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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 14 October 2026 and 20 October 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 59, covering 44 drug names.

2026/10/14 – 2026/10/20

Period
2026/10/14 to 2026/10/20, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
323
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
288

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

323filings, 59 of them generic

By application type

Application typeFilings
Supplement155
New drug79
Generic59
Import13
Unspecified11
Import re-registration6

By drug type

Drug typeFilings
Chemical drug172
TCM82
Therapeutic biologic60
Biologic5
Prophylactic biologic4

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

44 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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1450
2Changchun Jin Sai Pharma Co., Ltd. romanized620
3Shanxi Huang He Zhong Yao Co., Ltd. romanized550
4Medice Arzneimittel Pütter GmbH & Co. KG510
5Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized430
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
8Li Lai Suzhou Pharmaceutical Co., Ltd. (Bi Xin Manufacturing) romanized410
9Shandong Xin Shi Dai Pharma Co., Ltd. romanized330
10Cheng De Tian Yuan Pharma Co., Ltd. romanized330

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

110 this week

AcceptedDrugApplicants
2026/10/20Import · Class 1 Tilrekimig注射液 · No verified English nameJXSL2600276 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/10/20New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2601149 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/10/20New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2601148 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/10/20New drug · Class 2.3 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHS2600142 Jiangsu Ai Di Pharma Group Co., Ltd. romanized
2026/10/20New drug · Class 1 注射用BPI-585771 · No verified English nameCXHL2601308 Bei Da Pharma Co., Ltd. romanized
2026/10/19Import · Class 2.2 塔奎妥单抗注射液 · No verified English nameJXSS2600097 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2026/10/19Import · Class 2.2 塔奎妥单抗注射液 · No verified English nameJXSS2600096 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2026/10/19Import · Class 1 ASP2138注射液 · No verified English nameJXSL2600275 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/10/19Import · Class 1 Alnuctamab注射液 · No verified English nameJXSL2600274 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/19Import · Class 1 Alnuctamab注射液 · No verified English nameJXSL2600273 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/19Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2602574 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2026/10/19Generic · Class 3 Avanafil TabletsCYHS2602570 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2026/10/19Generic · Class 3 Avanafil TabletsCYHS2602569 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2026/10/19Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2602564 Hubei Duo Rui Pharma Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2026/10/19Generic · Class 3 Diphenhydramine Hydrochloride TabletsCYHS2602562 Henan Lang Guan Medicines Formulations Research Institute Co., Ltd. romanized; Anhui Hua Chen Pharmaceutical Co., Ltd. romanized
2026/10/19New drug · Class 2.3 济川煎颗粒 · No verified English nameCXZL2600101 Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized; Anhui Sheng Shi Pin Medicines Jian Yan Research Institute romanized
2026/10/19New drug · Class 1 SHR-5670注射液 · No verified English nameCXSL2601147 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/19New drug · Class 1 注射用TQB6411 · No verified English nameCXSL2601146 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/10/19New drug · Class 1 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2601145 Shanghai Huai Yue Bio Technology Co., Ltd. romanized
2026/10/19New drug · Class 1 B1962注射液 · No verified English nameCXSL2601144 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2026/10/19New drug · Class 1 B1962注射液 · No verified English nameCXSL2601143 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2026/10/19New drug · Class 1 SHR-5670注射液 · No verified English nameCXSL2601142 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/19New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2601141 Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized
2026/10/19New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2601140 Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized
2026/10/19New drug · Class 1 注射用LY4170156 · No verified English nameCXSL2601139 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/10/19New drug · Class 1 联格列净片 · No verified English nameCXHS2600141 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2026/10/19New drug · Class 1 联格列净片 · No verified English nameCXHS2600140 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2026/10/19New drug · Class 1 PA-XP-102 · No verified English nameCXHL2601307 Zhong Ke Shuai Tian Pharmaceuticals (Shenzhen) Co., Ltd. romanized
2026/10/19New drug · Class 1 HPN-01肠溶胶囊 · No verified English nameCXHL2601306 He Bo Heng Sheng (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/10/19New drug · Class 1 HPN-01肠溶胶囊 · No verified English nameCXHL2601305 He Bo Heng Sheng (Shanghai) Pharmaceuticals Co., Ltd. romanized

80 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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