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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 292 drug applications between 14 June 2022 and 20 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 33 drug names.

2022/06/14 – 2022/06/20

Period
2022/06/14 to 2022/06/20, 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
292
Drugs with new generic filings (by drug name, de-duplicated)
33
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

292filings, 41 of them generic

By application type

Application typeFilings
Supplement157
New drug47
Generic41
Import19
Import re-registration18
Unspecified10

By drug type

Drug typeFilings
Chemical drug205
Therapeutic biologic53
TCM29
Prophylactic biologic4
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment3252
2Vonoprazan Fumarate Tablets2160
3Pregabalin Capsules2112
4注射用头孢噻肟钠他唑巴坦钠 · No verified English name211
5Rasagiline Mesylate Tablets215
6Dapoxetine Hydrochloride Tablets2120
7苯磺酸左氨氯地平片 · No verified English name2145
8二甲硅油乳剂 · No verified English name1114
9Tadalafil Tablets1123
10Linagliptin 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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1020
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
3Janssen-Cilag International NV830
4Lian Cardiovascular Limited510
5The Wellcome Foundation Limited510
6Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
7LES LABORATOIRES SERVIER430
8Hetero Labs Limited420
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD421
10Hainan Ling Kang Pharmaceutical Co., Ltd. romanized420

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

72 this week

AcceptedDrugApplicants
2022/06/20Import · Class 1 替拉扎明注射液 · No verified English nameJXHL2200140 Raygene Inc.; Hangzhou Taibo Pharmaceutical Company Ltd.
2022/06/20New drug · Class 1.1 AC591颗粒 · No verified English nameCXZL2200029 Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized
2022/06/20New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSL2200283 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2022/06/20New drug · Class 1 CM369注射液 · No verified English nameCXSL2200282 Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized
2022/06/20New drug · Class 2.2 人干扰素α2b阴道泡腾胶囊 · No verified English nameCXSL2200281 Ke Xing Biopharmaceutical Co., Ltd. romanized
2022/06/20New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSL2200280 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized
2022/06/20New drug · Class 1 重组全人源抗EGFR单克隆抗体注射液 · No verified English nameCXSL2200279 Shanghai Sai Yuan Bio Technology Co., Ltd. romanized
2022/06/20New drug · Class 1 EVT-401片 · No verified English nameCXHL2200403 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2022/06/20New drug · Class 1 EVT-401片 · No verified English nameCXHL2200402 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2022/06/20New drug · Class 2.2 HRG2101吸入剂 · No verified English nameCXHL2200400 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/06/20New drug · Class 2.2 注射用左西孟旦 · No verified English nameCXHL2200397 Hainan Brilliant Pharmaceutical Co., Ltd.
2022/06/17Import · Class 2.1 Isatuximab注射液(皮下注射) · No verified English nameJXSL2200088 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2022/06/17Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2200087 Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd.
2022/06/17Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2200086 Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd.
2022/06/17Import · Class 1 M1774胶囊 · No verified English nameJXHL2200151 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Import · Class 1 M1774胶囊 · No verified English nameJXHL2200150 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Import · Class 1 M1774胶囊 · No verified English nameJXHL2200149 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2022/06/17Generic · Class 3 Hydrotalcite SuspensionCYHS2200912 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/06/17Generic · Class 3 多种微量元素注射液(Ⅰ) · No verified English nameCYHS2200906 Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/06/17Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2200904 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/06/17Generic · Class 3 Minoxidil LinimentCYHS2200901 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2022/06/17Generic · Class 3 Minoxidil LinimentCYHS2200900 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2022/06/17New drug · Class 1.1 心阳片 · No verified English nameCXZL2200028 Guangzhou Zhong Pharmaceuticals University Di Yi Fu Shu Hospital romanized
2022/06/17New drug · Class 1 6MW3511注射液 · No verified English nameCXSL2200278 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/06/17New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2200273 Liaoning Cheng Da Bio Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2022/06/17New drug · Class 1 QA102 胶囊 · No verified English nameCXHL2200399 Zhuhai Qi Wei Bio Technology Co., Ltd. romanized
2022/06/17New drug · Class 1 QA102 胶囊 · No verified English nameCXHL2200398 Zhuhai Qi Wei Bio Technology Co., Ltd. romanized
2022/06/17New drug · Class 1 SPH3127片 · No verified English nameCXHL2200396 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2022/06/17New drug · Class 1 SPH3127片 · No verified English nameCXHL2200395 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2022/06/16Import · Class 3.1 注射用Susoctocog alfa · No verified English nameJXSS2200020 Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd

42 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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