YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 198 drug applications between 1 July 2021 and 7 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 19 drug names.

2021/07/01 – 2021/07/07

Period
2021/07/01 to 2021/07/07, 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
198
Drugs with new generic filings (by drug name, de-duplicated)
19
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

198filings, 31 of them generic

By application type

Application typeFilings
Supplement104
Generic31
New drug31
Import24
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug147
TCM25
Therapeutic biologic19
Prophylactic biologic6
In vitro diagnostic reagent1

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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets7323
2Perindopril tert-Butylamine Tablets215
3Levetiracetam Tablets216
4Procaterol Hydrochloride Oral Solution2112
5Lidocaine Hydrochloride Injection216
6Dabigatran Etexilate Capsules212
7Febuxostat Tablets2112
8Risperidone Oral Solution116
9噻托溴铵吸入粉雾剂 · No verified English name112
10头孢丙烯干混悬剂 · No verified English name112

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

104 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Liang Ji Pharma Co., Ltd. romanized14140
2AstraZeneca AB730
3Jiangsu Guang Cheng Pharma Co., Ltd. romanized660
4Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized660
5Zhejiang Hui Di Sen Pharma Co., Ltd. romanized620
6GlaxoSmithKline Biologicals SA410
7MINGHUI PHARMACEUTICAL PTY LTD410
8Yunnan Xian Shi Pharma Co., Ltd. romanized414
9Jiangsu Zhang Tai Pharma Co., Ltd. romanized410
10Merck Sharp & Dohme B.V.320

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

60 this week

AcceptedDrugApplicants
2021/07/06Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2101065 F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2021/07/06Import · Class 1 AZD5305 · No verified English nameJXHL2101120 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/06Import · Class 1 AZD5305 · No verified English nameJXHL2101119 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/06Import · Class 1 AZD5305 · No verified English nameJXHL2101118 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2021/07/06Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101117 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/07/06Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2101399 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2021/07/06Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2101398 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2021/07/06New drug · Class 1.2 广金钱草总黄酮提取物 · No verified English nameCXZS2101004 Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized
2021/07/06New drug · Class 1 JWCAR129(靶向BCMA嵌合抗原受体T细胞) · No verified English nameCXSL2101172 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2021/07/06New drug · Class 1 CMS203片 · No verified English nameCXHL2101265 Name not romanized
2021/07/06New drug · Class 1 CMS203片 · No verified English nameCXHL2101264 Name not romanized
2021/07/06New drug · Class 1 AL8326片 · No verified English nameCXHL2101263 Nanjing Ai De Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101116 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101115 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片 · No verified English nameJXHL2101114 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101113 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101112 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101111 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏 · No verified English nameJXHL2101110 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 Belzutifan片 · No verified English nameJXHL2101109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2021/07/05Generic · Class 3 Mesalamine extended release capsulesCYHS2101385 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2021/07/05Generic · Class 3 Pregabalin Extended release TabletsCYHL2101017 Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized
2021/07/05New drug · Class 1.1 脑脉通颗粒 · No verified English nameCXZL2101016 Guangdong Yao Ke University romanized
2021/07/05New drug · Class 1 普特利单抗注射液 · No verified English nameCXSS2101008 Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2021/07/05New drug · Class 1 注射用QLF31907 · No verified English nameCXSL2101171 Qilu Pharmaceutical Co., Ltd.
2021/07/05New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2101170 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2021/07/05New drug · Class 1 注射用BJ-005 · No verified English nameCXSL2101168 Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2021/07/05New drug · Class 1 HS-10241片 · No verified English nameCXHL2101262 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/05New drug · Class 1 HS-10241片 · No verified English nameCXHL2101261 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/05New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHL2101260 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized

30 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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