YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 18 September 2025 and 24 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 53 drug names.
2025/09/18 – 2025/09/24
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 79
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
290filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 67 |
| New drug | 48 |
| Import | 11 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 170 |
| TCM | 69 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
| In vitro diagnostic reagent | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | 注射用泼尼松龙琥珀酸钠 · No verified English name | 3 | 1 | 3 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 5 | Levocarnitine Oral Solution | 2 | 1 | 9 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 2 | 1 | 10 |
| 7 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
| 10 | Mometasone Furoate Cream | 2 | 1 | 16 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ke Lun Pharma Co., Ltd. romanized | 15 | 2 | 0 |
| 2 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 3 | 0 |
| 6 | Hangzhou Minsheng Pharmaceutical Co., Ltd | 4 | 2 | 0 |
| 7 | Rui Shi Biopharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Lichtenheldt GmbH | 3 | 3 | 0 |
| 9 | Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 3 | 3 | 1 |
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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/24Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2500297 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2025/09/24Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2500296 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2025/09/24New drug · Class 2.2 | 颅痛宁丸(浓缩丸) · No verified English nameCXZL2500085 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2025/09/24New drug · Class 3.2 | 布瑞基奥仑赛注射液 · No verified English nameCXSS2500101 | Fu Xing Kai Rui (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2500100 | Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized |
| 2025/09/24New drug · Class 3.3 | BR206注射液 · No verified English nameCXSL2500818 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2500817 | Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | IMM092注射液 · No verified English nameCXSL2500816 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | IMM040811注射液 · No verified English nameCXSL2500815 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | 177Lu-LNC1009注射液 · No verified English nameCXHL2501029 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | Exd391209注射液 · No verified English nameCXHL2501028 | Chengdu Ao Da Bio Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 2.2 | DM0205透皮贴剂 · No verified English nameCXHL2501027 | Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 2.2; 2.4 | 纳米炭铁混悬注射液 · No verified English nameCXHL2501026 | Sichuan Ying Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | RSS0343片 · No verified English nameCXHL2501025 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/24New drug · Class 1 | RSS0343片 · No verified English nameCXHL2501024 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/23Import · Class 2.2 | 艾可瑞妥单抗注射液 · No verified English nameJXSS2500128 | AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/09/23Import · Class 2.2 | 艾可瑞妥单抗注射液 · No verified English nameJXSS2500127 | AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/09/23Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2503490 | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized |
| 2025/09/23Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2503489 | Sichuan Sheng Yu Xin Pharma Co., Ltd. romanized; Tong Fang Pharma (Beijing) Co., Ltd. romanized |
| 2025/09/23New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSS2500099 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500814 | You Sai Sheng Ming Ke Xue Development Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | 注射用ATG-022 ADC · No verified English nameCXSL2500813 | De Qi (Hangzhou) Bio Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | SHR7280片 · No verified English nameCXHS2500118 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | RSS0343片 · No verified English nameCXHL2501023 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | RSS0343片 · No verified English nameCXHL2501022 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | XRF-1021片 · No verified English nameCXHL2501021 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/09/23New drug · Class 1 | XRF-1021片 · No verified English nameCXHL2501020 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/09/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2500108 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2500107 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/22Import · Class 1 | LY3537021注射液 · No verified English nameJXHL2500295 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
46 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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