YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 465 drug applications between 8 July 2026 and 14 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 50 drug names.

2026/07/08 – 2026/07/14

Period
2026/07/08 to 2026/07/14, 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
465
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
131

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

465filings, 57 of them generic

By application type

Application typeFilings
Supplement268
New drug80
Generic57
Import31
Unspecified21
Import re-registration8

By drug type

Drug typeFilings
Chemical drug230
TCM145
Therapeutic biologic76
Biologic8
Prophylactic biologic6

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

50 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

285 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1020
2Shanxi Ao Er Pharma Co., Ltd. romanized990
3Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized870
4Novo Nordisk A/S720
5Amgen Inc.610
6Liquidia Technologies Inc.610
7Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized610
8Shanxi Huang He Zhong Yao Co., Ltd. romanized550
9Gui Lin San Jin Pharma Co., Ltd. romanized540
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD532

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

136 this week

AcceptedDrugApplicants
2026/07/14Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2600164 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/14Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2600163 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/14Generic · Class 3 Mepivacaine Hydrochloride InjectionCYHS2601677 Guangdong Sunho Pharmaceutical Co., Ltd.
2026/07/14Generic · Class 3 Minoxidil LinimentCYHS2601676 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/07/14Generic · Class 3 Minoxidil LinimentCYHS2601675 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/07/14New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2600737 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/07/14New drug · Class 1 TQB2922注射液(皮下注射) · No verified English nameCXSL2600736 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/07/14New drug · Class 1 HRS-4729注射液 · No verified English nameCXHL2600852 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 HRS-4729注射液 · No verified English nameCXHL2600851 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2600850 Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2600849 Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized
2026/07/14New drug · Class 2.3 BTP0427 · No verified English nameCXHL2600848 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2026/07/14New drug · Class 2.3 BTP0427 · No verified English nameCXHL2600847 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2026/07/13Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2600062 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600162 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600161 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600160 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600159 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600158 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 AMG 133 · No verified English nameJXSL2600157 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600272 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600271 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600270 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600269 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/13Generic · Class 3 盐酸奥洛他定口崩片 · No verified English nameCYHS2601670 Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized
2026/07/13Generic · Class 3 Clemastine Fumarate InjectionCYHS2601666 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/07/13Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601664 Hebei Shan Mu Shi Pharma Co., Ltd. romanized
2026/07/13Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601663 Hebei Shan Mu Shi Pharma Co., Ltd. romanized
2026/07/13Generic · Class 3 唑尼沙胺胶囊 · No verified English nameCYHS2601662 Hunan Shang Zhong He Biopharmaceuticals Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2026/07/13Generic · Class 3 Pirfenidone TabletsCYHS2601659 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized

106 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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