YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 504 drug applications between 11 August 2026 and 17 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 57 drug names.

2026/08/11 – 2026/08/17

Period
2026/08/11 to 2026/08/17, 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
504
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
238

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

504filings, 77 of them generic

By application type

Application typeFilings
Supplement309
Generic77
New drug67
Import40
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug251
TCM165
Therapeutic biologic80
Prophylactic biologic5
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

57 drugs with new generic filings; top 10 listed

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

278 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Min Wei Bio Technology Co., Ltd. romanized1410
2F. Hoffmann-La Roche Ltd1330
3Jilin Gao Miao Pharma Co., Ltd. romanized990
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized930
5AstraZeneca AB850
6Yi Chang Ren Fu Pharma Co., Ltd. romanized844
7Guangdong Tai En Kang Pharmaceutical Factory Co., Ltd. romanized830
8Novo Nordisk A/S820
9Xin Da Bio Technology Co., Ltd. romanized810
10Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized772

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

134 this week

AcceptedDrugApplicants
2026/08/17Import · Class 1 VAY736注射液 · No verified English nameJXSL2600208 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/17Import · Class 1 ALPN-303注射液 · No verified English nameJXSL2600207 Vertex Pharmaceuticals Incorporated; Name not romanized
2026/08/17Import · Class 1 CDR132L注射液 · No verified English nameJXHL2600346 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/17Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2602035 Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized
2026/08/17Generic · Class 3 螺内酯片 · No verified English nameCYHS2602033 Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD
2026/08/17Generic · Class 3 螺内酯片 · No verified English nameCYHS2602032 Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD
2026/08/17Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2602030 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2026/08/17Generic · Class 3 Bilastine Orally disintegrating TabletsCYHS2602029 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized
2026/08/17Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602027 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2026/08/17Generic · Class 3 Indobufen TabletsCYHS2602023 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2026/08/17New drug · Class 1.1 天葛定眩颗粒 · No verified English nameCXZL2600077 Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2026/08/17New drug · Class 2.2 安尼妥单抗注射液 · No verified English nameCXSS2600126 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2026/08/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600125 Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized
2026/08/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600124 Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized
2026/08/17New drug · Class 1 SHR-1139注射液 · No verified English nameCXSL2600876 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/17New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600875 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/08/17New drug · Class 1 SZ1003注射液 · No verified English nameCXSL2600874 Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized
2026/08/17New drug · Class 2.2 艾米迈托赛注射液 · No verified English nameCXSL2600873 Bo Sheng Zhuo Yue Bio Technology (Beijing) Co., Ltd. romanized
2026/08/17New drug · Class 1 注射用Efimosfermin alfa · No verified English nameCXSL2600872 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2026/08/17New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600871 Changchun Tuo Hua Pharmaceuticals Co., Ltd. romanized
2026/08/17New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600870 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/08/17New drug · Class 2.2 注射用多西他赛(白蛋白结合型) · No verified English nameCXHS2600118 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2026/08/17New drug · Class 1 SIM0518胶囊 · No verified English nameCXHL2601010 Shanghai Xian Sheng Zai Ming Technology Co., Ltd. romanized
2026/08/17New drug · Class 1 SIM0518胶囊 · No verified English nameCXHL2601009 Shanghai Xian Sheng Zai Ming Technology Co., Ltd. romanized
2026/08/17New drug · Class 1 68Ga-NRT6020注射液 · No verified English nameCXHL2601008 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600345 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600344 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600343 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600342 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600341 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.

104 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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