YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 498 drug applications between 8 August 2026 and 14 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 61 drug names.

2026/08/08 – 2026/08/14

Period
2026/08/08 to 2026/08/14, 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
498
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
260

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

498filings, 87 of them generic

By application type

Application typeFilings
Supplement296
Generic87
New drug64
Import37
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug244
TCM181
Therapeutic biologic66
Prophylactic biologic5
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

61 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

280 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1F. Hoffmann-La Roche Ltd1220
2Jilin Gao Miao Pharma Co., Ltd. romanized880
3AstraZeneca AB850
4Guangdong Tai En Kang Pharmaceutical Factory Co., Ltd. romanized830
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized830
6Xin Da Bio Technology Co., Ltd. romanized810
7Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized760
8Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized750
9Novo Nordisk A/S710
10Yi Chang Ren Fu Pharma Co., Ltd. romanized634

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

128 this week

AcceptedDrugApplicants
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600345 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600344 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600343 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600342 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600341 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600340 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/14Import · Class 1 LY4257496注射液 · No verified English nameJXHL2600339 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/08/14Import · Class 2.4 Rilzabrutinib片 · No verified English nameJXHL2600338 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/08/14Import · Class 2.2; 2.4 Rilzabrutinib微片 · No verified English nameJXHL2600337 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/08/14Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2602020 Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized
2026/08/14Generic · Class 3 Pregabalin Extended release TabletsCYHS2602018 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/14Generic · Class 3 Pregabalin Extended release TabletsCYHS2602017 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/14Generic · Class 3 Pregabalin Extended release TabletsCYHS2602016 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/08/14Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2602012 Tian Sheng Pharmaceutical Group Co., Ltd. romanized
2026/08/14Generic · Class 3 中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2602011 Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/08/14New drug · Class 1.1 皮炎消颗粒 · No verified English nameCXZL2600076 Shanxi Xin Zhou Xing Hua Pi Fu Bing Zhuan Ke Hospital romanized
2026/08/14New drug · Class 2.2 吸附无细胞百(五组分)白破联合疫苗 · No verified English nameCXSS2600123 Kang Xi Nuo Bio Shareholding Company romanized
2026/08/14New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600869 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600868 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 注射用MHB034C · No verified English nameCXSL2600867 Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/08/14New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2600866 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/08/14New drug · Class 1 注射用RT036 · No verified English nameCXSL2600865 Shanghai Ruo Tuo Bio Technology Co., Ltd. romanized
2026/08/14New drug · Class 1 GC012F注射液 · No verified English nameCXSL2600864 Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601007 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601006 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601005 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601004 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601003 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2601002 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/14New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601001 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

98 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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