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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 257 drug applications between 30 July 2023 and 5 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 33 drug names.

2023/07/30 – 2023/08/05

Period
2023/07/30 to 2023/08/05, 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
257
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
0

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

257filings, 47 of them generic

By application type

Application typeFilings
Supplement146
Generic47
New drug39
Import15
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug157
TCM71
Therapeutic biologic29

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets3170
2Sitagliptin Phosphate Tablets312
3Palbociclib Tablets212
4Multiple Electrolytes Injection(Ⅱ)211
5Topiroxostat Tablets210
6注射用头孢唑肟钠 · No verified English name214
7Bendamustine Hydrochloride For Injection212
8Neostigmine Methylsulfate Injection214
9Tapentadol Hydrochloride Extended Release Tablets210
10Mirabegron Extended-release Tablets211

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Qing Gong Pharma Group Co., Ltd. romanized29290
2Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized20180
3Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized910
4Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized870
5Xian Jing Xi Shuang He Pharma Co., Ltd. romanized710
6Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized660
7China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.630
8Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized440
9Sichuan He Zong Ze Hui Pharmaceuticals Technology Co., Ltd. romanized440
10Zydus Lifesciences Limited420

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

65 this week

AcceptedDrugApplicants
2023/08/02Import · Class 3.1 Brolucizumab注射液 · No verified English nameJXSS2300068 Novartis Europharm Ltd.; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd.
2023/08/02Import · Class 3.1 Brolucizumab注射液 · No verified English nameJXSS2300067 Novartis Europharm Ltd.; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2023/08/02Import · Class 2.2 DS-8201a · No verified English nameJXSL2300149 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/08/02Import · Class 2.4 Ritlecitinib胶囊 · No verified English nameJXHL2300182 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/08/02Import · Class 2.4 Ritlecitinib胶囊 · No verified English nameJXHL2300181 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/08/02Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2302067 Shenzhen Da Fu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/02Generic · Class 3 Ebastine Oral SolutionCYHS2302066 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized
2023/08/02Generic · Class 3 Minoxidil LinimentCYHS2302063 Guangdong Quan Xin Quan Yi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/02Generic · Class 3 Minoxidil LinimentCYHS2302062 Guangdong Quan Xin Quan Yi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/02Generic · Class 3 Tapentadol Hydrochloride Extended Release TabletsCYHL2300096 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/08/02Generic · Class 3 Tapentadol Hydrochloride Extended Release TabletsCYHL2300095 Jiangsu En Hua Pharma Co., Ltd. romanized
2023/08/02New drug · Class 1 悬铃木花粉点刺液 · No verified English nameCXSS2300064 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2023/08/02New drug · Class 1 猫毛皮屑点刺液 · No verified English nameCXSS2300063 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2023/08/02New drug · Class 1 德国小蠊点刺液 · No verified English nameCXSS2300062 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2023/08/02New drug · Class 1 全人源抗破伤风毒素单克隆抗体A82/B86注射液组合制剂 · No verified English nameCXSL2300536 Changchun Bai Ke Bio Technology Shareholding Company romanized
2023/08/02New drug · Class 1 靶向CD19和CD22的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2300535 Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized
2023/08/02New drug · Class 2.1 替雷利珠单抗注射液(皮下注射) · No verified English nameCXSL2300534 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2023/08/02New drug · Class 1 HB0017注射液 · No verified English nameCXSL2300533 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/02New drug · Class 2.4 Roxadustat CapsulesCXHS2300068 Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/08/02New drug · Class 2.4 Roxadustat CapsulesCXHS2300067 Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/08/02New drug · Class 1 磷酸安泰他韦胶囊 · No verified English nameCXHS2300066 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2023/08/02New drug · Class 2.2 注射用罗替高汀缓释微球 · No verified English nameCXHS2300065 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2023/08/02New drug · Class 2.2 注射用罗替高汀缓释微球 · No verified English nameCXHS2300064 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2023/08/02New drug · Class 2.2 注射用罗替高汀缓释微球 · No verified English nameCXHS2300063 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2023/08/02New drug · Class 2.2 注射用罗替高汀缓释微球 · No verified English nameCXHS2300062 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2023/08/02New drug · Class 1 LT-002-158片 · No verified English nameCXHL2300853 Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/02New drug · Class 1 LT-002-158片 · No verified English nameCXHL2300852 Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/02New drug · Class 1 盐酸钩吻素子片 · No verified English nameCXHL2300851 Fujian Yi Ke University romanized
2023/08/02New drug · Class 1 盐酸钩吻素子片 · No verified English nameCXHL2300850 Fujian Yi Ke University romanized
2023/08/01Import · Class 1 注射用佐妥昔单抗 · No verified English nameJXSS2300066 Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd.

35 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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