YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 235 drug applications between 5 November 2021 and 11 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 37 drug names.

2021/11/05 – 2021/11/11

Period
2021/11/05 to 2021/11/11, 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
235
Drugs with new generic filings (by drug name, de-duplicated)
37
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

235filings, 47 of them generic

By application type

Application typeFilings
Supplement124
Generic47
New drug33
Import19
Unspecified9
Import re-registration3

By drug type

Drug typeFilings
Chemical drug163
Therapeutic biologic41
TCM28
Prophylactic biologic2
Biologic1

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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dexmedetomidine Hydrochloride Injection320
2泊沙康唑注射液 · No verified English name221
3Tacrolimus Capsules212
4Sodium Hyaluronate Eye Drops2130
5盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
6Terbutaline Sulfate Injection212
7Sugammadex Sodium Injection216
8阿普米司特片 · No verified English name213
9Ranolazine Prolonged-Release Tablets213
10Sodium Valproate Oral Solution111

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

152 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized870
2Hunan Wei Er Qiang Pharmaceutical Co., Ltd. romanized640
3Hunan De Kang Pharmaceutical Co., Ltd. romanized550
4Hangzhou Minsheng Pharmaceutical Co., Ltd532
5Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized520
6Zhejiang Zan Sheng Pharma Co., Ltd. romanized440
7Novartis Europharm Limited420
8Eli Lilly Nederland B.V.410
9Takeda Manufacturing Austria AG410
10Jiangxi Qing Feng Pharma 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

64 this week

AcceptedDrugApplicants
2021/11/11Import · Class 1 SAR444245注射液 · No verified English nameJXSL2101126 Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2021/11/11Import · Class 1 Gepotidacin片 · No verified English nameJXHL2101241 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102009 Topfond Pharmaceutical Co., Ltd.
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102006 Hangzhou Minsheng Pharmaceutical Co., Ltd
2021/11/11Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102005 Hangzhou Minsheng Pharmaceutical Co., Ltd
2021/11/11New drug · Class 1.1 白热斯丸 · No verified English nameCXZL2101032 Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Pharmaceuticals Research Institute romanized
2021/11/11New drug · Class 1 GR1803注射液 · No verified English nameCXSL2101420 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/11/11New drug · Class 1 STI-6129注射液 · No verified English nameCXSL2101419 Zhejiang Ai Sen Pharma Co., Ltd. romanized
2021/11/11New drug · Class 1 AK112注射液 · No verified English nameCXSL2101417 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/11New drug · Class 1 CS0159片 · No verified English nameCXHL2101645 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/11/11New drug · Class 1 CS0159片 · No verified English nameCXHL2101644 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/11/11New drug · Class 1 CS0159片 · No verified English nameCXHL2101643 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/11/11New drug · Class 1 OB756片 · No verified English nameCXHL2101642 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/11/11New drug · Class 1 KL340399注射液 · No verified English nameCXHL2101635 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/11/11New drug · Class 1 KL340399注射液 · No verified English nameCXHL2101634 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/11/10Generic · Class 3 Terbutaline Sulfate InjectionCYHS2102002 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2021/11/10Generic · Class 3 Terbutaline Sulfate InjectionCYHS2102000 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2021/11/10Generic · Class 3 Calcium Gluconate InjectionCYHS2101999 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2021/11/10Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101998 Shenzhen Da Fu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2021/11/10Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101997 Shenzhen Da Fu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2021/11/10New drug · Class 1 Zilovertamab vedotin注射液 · No verified English nameCXSL2101418 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2021/11/10New drug · Class 1 AK117注射液 · No verified English nameCXSL2101416 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/10New drug · Class 1 HSK31679片 · No verified English nameCXHL2101641 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2021/11/10New drug · Class 1 HSK31679片 · No verified English nameCXHL2101640 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2021/11/10New drug · Class 1 ACT001胶囊 · No verified English nameCXHL2101639 Xin Yi Shang De Yao Yuan Pharma Co., Ltd. romanized
2021/11/09Import · Class 1 DS-1062a · No verified English nameJXSL2101124 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/11/09Import · Class 2.4 盐酸替洛利生薄膜衣片 · No verified English nameJXHL2101239 BIOPROJET PHARMA; Citrine(Shanghai) Co.Ltd
2021/11/09Import · Class 2.4 盐酸替洛利生薄膜衣片 · No verified English nameJXHL2101238 BIOPROJET PHARMA; Citrine(Shanghai) Co.Ltd
2021/11/09Import · Class 1 BI 690517片 · No verified English nameJXHL2101237 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/09Import · Class 1 BI 690517片 · No verified English nameJXHL2101236 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.

34 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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