YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 232 drug applications between 16 November 2021 and 22 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 26 drug names.

2021/11/16 – 2021/11/22

Period
2021/11/16 to 2021/11/22, 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
232
Drugs with new generic filings (by drug name, de-duplicated)
26
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

232filings, 38 of them generic

By application type

Application typeFilings
Supplement117
Generic38
New drug37
Import22
Import re-registration11
Unspecified7

By drug type

Drug typeFilings
Chemical drug175
Therapeutic biologic27
TCM25
Biologic3
Prophylactic biologic2

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name313
2Sildenafil Citrate Oral Disintegrating Tablets228
3Sodium Valproate Concentrated Solution for Injection210
4Ozagrel Sodium Injection213
5Obeticholic Acid Tablets210
6Bisoprolol Fumarate Tablets216
7Tolvaptan Tablets210
8Tandospirone Citrate Tablets212
9Aminophylline Injection213
10Cytarabine for Injection212

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

140 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized990
2Actelion Pharmaceuticals Ltd810
3Da Lian Tian Shan Pharma Co., Ltd. romanized660
4Upjohn Manufacturing Ireland Unlimited610
5Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized440
6Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized420
7Upjohn US 2 LLC410
8Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized410
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320
10Ji Chuan Pharma Group 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
2021/11/22Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2101032 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 3.1 赖脯胰岛素注射液 · No verified English nameJXSS2101031 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101135 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/11/22Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHL2101246 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHL2101245 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Generic · Class 3 Oxytocin InjectionCYHS2102059 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized
2021/11/22New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101434 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2021/11/22New drug · Class 2.2 重组人源化抗VEGF单克隆抗体注射液 · No verified English nameCXSL2101433 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2021/11/22New drug · Class 1 人肌母细胞注射液 · No verified English nameCXSL2101432 Luo Gai Ji Mu Xi Bao Yi Xue Research Institute Wuhan Co., Ltd. romanized
2021/11/22New drug · Class 2.2 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101431 Xiamen Li Zhuo Pharma Co., Ltd. romanized
2021/11/22New drug · Class 1 AK115注射液 · No verified English nameCXSL2101430 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 AK115注射液 · No verified English nameCXSL2101429 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 注射用IAP0971 · No verified English nameCXSL2101428 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2021/11/22New drug · Class 1 SHR7280片 · No verified English nameCXHL2101679 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 SHR7280片 · No verified English nameCXHL2101678 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/11/22New drug · Class 1 注射用SYHA1908 · No verified English nameCXHL2101677 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/11/22New drug · Class 1 HZ010注射液 · No verified English nameCXHL2101676 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2021/11/19Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2102028 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/11/19New drug · Class 3.2 人抗凝血酶Ⅲ · No verified English nameCXSS2101053 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2021/11/19New drug · Class 1 泰特利单抗注射液 · No verified English nameCXSS2101052 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/11/19New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101427 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/19New drug · Class 1 FZJ-003胶囊 · No verified English nameCXHL2101675 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/11/19New drug · Class 1 BPI-442096片 · No verified English nameCXHL2101669 Bei Da Pharma Co., Ltd. romanized
2021/11/19New drug · Class 1 BPI-442096片 · No verified English nameCXHL2101668 Bei Da Pharma Co., Ltd. romanized
2021/11/19New drug · Class 1 HS301片 · No verified English nameCXHL2101667 Han Hui Pharmaceutical Co., Ltd. romanized
2021/11/19New drug · Class 1 HS301片 · No verified English nameCXHL2101666 Han Hui Pharmaceutical Co., Ltd. romanized
2021/11/18Import · Class 1 司柏索利单抗注射液 · No verified English nameJXSS2101030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/18Import · Class 1 注射用Dapirolizumab Pegol单抗 · No verified English nameJXSL2101134 UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd
2021/11/18Generic · Class 3 Aminophylline InjectionCYHS2102047 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized
2021/11/18Generic · Class 3 Aminophylline InjectionCYHS2102046 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized

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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