YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 236 drug applications between 4 November 2021 and 10 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 38 drug names.

2021/11/04 – 2021/11/10

Period
2021/11/04 to 2021/11/10, 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
236
Drugs with new generic filings (by drug name, de-duplicated)
38
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

236filings, 46 of them generic

By application type

Application typeFilings
Supplement128
Generic46
New drug30
Import19
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug167
Therapeutic biologic46
TCM19
Prophylactic biologic3
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1氧(液态) · No verified English name2213
2泊沙康唑注射液 · No verified English name221
3Amlodipine Besylate and Atorvastatin Calcium Tablets212
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
7阿普米司特片 · No verified English name213
8Ranolazine Prolonged-Release Tablets213
9ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name110
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

151 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized710
2Guangdong Ke Lun Pharma Co., Ltd. romanized610
3Hunan De Kang Pharmaceutical Co., Ltd. romanized550
4UCB Pharma SA520
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
10Hangzhou Minsheng Pharmaceutical Co., Ltd320

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

57 this week

AcceptedDrugApplicants
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.
2021/11/09Generic · Class 3 Colesevelam Hydrochloride TabletsCYHS2101982 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2021/11/09Generic · Class 3 Amisulpride InjectionCYHL2101038 Beijing Pu De Kang Li Pharmaceuticals Technology Development Co., Ltd. romanized
2021/11/09New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2101044 Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized
2021/11/09New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2101043 Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized
2021/11/09New drug · Class 3.3 CMAB807X注射液 · No verified English nameCXSL2101413 Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized
2021/11/09New drug · Class 1 CM350 · No verified English nameCXSL2101412 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2021/11/09New drug · Class 2.2 PDX-02 · No verified English nameCXHL2101638 Hunan Jiudian Pharmaceutical Co., Ltd
2021/11/09New drug · Class 2.4 Chidamide TabletsCXHL2101637 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/11/09New drug · Class 2.2 富马酸伏诺拉生注射液 · No verified English nameCXHL2101636 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/11/09New drug · Class 1 FZJ-003胶囊 · No verified English nameCXHL2101633 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/11/09New drug · Class 1 FZJ-003胶囊 · No verified English nameCXHL2101632 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/11/08Import · Class 1 PH94B 鼻用喷雾剂 · No verified English nameJXHL2101235 VistaGen Therapeutics Inc.
2021/11/08Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHS2101987 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2021/11/08Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHS2101986 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2021/11/08Generic · Class 3 Levofloxacin InjectionCYHS2101981 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized

27 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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