YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 313 drug applications between 12 June 2022 and 18 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.

2022/06/12 – 2022/06/18

Period
2022/06/12 to 2022/06/18, 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
313
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

313filings, 49 of them generic

By application type

Application typeFilings
Supplement167
Generic49
New drug40
Import26
Import re-registration21
Unspecified10

By drug type

Drug typeFilings
Chemical drug221
Therapeutic biologic50
TCM35
Biologic4
Prophylactic biologic3

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
1Minoxidil Liniment3252
2Pravastatin Sodium Tablets212
3Pregabalin Capsules2112
4注射用头孢噻肟钠他唑巴坦钠 · No verified English name211
5Pantoprazole Enteric-Coated Tablets211
6Rasagiline Mesylate Tablets215
7Dopamine Hydrochloride Injection213
8Dapoxetine Hydrochloride Tablets2120
9Minoxidil Topical Solution210
10苯磺酸左氨氯地平片 · No verified English name2145

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1020
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
3Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized540
4Janssen-Cilag International NV530
5Qilu Pharmaceutical Co., Ltd.531
6Lian Cardiovascular Limited510
7The Wellcome Foundation Limited510
8Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
9LES LABORATOIRES SERVIER430
10F. Hoffmann-La Roche Ltd420

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

76 this week

AcceptedDrugApplicants
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
2022/06/16Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2200148 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/16Import · Class 2.4 Tacrolimus Eye DropsJXHL2200147 SENJU PHARMACEUTICAL CO. LTD.; Name not romanized
2022/06/16Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2200896 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/06/16Generic · Class 3 Minoxidil LinimentCYHS2200895 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/06/16Generic · Class 3 Fluorouracil InjectionCYHS2200893 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 1 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2200277 Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized
2022/06/16New drug · Class 1 TG103注射液 · No verified English nameCXSL2200276 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200275 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 1 HXYT-001细胞注射液 · No verified English nameCXSL2200274 Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Beijing Qing Yi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized
2022/06/16New drug · Class 1 尘螨过敏原舌下含片 · No verified English nameCXSL2200272 Ge Lin Mian Yi Ke Xue Co., Ltd. romanized
2022/06/16New drug · Class 1 尘螨过敏原舌下含片 · No verified English nameCXSL2200271 Ge Lin Mian Yi Ke Xue Co., Ltd. romanized

46 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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