactic biologic9
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection7753
2Nicardipine Hydrochloride Injection3213
3Brexpiprazole Tablets3131
4Glucosamine Sulfate Capsules2251
5维生素B6注射液 · No verified English name2210
6利伐沙班口崩片 · No verified English name214
7利伐沙班颗粒 · No verified English name212
8复方氨基酸注射液(20AA-Ⅱ) · No verified English name210
9Levothyroxine Sodium Tablets2112
10Loxoprofen Sodium Patches2130

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized13110
2Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized950
3Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized656
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
5Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550
6Haerbin Tong Yi Tang Pharma Co., Ltd. romanized440
7Quan Zhou Zhong Qiao Pharma Co., Ltd. romanized440
8Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized440
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
10CISEN PHARMACEUTICAL CO., LTD.420

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

90 this week

AcceptedDrugApplicants
2025/05/31Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2501949 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/05/31Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2501948 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized
2025/05/31Generic · Class 3 Salbutamol Sulfate injectionCYHS2501947 Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/05/31Generic · Class 3 Flurbiprofen PatchesCYHS2501944 Hunan Jiudian Pharmaceutical Co., Ltd
2025/05/31Generic · Class 3 Tobramycin Sulfate InjectionCYHS2501943 Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2501942 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 Terbutaline Sulfate InjectionCYHL2500102 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized
2025/05/31Generic · Class 3 Dapsone GelCYHL2500101 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/05/31New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2500023 Rui Yang Pharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 注射用STSP-0601 · No verified English nameCXSS2500057 Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized; Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 3.2 ACYW???群脑膜炎球菌多糖结合疫苗 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CXSS2500056 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 SM2275注射液 · No verified English nameCXSL2500443 Zhuhai Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/31New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500442 Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 注射用YL201 · No verified English nameCXSL2500441 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/05/31New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2500440 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 2.4 BAT4706注射液 · No verified English nameCXSL2500439 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2500438 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/31New drug · Class 1 伊托法替布软膏 · No verified English nameCXHS2500058 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2025/05/31New drug · Class 2.2 HEC20002胶囊 · No verified English nameCXHL2500527 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2025/05/30Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSS2500070 Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd.
2025/05/30Import · Class 1 PF-08046047 · No verified English nameJXSL2500085 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500083 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501936 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501930 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501929 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501927 Nanjing Hai Jing Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2501926 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2501925 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/30New drug · Class 3.3 雷珠单抗注射液 · No verified English nameCXSS2500055 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized

60 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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