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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 460 drug applications between 7 July 2026 and 13 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 54 drug names.

2026/07/07 – 2026/07/13

Period
2026/07/07 to 2026/07/13, 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
460
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
134

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

460filings, 65 of them generic

By application type

Application typeFilings
Supplement253
New drug85
Generic65
Import31
Unspecified17
Import re-registration9

By drug type

Drug typeFilings
Chemical drug232
TCM134
Therapeutic biologic81
Biologic7
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

54 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

292 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
2Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized760
3Novo Nordisk A/S720
4Shanxi Ao Er Pharma Co., Ltd. romanized660
5Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized630
6Amgen Inc.610
7Liquidia Technologies Inc.610
8Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized610
9Gui Lin San Jin Pharma Co., Ltd. romanized540
10Patheon France510

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

141 this week

AcceptedDrugApplicants
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
2026/07/13New drug · Class 3.1 当归饮子颗粒 · No verified English nameCXZS2600036 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized
2026/07/13New drug · Class 1.1 糖宁通络乳膏 · No verified English nameCXZL2600060 Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized
2026/07/13New drug · Class 1 Sac002注射液 · No verified English nameCXSL2600735 Zhong Mei Sai Er Bio Technology (Guangdong) Co., Ltd. romanized
2026/07/13New drug · Class 1 HS-20117-2注射液 · No verified English nameCXSL2600734 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/07/13New drug · Class 1 注射用AK158D1 · No verified English nameCXSL2600733 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2026/07/13New drug · Class 1 BNT317注射液 · No verified English nameCXSL2600732 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/07/13New drug · Class 1 Cizutamig注射液(皮下注射) · No verified English nameCXSL2600731 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/13New drug · Class 2.4 苯磺酸克利加巴林胶囊 · No verified English nameCXHS2600102 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/07/13New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2600846 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2026/07/13New drug · Class 1 ABP-745缓释片A · No verified English nameCXHL2600845 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2026/07/13New drug · Class 1 ABP-745缓释片B · No verified English nameCXHL2600844 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2026/07/13New drug · Class 2.3 EP-0229T · No verified English nameCXHL2600843 Chengdu Shuo De Pharma Co., Ltd. romanized
2026/07/13New drug · Class 1 BCR-0008片 · No verified English nameCXHL2600842 Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized

111 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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