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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 105 drug applications between 29 April 2022 and 5 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 12, covering 11 drug names.

2022/04/29 – 2022/05/05

Period
2022/04/29 to 2022/05/05, 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
105
Drugs with new generic filings (by drug name, de-duplicated)
11
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

105filings, 12 of them generic

By application type

Application typeFilings
Supplement53
New drug25
Generic12
Import12
Unspecified3

By drug type

Drug typeFilings
Chemical drug70
TCM20
Therapeutic biologic11
Prophylactic 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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nifedipine Controlled-release Tablets227
2Ipratropium Bromide Inhalation Solution112
3Ibuprofen Injection118
4Tinidazole Tablets110
5氧(液态) · No verified English name1113
6Piperacillin Sodium for Injection1116
7Roxatidine Acetate Hydrochloride For Injection115
8Doxorubicin Hydrochloride Liposome Injection112
9Sitagliptin Phosphate Tablets112
10Roxithromycin Tablets112

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

65 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1UNION therapeutics A/S620
2Henan Tai Long Pharma Co., Ltd. romanized550
3Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized440
4Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized420
5MINGHUI PHARMACEUTICAL PTY LTD410
6Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
7Le Pu Pharma Co., Ltd. romanized310
8Jiangsu Hao Sen Pharma Group Co., Ltd. romanized310
9Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized220
10Beijing Lang Di Pharmaceutical Co., Ltd. romanized220

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

40 this week

AcceptedDrugApplicants
2022/05/05Import · Class 1 Orismilast 缓释片 · No verified English nameJXHL2200100 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200099 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200098 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast 缓释片 · No verified English nameJXHL2200097 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200096 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Import · Class 1 Orismilast缓释片 · No verified English nameJXHL2200095 UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd.
2022/05/05Generic · Class 3 Tinidazole TabletsCYHS2200698 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/05/05Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2200696 Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/05/05New drug · Class 1.1 参味宁郁片 · No verified English nameCXZS2200005 Guangdong Si Ji Pharma Co., Ltd. romanized; Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized
2022/05/05New drug · Class 1 GZR4 · No verified English nameCXSL2200192 Gan Li Pharma Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200022 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200021 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 1 培莫沙肽注射液 · No verified English nameCXHS2200020 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2022/05/05New drug · Class 2.2; 2.4 BM201注射液 · No verified English nameCXHL2200273 Suzhou Bai Mai Biopharmaceuticals Co., Ltd. romanized
2022/05/05New drug · Class 1 HS248片 · No verified English nameCXHL2200272 Han Hui Pharmaceutical Co., Ltd. romanized
2022/05/05New drug · Class 1 HS248片 · No verified English nameCXHL2200271 Han Hui Pharmaceutical Co., Ltd. romanized
2022/05/05New drug · Class 2.2 环孢素滴眼液 · No verified English nameCXHL2200262 Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200094 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200093 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200092 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏 · No verified English nameJXHL2200091 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200694 Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/04/29Generic · Class 3 Doxorubicin Hydrochloride Liposome InjectionCYHS2200689 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2022/04/29Generic · Class 3 Ibuprofen InjectionCYHS2200644 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/04/29New drug · Class 1.2 甘草总查耳酮胶囊 · No verified English nameCXZL2200021 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2022/04/29New drug · Class 1.2 甘草总查耳酮 · No verified English nameCXZL2200020 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2022/04/29New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2200049 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200048 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200047 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2022/04/29New drug · Class 1 拓培非格司亭注射液 · No verified English nameCXSS2200046 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized

10 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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