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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 463 drug applications between 11 September 2026 and 17 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 43 drug names.

2026/09/11 – 2026/09/17

Period
2026/09/11 to 2026/09/17, 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
463
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
401

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

463filings, 60 of them generic

By application type

Application typeFilings
Supplement264
New drug103
Generic60
Import21
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug209
TCM156
Therapeutic biologic91
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

43 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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized960
2Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized870
3Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized770
4F. Hoffmann-La Roche Ltd720
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized650
7Novo Nordisk A/S620
8Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized620
9Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized620
10Novartis Pharma AG530

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

142 this week

AcceptedDrugApplicants
2026/09/17Import · Class 1 PF-08046876 · No verified English nameJXSL2600249 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/17Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602313 Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized
2026/09/17New drug · Class 1 IBI3043 · No verified English nameCXSL2601020 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/17New drug · Class 2.2 注射用波米泰酶α · No verified English nameCXSL2601019 Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 1 ASP1002注射液 · No verified English nameCXSL2601018 An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/09/17New drug · Class 1 ASP1002注射液 · No verified English nameCXSL2601017 An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/09/17New drug · Class 1 注射用HX111 · No verified English nameCXSL2601016 Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2026/09/17New drug · Class 1 YH001胶囊 · No verified English nameCXHL2601166 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/09/17New drug · Class 1 YH001胶囊 · No verified English nameCXHL2601165 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2026/09/17New drug · Class 1 RSS0343胶囊 · No verified English nameCXHL2601164 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/09/17New drug · Class 1 RSS0343胶囊 · No verified English nameCXHL2601163 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/09/17New drug · Class 1 RSS0343胶囊 · No verified English nameCXHL2601162 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/09/17New drug · Class 1 RSS0343胶囊 · No verified English nameCXHL2601161 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2026/09/17New drug · Class 1 注射用SR14肽 · No verified English nameCXHL2601160 Zhongguo Ke College Kunming Dong Wu Research Institute romanized
2026/09/17New drug · Class 1 IKT-001片 · No verified English nameCXHL2601159 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/09/17New drug · Class 2.4 Daraxonrasib片 · No verified English nameCXHL2601158 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 2.4 Daraxonrasib片 · No verified English nameCXHL2601157 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 2.4 Daraxonrasib片 · No verified English nameCXHL2601156 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 2.4 Daraxonrasib片 · No verified English nameCXHL2601155 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 2.2 LP095口颊膜 · No verified English nameCXHL2601154 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2026/09/17New drug · Class 2.2 LP095口颊膜 · No verified English nameCXHL2601153 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2026/09/17New drug · Class 2.2 LP095口颊膜 · No verified English nameCXHL2601152 Li Pin Pharma (Xiamen) Co., Ltd. romanized
2026/09/17New drug · Class 1 TQB3306 片 · No verified English nameCXHL2601151 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/17New drug · Class 1 TQB3306片 · No verified English nameCXHL2601150 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/17New drug · Class 2.4 林普利塞片 · No verified English nameCXHL2601149 Shanghai Ying Li Pharma Co., Ltd. romanized
2026/09/16Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2600248 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/16Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2600247 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/16Import · Class 2.2 斯贝利单抗注射液(皮下注射) · No verified English nameJXSL2600246 Otsuka Pharmaceutical Development & Commercialization Inc.; Otsuka Beijing Research Institute
2026/09/16Import · Class 2.2 斯贝利单抗注射液(皮下注射) · No verified English nameJXSL2600245 Otsuka Pharmaceutical Development & Commercialization Inc.; Otsuka Beijing Research Institute
2026/09/16Import · Class 1 DKB903注射用浓溶液 · No verified English nameJXSL2600244 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

112 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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