YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 413 drug applications between 6 October 2026 and 12 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 49 drug names.
2026/10/06 – 2026/10/12
- New acceptances this week
- 413
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 367
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
413filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 217 |
| New drug | 76 |
| Generic | 73 |
| Import | 21 |
| Import re-registration | 18 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 218 |
| TCM | 118 |
| Therapeutic biologic | 75 |
| Biologic | 2 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Allopurinol Tablets | 3 | 2 | 4 |
| 2 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 3 | Dihydrocodeine Tartrate Sustained Realese Tablets | 3 | 1 | 3 |
| 4 | 二硫化硒洗剂 · No verified English name | 2 | 2 | 14 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Mupirocin Ointment | 2 | 2 | 30 |
| 7 | Dotinurad Tablets | 2 | 1 | 55 |
| 8 | Emedastine Difumarate Sustained-release Capsules | 2 | 1 | 11 |
| 9 | Brivaracetam Tablets | 2 | 1 | 19 |
| 10 | Ticagrelor Tablets | 2 | 1 | 10 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Dong E E Jiao Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Pfizer Inc. | 9 | 2 | 0 |
| 3 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | N. V. Organon | 8 | 1 | 0 |
| 5 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 7 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 8 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Merck Europe B.V. | 5 | 2 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/12Import · Class 2.2 | 法瑞西单抗注射液 · No verified English nameJXSS2600091 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
| 2026/10/12Import · Class 2.2 | 法瑞西单抗注射液 · No verified English nameJXSS2600090 | Roche Pharma (Schweiz) AG; Vetter Pharma-Fertigung GmbH & Co. KG |
| 2026/10/12Import · Class 2.2 | 泰它西普注射液 · No verified English nameJXSL2600271 | Vor Biopharma Inc.; RemeGen Co. Ltd. |
| 2026/10/12Import · Class 1 | LY888891混悬液 · No verified English nameJXSL2600270 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/12Import · Class 1 | LY5830966片 · No verified English nameJXHL2600440 | Ajax Therapeutics Inc. (a wholly owned subsidiary of Eli Lilly and Company); Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/10/12Import · Class 1 | Fenebrutinib片 · No verified English nameJXHL2600439 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/10/12Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2602503 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/10/12Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2602502 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/10/12Generic · Class 3 | Allopurinol TabletsCYHS2602495 | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2026/10/12Generic · Class 3 | Timolol Maleate Eye DropsCYHS2602494 | Chengdu Pusch Pharmaceutical Co., Ltd. |
| 2026/10/12Generic · Class 3 | Timolol Maleate Eye DropsCYHS2602493 | Chengdu Pusch Pharmaceutical Co., Ltd. |
| 2026/10/12Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2602492 | Chengdu Pusch Pharmaceutical Co., Ltd. |
| 2026/10/12Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2602491 | Shandong Nuo He Kang Pharma Co., Ltd. romanized |
| 2026/10/12Generic · Class 3 | 尿素[14C]胶囊 · No verified English nameCYHL2600114 | Hunan Sai Li Si Yi Xue Bio Technology Co., Ltd. romanized |
| 2026/10/12Generic · Class 3 | 美阿沙坦钾氯噻酮片 · No verified English nameCYHL2600113 | Beijing Foyou Pharma CO.,LTD |
| 2026/10/12Generic · Class 3 | 美阿沙坦钾氯噻酮片 · No verified English nameCYHL2600112 | Beijing Foyou Pharma CO.,LTD |
| 2026/10/12New drug · Class 3.1 | 半夏白术天麻汤颗粒 · No verified English nameCXZS2600053 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/10/12New drug · Class 2.2 | 消炎解毒合剂 · No verified English nameCXZL2600098 | Hubei Yi En Pharma Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 注射用GB268 · No verified English nameCXSL2601106 | Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | QH104A细胞注射液 · No verified English nameCXSL2601105 | Beijing Qing Hui Lian Nuo Bio Technology Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 抗狂犬病病毒全人源组合抗体注射液 · No verified English nameCXSL2601104 | Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized |
| 2026/10/12New drug · Class 2.2 | 注射用泰它西普 · No verified English nameCXSL2601103 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 注射用LM-338 · No verified English nameCXSL2601102 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 注射用QLS5314 · No verified English nameCXSL2601101 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 注射用HS-20122 · No verified English nameCXSL2601100 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/10/12New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2601099 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | SYS6072 · No verified English nameCXSL2601098 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/10/12New drug · Class 1 | 9MW5211注射液 · No verified English nameCXSL2601097 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/10/12New drug · Class 2.4 | 盐酸吉卡昔替尼片 · No verified English nameCXHS2600137 | Name not romanized |
| 2026/10/12New drug · Class 1 | HP570片 · No verified English nameCXHL2601261 | Hai Chuang Pharma 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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