YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 220 drug applications between 5 October 2024 and 11 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 41 drug names.
2024/10/05 – 2024/10/11
- New acceptances this week
- 220
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 1
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
220filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 98 |
| Generic | 56 |
| New drug | 32 |
| Import | 19 |
| Unspecified | 8 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 149 |
| Therapeutic biologic | 36 |
| TCM | 31 |
| Biologic | 2 |
| Prophylactic 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fusidic Acid Cream | 4 | 2 | 15 |
| 2 | Bupivacaine Hydrochloride Injection | 3 | 1 | 4 |
| 3 | Iguratimod Tablets | 2 | 2 | 23 |
| 4 | ω-3 Fish Oil Fat Emulsion Injection | 2 | 1 | 6 |
| 5 | Piracetam Injection | 2 | 1 | 9 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Pregabalin Capsules | 2 | 1 | 12 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 9 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
| 10 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 5 | 4 | 0 |
| 2 | Merck Sharp & Dohme B.V. | 5 | 3 | 0 |
| 3 | Eli Lilly and Company | 5 | 2 | 0 |
| 4 | AstraZeneca AB | 4 | 3 | 0 |
| 5 | Jenapharm GmbH & Co. KG | 4 | 2 | 0 |
| 6 | Pfizer Inc. | 4 | 2 | 0 |
| 7 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Bard Pharmaceuticals Limited | 3 | 3 | 0 |
| 10 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 3 | 3 | 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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/11Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2400087 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/10/11Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2400086 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/10/11Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400085 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/10/11Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400084 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/10/11Import · Class 1 | ABBV-400注射用粉末 · No verified English nameJXSL2400191 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/10/11Import · Class 2.4 | 甲磺酸兰泽替尼片 · No verified English nameJXHS2400076 | Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/10/11Import · Class 1 | AZD6234注射液 · No verified English nameJXHL2400243 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/10/11Import · Class 2.4 | 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400242 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/10/11Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2403381 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | Magnesium Sulfate InjectionCYHS2403376 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2403372 | Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2403371 | Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2403370 | Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | Nifedipine Extended-Release TabletsCYHS2403365 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2024/10/11Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403357 | Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2024/10/11New drug · Class 1.1 | 渴脉平颗粒 · No verified English nameCXZL2400065 | Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | 注射用ZHB015 · No verified English nameCXSL2400684 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | HCB101注射液 · No verified English nameCXSL2400683 | Guangzhou Han Ke Bio Co., Ltd. romanized |
| 2024/10/11New drug · Class 3.3 | 人生长激素注射液 · No verified English nameCXSL2400682 | Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1.2 | 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400681 | Na Mei Xin (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | SHR2554片 · No verified English nameCXHS2400102 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | SYH2062注射液 · No verified English nameCXHL2401052 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | BPR-30221616注射液 · No verified English nameCXHL2401051 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/10/11New drug · Class 1 | BPR-30221616注射液 · No verified English nameCXHL2401050 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/10/11New drug · Class 1 | DC10190胶囊 · No verified English nameCXHL2401049 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | DC10190胶囊 · No verified English nameCXHL2401048 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | ANS03片 · No verified English nameCXHL2401047 | Shenzhen An Shi Bio Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | ANS03片 · No verified English nameCXHL2401046 | Shenzhen An Shi Bio Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | BY101921片 · No verified English nameCXHL2401045 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/11New drug · Class 1 | BY101921片 · No verified English nameCXHL2401044 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
34 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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