YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 406 drug applications between 26 August 2026 and 1 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 44 drug names.
2026/08/26 – 2026/09/01
- New acceptances this week
- 406
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 256
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
406filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 241 |
| Generic | 63 |
| New drug | 61 |
| Import | 33 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 131 |
| Therapeutic biologic | 76 |
| Prophylactic biologic | 8 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | 二硫化硒洗剂 · No verified English name | 3 | 2 | 14 |
| 3 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 4 | Rotigotine Patches | 3 | 1 | 7 |
| 5 | Mupirocin Ointment | 2 | 2 | 30 |
| 6 | Eplerenone Tablets | 2 | 1 | 4 |
| 7 | Orlistat Capsules | 2 | 1 | 8 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 10 | 甘油灌肠剂 · No verified English name | 2 | 1 | 2 |
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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Gao Miao Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 10 | 2 | 0 |
| 3 | Eli Lilly and Company | 9 | 3 | 0 |
| 4 | Novo Nordisk A/S | 9 | 2 | 0 |
| 5 | Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized | 7 | 4 | 0 |
| 6 | Novartis Pharma AG | 6 | 4 | 0 |
| 7 | Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | San Men Xia Guang Yu Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Haerbin Zhong Yao Si Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Topfond Pharmaceutical Co., Ltd. | 4 | 4 | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/01Import · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameJXSS2600084 | JETEMA Co. Ltd.; Zhejiang Ningbo Zhuoyi Biotechnology Co. Ltd. |
| 2026/09/01Import · Class 3.1 | 莫格利珠单抗注射液 · No verified English nameJXSS2600083 | Kyowa Kirin Co. Ltd.; Otsu Pharmaceuticals Plant TOYOBO CO. LTD. |
| 2026/09/01Import · Class 1 | XEP527胶囊 · No verified English nameJXHL2600381 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2026/09/01Import · Class 1 | XEP527胶囊 · No verified English nameJXHL2600380 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2026/09/01Import · Class 1 | XEP527胶囊 · No verified English nameJXHL2600379 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2026/09/01Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2602182 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/09/01Generic · Class 3 | Potassium Chloride GranulesCYHS2602172 | Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized |
| 2026/09/01Generic · Class 3 | 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2600093 | Hunan Mai Ou Medical Technology Co., Ltd. romanized |
| 2026/09/01New drug · Class 2.2 | 安儿宁口服液 · No verified English nameCXZL2600083 | Jin He Zang Yao Co., Ltd. romanized |
| 2026/09/01New drug · Class 1.1 | 双枣安神颗粒 · No verified English nameCXZL2600082 | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/01New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2600133 | Ai Mei Rong Yu (Ningbo) Biopharmaceutical Co., Ltd. romanized |
| 2026/09/01New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2600944 | Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | HY8931注射液 · No verified English nameCXSL2600943 | Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | HY8931注射液(皮下注射) · No verified English nameCXSL2600942 | Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | 注射用Tvac001个性化肿瘤新抗原多肽 · No verified English nameCXSL2600941 | Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | Tvac001新抗原反应性T细胞注射液 · No verified English nameCXSL2600940 | Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | HRS-7535片 · No verified English nameCXHS2600123 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | HRS-7535片 · No verified English nameCXHS2600122 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | RO7836748薄膜包衣片 · No verified English nameCXHL2601063 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | RO7836748薄膜包衣片 · No verified English nameCXHL2601062 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | RO7836748薄膜包衣片 · No verified English nameCXHL2601061 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | ACT001胶囊 · No verified English nameCXHL2601060 | Shang De Yao Yuan (Tianjin) Biopharmaceutical Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2601059 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/09/01New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2601058 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/08/31Import · Class 1 | 注射用MK-2750 · No verified English nameJXSL2600235 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/08/31Import · Class 1 | FUB523注射液 · No verified English nameJXSL2600234 | Novartis Pharma AG |
| 2026/08/31Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600378 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600377 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600376 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/31Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600375 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
85 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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