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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 466 drug applications between 15 July 2026 and 21 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 53 drug names.

2026/07/15 – 2026/07/21

Period
2026/07/15 to 2026/07/21, 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
466
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
161

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

466filings, 78 of them generic

By application type

Application typeFilings
Supplement287
Generic78
New drug65
Import22
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug234
TCM153
Therapeutic biologic69
Prophylactic biologic8
Biologic2

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

53 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

274 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Ji Er Ji Pharma Co., Ltd. romanized10100
2Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized1090
3Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized990
4Pfizer Inc.730
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6An Kang Zheng Da Pharmaceutical Co., Ltd. romanized650
7Fresenius Kabi Austria GmbH610
8Shanxi Hua Kang Pharma Co., Ltd. romanized540
9Novo Nordisk A/S520
10Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520

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

114 this week

AcceptedDrugApplicants
2026/07/21Import · Class 1 PF-08634404 · No verified English nameJXSL2600173 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600282 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600281 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600280 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Generic · Class 3 布美他尼片 · No verified English nameCYHS2601746 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2026/07/21Generic · Class 3 Nystatin Oral SuspensionCYHS2601742 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2026/07/21Generic · Class 3 富马酸伊布利特注射液 · No verified English nameCYHS2601741 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2026/07/21New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2600037 Shandong Qidu Pharmaceutical Co., Ltd.
2026/07/21New drug · Class 1 金妥昔单抗注射液 · No verified English nameCXSS2600110 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/21New drug · Class 1 注射用VBC117 · No verified English nameCXSL2600753 Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized
2026/07/21New drug · Class 2.3 沙库巴曲阿利沙坦氨氯地平片 · No verified English nameCXHS2600105 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/07/21New drug · Class 1 IBI3042 · No verified English nameCXHL2600890 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/21New drug · Class 1 IBI3042 · No verified English nameCXHL2600889 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/21New drug · Class 1 IBI3042 · No verified English nameCXHL2600888 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/21New drug · Class 1 IBI3042 · No verified English nameCXHL2600887 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/21New drug · Class 1 BG-75098片 · No verified English nameCXHL2600886 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BG-75098片 · No verified English nameCXHL2600885 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BG-75098片 · No verified English nameCXHL2600884 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600883 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600882 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600881 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/21New drug · Class 1 BGB-43395片 · No verified English nameCXHL2600880 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/20Import · Class 3.1 伊匹木单抗注射液 · No verified English nameJXSS2600063 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Samsung Biologics Co. Ltd; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/07/20Import · Class 1 AZD5335 · No verified English nameJXSL2600172 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/20Import · Class 2.4 贝组替凡片 · No verified English nameJXHL2600279 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/20Import · Class 2.4 塞伐艾替尼片 · No verified English nameJXHL2600278 Bayer AG; Bayer Healthcare Company Ltd.
2026/07/20Import · Class 2.4 塞伐艾替尼片 · No verified English nameJXHL2600277 Bayer AG; Bayer Healthcare Company Ltd.
2026/07/20Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2601737 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2026/07/20Generic · Class 3 布美他尼片 · No verified English nameCYHS2601736 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/07/20Generic · Class 3 Potassium Chloride InjectionCYHS2601732 Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Xian Li Jun Kang Le Pharmaceutical Co., Ltd. romanized

84 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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